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TerminatedNCT00430300Updated Jul 8, 2013Results posted

Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.

A Phase 2 interventional study of UK-432,097 and Placebo in Pulmonary Disease, Chronic Obstructive, sponsored by Pfizer. Terminated at 22 sites in 5 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-07-08.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • Dry Powder for Inhalation
  • Chronic Obstructive Pulmonary Disease
  • Lung Function testing
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 87 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease
  • Patients must have a smoking history of at least 10 pack-years
  • Patients must have stable disease for at least 1 month prior to screening.

Exclusion criteria

Exclusion Criteria:

  • More than 2 exacerbations of COPD in the preceding year
  • History of a lower respiratory tract infection or significant disease instability during the month proceding screening or during the time between screen and randomization.
  • History or presence of respiratory failure, cor pulmonale or right ventricular failure
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
87 participants (actual)

Study arms

  • Experimental
    150mcg, 450mcg or 1350mcg

    Active treatment given BID via a double pin monodose capsule inhaler device

    Drug: UK-432,097

  • Placebo comparator
    Placebo

    Placebo treatment given BID via a single pin monodose inhaler device

    Drug: Placebo

Interventions

  • DrugUK-432,097

    Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.

  • DrugPlacebo

    Capsules containing 100% lactose administered BID using an atomizer device

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6

    FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.

    Time frame: Pre-dose at Baseline, Week 6

Secondary outcomes

  1. Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8

    FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.

    Time frame: Pre-dose at Baseline, Week 2, 4, 8

  2. Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8

    FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Trough FEV6 was obtained from spirometry, performed before study treatment administration.

    Time frame: Pre-dose at Baseline, Week 2, 4, 6, 8

  3. Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8

    FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.

    Time frame: Pre-dose at Baseline, Week 2, 4, 6, 8

  4. Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8

    IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Trough IC was obtained from spirometry, performed before study treatment administration.

    Time frame: Pre-dose at Baseline, Week 2, 4, 6, 8

  5. Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6

    FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration.

    Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6

  6. Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6

    FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-study drug FEV6 was obtained from spirometry, performed 15-30 minutes after study treatment administration.

    Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6

  7. Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6

    FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-study drug FVC was obtained from spirometry, performed 15-30 minutes after study treatment administration.

    Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6

  8. Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6

    IC is the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-study drug IC was obtained from spirometry, performed 15-30 minutes after study treatment administration.

    Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6

  9. Change From Baseline in Post-Bronchodilator FEV1 at Week 6

    FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-bronchodilator FEV1 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.

    Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6

  10. Change From Baseline in Post-Bronchodilator FEV6 at Week 6

    FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-bronchodilator FEV6 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.

    Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6

  11. Change From Baseline in Post-Bronchodilator FVC at Week 6

    FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.

    Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6

  12. Change From Baseline in Post-Bronchodilator IC at Week 6

    IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-bronchodilator IC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.

    Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6

  13. Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6

    BDI: 24-item questionnaire to assess baseline dyspnea in 3 domains, functional impairment; magnitude of task; magnitude of effort. Each item rated on 5-point scale: 0 (very severe), 4 (no impairment). BDI total score range: 0 to 12, lower score=more severe dyspnea. TDI: 24-item questionnaire to measure changes in dyspnea severity from baseline in same 3 domains, as in BDI. Each item rated on 7-point scale: -3 (major deterioration) to 3 (major improvement). TDI total score range: -9 to 9, lower score=more deterioration. BDI/TDI total scores were obtained by adding scores for each of 3 domains.

    Time frame: Baseline, Week 2, 4, 6

  14. Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8

    COPD symptom score: participants rated the severity of their COPD symptoms (cough, breathlessness, and sputum production) in daily symptom dairy according to how they felt during the past 24 hours on a 4-point scale ranging from 0 (none) to 3 (severe). A participant's daily score for each symptom was averaged over each week.

    Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

  15. Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8

    Participants were issued with rescue medication (Salbutamol MDI \[100 mcg/actuation\]) and were instructed to use 1-2 puffs as required, as a rescue therapy. All rescue medication use was recorded in daily paper dairy by participant. A participant's daily use (puffs/day) was averaged over each week.

    Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

  16. Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8

    The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with a hand-held peak flow device and instructed to perform twice daily (morning and evening) prior to taking any medication. A participant's daily values were averaged over each week.

    Time frame: Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

  17. Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)

    CGI-C: clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.

    Time frame: Week 6

  18. Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)

    PGI-C: participant rated instrument to measure participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.

    Time frame: Week 6

Other outcomes

  1. Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6

    Pulse rate: the number of pulsations noted in a peripheral artery per unit of time after participant rested supine for 5 minutes, reported as beats per minute (bpm).

    Time frame: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4

  2. Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6

    BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). BP was measured by sphygmomanometer (manual or semi-automated) using appropriate-sized and calibrated cuff after participant rested in supine position for 5 minutes.

    Time frame: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4

  3. Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8

    Standard 12-lead ECG was performed after participant has rested for at least 10 minutes in supine position. ECG intervals (Int) included PR Int (time between onset of atrial depolarization and onset of ventricular depolarization), QRS Int (represented ventricular depolarization), RR Int (time between 2 QRS complex), QT Int (time corresponding to the beginning of depolarization to repolarization of the ventricles), corrected QT (QTc) Int, QT Int corrected by Fridericia's formula (QTcF=QT divided by cube root of RR Int) and Bazett's formula (QTcB=QT divided by square root of RR Int).

    Time frame: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)

  4. Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8

    Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.

    Time frame: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)

  5. Change in Post-Study Drug Forced Expiratory Volume in 1 Second (FEV1) Compared to Pre-Study Drug Forced Expiratory Volume in 1 Second (FEV1) at Week 0, 1, 2, 4, and 6

    FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration. Pre-study drug FEV1 was obtained from spirometry, performed before study treatment administration.

    Time frame: Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6

07

Results

Posted Jul 8, 2013
Limitations and caveats
Study was terminated prematurely due to futility based on results of interim analysis.

Participant flow

Participant flow — Overall Study
MilestoneUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Started17183517
Completed15162915
Not completed2262
Withdrew: Adverse event0211
Withdrew: Withdrawal by subject1050
Withdrew: Laboratory abnormality1000
Withdrew: Other0001

Outcome measures

PrimaryChange From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6

FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.

Time frame:
Pre-dose at Baseline, Week 6
Reported as:
Mean · liter
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6
literUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Baseline (n= 16, 17, 32, 16)1.40 ± 0.451.48 ± 0.571.41 ± 0.391.33 ± 0.48
Change at Week 6 (n= 14, 17, 29, 15)-0.01 ± 0.21-0.05 ± 0.18-0.05 ± 0.18-0.05 ± 0.16
Statistical analysis
  • UK-432,097 150 Mcg vs Placebo · Bayesian NDLM model · p = 0.0284 · Ndlm estimate difference: -0.0087 · 95% CI -0.0943 to 0.0774
  • UK-432,097 450 Mcg vs Placebo · Bayesian NDLM model · p = 0.0056 · Ndlm estimate difference: -0.0389 · 95% CI -0.1299 to 0.0471
  • UK-432,097 1350 Mcg vs Placebo · Bayesian NDLM model · p = 0.0009 · Ndlm estimate difference: -0.0510 · 95% CI -0.1298 to 0.0290
SecondaryChange From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8

FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.

Time frame:
Pre-dose at Baseline, Week 2, 4, 8
Reported as:
Mean · liter
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8
literUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Change at Week 2 (n= 16, 17, 32, 16)-0.01 ± 0.10-0.10 ± 0.110.01 ± 0.130.01 ± 0.18
Change at Week 4 (n= 15, 17, 30, 16)-0.08 ± 0.19-0.06 ± 0.15-0.02 ± 0.17-0.01 ± 0.12
Change at Week 8 (n= 14, 16, 27, 16)0.03 ± 0.23-0.07 ± 0.180.04 ± 0.23-0.05 ± 0.17
Statistical analysis
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.5849 · Adjusted mean difference: -0.01
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.9737 · Adjusted mean difference: -0.09
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.3870 · Adjusted mean difference: 0.01
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.8612 · Adjusted mean difference: -0.06
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.7499 · Adjusted mean difference: -0.04
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.5134 · Adjusted mean difference: -0.00
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.1244 · Adjusted mean difference: 0.08
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.5300 · Adjusted mean difference: -0.01
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.0550 · Adjusted mean difference: 0.10
SecondaryChange From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8

FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Trough FEV6 was obtained from spirometry, performed before study treatment administration.

Time frame:
Pre-dose at Baseline, Week 2, 4, 6, 8
Reported as:
Mean · liter
Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8
literUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Baseline (n= 16, 17, 32, 16)2.66 ± 0.732.80 ± 0.812.75 ± 0.692.54 ± 0.73
Change at Week 2 (n= 16, 17, 32, 16)-0.02 ± 0.22-0.08 ± 0.18-0.01 ± 0.200.03 ± 0.19
Change at Week 4 (n= 15, 17, 30, 16)-0.12 ± 0.240.03 ± 0.19-0.05 ± 0.23-0.01 ± 0.13
Change at Week 6 (n= 14, 17, 29, 15)-0.00 ± 0.250.01 ± 0.30-0.06 ± 0.22-0.05 ± 0.18
Change at Week 8 (n= 14, 16, 27, 16)0.10 ± 0.34-0.05 ± 0.310.04 ± 0.30-0.09 ± 0.26
Statistical analysis
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.7444 · Adjusted mean difference: -0.05
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.9134 · Adjusted mean difference: -0.10
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.6841 · Adjusted mean difference: -0.03
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9283 · Adjusted mean difference: -0.11
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.2991 · Adjusted mean difference: 0.04
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.7403 · Adjusted mean difference: -0.04
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.3499 · Adjusted mean difference: 0.03
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.2734 · Adjusted mean difference: 0.05
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.5806 · Adjusted mean difference: -0.02
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.0540 · Adjusted mean difference: 0.18
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.2616 · Adjusted mean difference: 0.07
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.0724 · Adjusted mean difference: 0.14
SecondaryChange From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8

FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.

Time frame:
Pre-dose at Baseline, Week 2, 4, 6, 8
Reported as:
Mean · liter
Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8
literUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Baseline (n= 16, 17, 32, 16)3.11 ± 0.853.43 ± 1.163.24 ± 0.913.01 ± 0.94
Change at Week 2 (n= 16, 17, 32, 16)-0.07 ± 0.30-0.09 ± 0.30-0.04 ± 0.250.09 ± 0.31
Change at Week 4 (n= 15, 17, 30, 16)-0.14 ± 0.340.14 ± 0.21-0.02 ± 0.320.05 ± 0.21
Change at Week 6 (n= 14, 17, 29, 15)0.01 ± 0.320.01 ± 0.33-0.01 ± 0.310.02 ± 0.17
Change at Week 8 (n= 14, 16, 27, 16)0.14 ± 0.460.02 ± 0.400.07 ± 0.33-0.05 ± 0.28
Statistical analysis
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9362 · Adjusted mean difference: -0.15
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.9469 · Adjusted mean difference: -0.16
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.9153 · Adjusted mean difference: -0.12
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9686 · Adjusted mean difference: -0.19
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.1548 · Adjusted mean difference: 0.10
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.7973 · Adjusted mean difference: -0.07
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.6348 · Adjusted mean difference: -0.04
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.5742 · Adjusted mean difference: -0.02
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.6719 · Adjusted mean difference: -0.04
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.0881 · Adjusted mean difference: 0.18
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.2772 · Adjusted mean difference: 0.07
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.1363 · Adjusted mean difference: 0.12
SecondaryChange From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8

IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Trough IC was obtained from spirometry, performed before study treatment administration.

Time frame:
Pre-dose at Baseline, Week 2, 4, 6, 8
Reported as:
Mean · liter
Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8
literUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Baseline (n= 16, 17, 32, 16)2.44 ± 0.632.81 ± 0.782.53 ± 0.592.41 ± 0.82
Change at Week 2 (n= 16, 17, 32, 16)0.03 ± 0.27-0.06 ± 0.38-0.03 ± 0.30-0.10 ± 0.24
Change at Week 4 (n= 15, 17, 30, 16)-0.05 ± 0.18-0.03 ± 0.38-0.15 ± 0.28-0.06 ± 0.25
Change at Week 6 (n= 14, 17, 29, 15)-0.03 ± 0.23-0.08 ± 0.40-0.14 ± 0.28-0.09 ± 0.32
Change at Week 8 (n= 14, 16, 27, 16)0.07 ± 0.220.01 ± 0.44-0.10 ± 0.33-0.05 ± 0.26
Statistical analysis
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.0938 · Adjusted mean difference: 0.14
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.2149 · Adjusted mean difference: 0.08
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.1682 · Adjusted mean difference: 0.09
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.4492 · Adjusted mean difference: 0.01
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.2539 · Adjusted mean difference: 0.07
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.8168 · Adjusted mean difference: -0.08
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.3248 · Adjusted mean difference: 0.05
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.3148 · Adjusted mean difference: 0.05
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.6563 · Adjusted mean difference: -0.04
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.1735 · Adjusted mean difference: 0.12
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.1237 · Adjusted mean difference: 0.14
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.6113 · Adjusted mean difference: -0.03
SecondaryChange From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6

FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration.

Time frame:
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Reported as:
Mean · liter
Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6
literUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Baseline (n= 16, 17, 32, 16)1.40 ± 0.451.48 ± 0.571.41 ± 0.391.33 ± 0.48
Change at Week 2 (n= 16, 16, 30, 16)0.02 ± 0.11-0.10 ± 0.16-0.02 ± 0.110.03 ± 0.20
Change at Week 4 (n= 14, 16, 29, 16)-0.07 ± 0.15-0.04 ± 0.10-0.02 ± 0.15-0.01 ± 0.15
Change at Week 6 (n= 13, 16, 27, 15)-0.06 ± 0.23-0.04 ± 0.18-0.04 ± 0.15-0.03 ± 0.20
Statistical analysis
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.5549 · Adjusted mean difference: -0.01
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.9880 · Adjusted mean difference: -0.11
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.8572 · Adjusted mean difference: -0.05
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.8402 · Adjusted mean difference: -0.05
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.6562 · Adjusted mean difference: -0.02
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.5632 · Adjusted mean difference: -0.01
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.6370 · Adjusted mean difference: -0.02
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.4686 · Adjusted mean difference: 0.01
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.6164 · Adjusted mean difference: -0.02
SecondaryChange From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6

FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-study drug FEV6 was obtained from spirometry, performed 15-30 minutes after study treatment administration.

Time frame:
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6

No measurements were reported for this outcome.

SecondaryChange From Baseline in Post-Study Drug FVC at Week 2, 4, and 6

FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-study drug FVC was obtained from spirometry, performed 15-30 minutes after study treatment administration.

Time frame:
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6

No measurements were reported for this outcome.

SecondaryChange From Baseline in Post-Study Drug IC at Week 2, 4, and 6

IC is the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-study drug IC was obtained from spirometry, performed 15-30 minutes after study treatment administration.

Time frame:
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6

No measurements were reported for this outcome.

SecondaryChange From Baseline in Post-Bronchodilator FEV1 at Week 6

FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-bronchodilator FEV1 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.

Time frame:
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Reported as:
Mean · liter
Change From Baseline in Post-Bronchodilator FEV1 at Week 6
literUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Baseline0.32 ± 0.200.29 ± 0.190.26 ± 0.180.24 ± 0.15
Change at Week 60.06 ± 0.140.03 ± 0.19-0.02 ± 0.19-0.06 ± 0.14
SecondaryChange From Baseline in Post-Bronchodilator FEV6 at Week 6

FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-bronchodilator FEV6 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.

Time frame:
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6

No measurements were reported for this outcome.

SecondaryChange From Baseline in Post-Bronchodilator FVC at Week 6

FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.

Time frame:
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6

No measurements were reported for this outcome.

SecondaryChange From Baseline in Post-Bronchodilator IC at Week 6

IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-bronchodilator IC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.

Time frame:
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6

No measurements were reported for this outcome.

SecondaryChange From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6

BDI: 24-item questionnaire to assess baseline dyspnea in 3 domains, functional impairment; magnitude of task; magnitude of effort. Each item rated on 5-point scale: 0 (very severe), 4 (no impairment). BDI total score range: 0 to 12, lower score=more severe dyspnea. TDI: 24-item questionnaire to measure changes in dyspnea severity from baseline in same 3 domains, as in BDI. Each item rated on 7-point scale: -3 (major deterioration) to 3 (major improvement). TDI total score range: -9 to 9, lower score=more deterioration. BDI/TDI total scores were obtained by adding scores for each of 3 domains.

Time frame:
Baseline, Week 2, 4, 6
Reported as:
Mean · units on a scale
Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6
units on a scaleUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
BDI (n= 16, 17, 32, 16)7.1 ± 1.97.6 ± 2.17.2 ± 2.17.1 ± 2.0
TDI at Week 2 (n= 16, 17, 32, 16)-0.2 ± 1.90.8 ± 1.90.2 ± 1.11.3 ± 2.4
TDI at Week 4 (n= 15, 17, 31, 16)0.5 ± 2.80.2 ± 1.7-0.3 ± 1.90.3 ± 2.2
TDI at Week 6 (n= 14, 16, 29, 15)-0.6 ± 2.30.9 ± 3.10.1 ± 2.41.0 ± 1.9
Statistical analysis
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9885 · Adjusted mean difference: -1.4
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.8055 · Adjusted mean difference: -0.5
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.9759 · Adjusted mean difference: -1.1
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.4401 · Adjusted mean difference: 0.1
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.5957 · Adjusted mean difference: -0.2
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.8302 · Adjusted mean difference: -0.6
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9657 · Adjusted mean difference: -1.6
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.6378 · Adjusted mean difference: -0.3
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.8990 · Adjusted mean difference: -1.0
SecondaryChange From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8

COPD symptom score: participants rated the severity of their COPD symptoms (cough, breathlessness, and sputum production) in daily symptom dairy according to how they felt during the past 24 hours on a 4-point scale ranging from 0 (none) to 3 (severe). A participant's daily score for each symptom was averaged over each week.

Time frame:
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Reported as:
Mean · units on a scale
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8
units on a scaleUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Cough: Baseline (n= 16, 17, 31, 16)1.09 ± 0.500.77 ± 0.751.11 ± 0.671.06 ± 0.61
Cough: Change at Week 1 (n= 16, 17, 31, 16)-0.08 ± 0.460.11 ± 0.480.07 ± 0.410.10 ± 0.50
Cough: Change at Week 2 (n= 16, 15, 31, 16)-0.10 ± 0.430.13 ± 0.310.10 ± 0.53-0.01 ± 0.41
Cough: Change at Week 3 (n= 15, 17, 31, 16)-0.06 ± 0.510.15 ± 0.320.07 ± 0.480.15 ± 0.41
Cough: Change at Week 4 (n= 14, 17, 30, 16)-0.04 ± 0.300.07 ± 0.38-0.03 ± 0.460.18 ± 0.39
Cough: Change at Week 5 (n= 15, 17, 30, 16)-0.13 ± 0.380.04 ± 0.440.10 ± 0.730.00 ± 0.43
Cough: Change at Week 6 (n= 15, 17, 30, 15)-0.10 ± 0.360.04 ± 0.430.07 ± 0.77-0.02 ± 0.40
Cough: Change at Week 7 (n= 15, 16, 30, 15)-0.16 ± 0.38-0.08 ± 0.570.00 ± 0.640.07 ± 0.31
Cough: Change at Week 8 (n= 15, 16, 28, 15)-0.15 ± 0.370.00 ± 0.56-0.15 ± 0.600.07 ± 0.47
Breathlessness: Baseline (n= 16, 17, 31, 16)1.31 ± 0.591.30 ± 0.601.15 ± 0.751.27 ± 0.54
Breathlessness: Change at Week 1(n=16, 17, 31, 16)-0.24 ± 0.45-0.10 ± 0.31-0.05 ± 0.230.00 ± 0.32
Breathlessness: Change at Week 2(n=16, 15, 31, 16)-0.13 ± 0.48-0.11 ± 0.290.00 ± 0.33-0.01 ± 0.38
Breathlessness: Change at Week 3(n=15, 17, 31, 16)-0.12 ± 0.57-0.15 ± 0.330.02 ± 0.330.13 ± 0.41
Breathlessness: Change at Week 4(n=14, 17, 30, 16)-0.18 ± 0.50-0.16 ± 0.50-0.07 ± 0.280.18 ± 0.34
Breathlessness: Change at Week 5(n=15, 17, 30, 16)-0.14 ± 0.47-0.22 ± 0.50-0.06 ± 0.330.13 ± 0.40
Breathlessness: Change at Week 6(n=15, 17, 30, 15)-0.12 ± 0.56-0.03 ± 0.50-0.05 ± 0.340.12 ± 0.47
Breathlessness: Change at Week 7(n=15, 16, 30, 15)-0.06 ± 0.43-0.21 ± 0.480.01 ± 0.360.10 ± 0.43
Breathlessness: Change at Week 8(n=15, 16, 28, 15)-0.04 ± 0.49-0.13 ± 0.51-0.04 ± 0.490.08 ± 0.45
Sputum: Baseline (n= 16, 17, 31, 16)1.00 ± 0.620.76 ± 0.790.95 ± 0.590.90 ± 0.61
Sputum: Change at Week 1 (n= 16, 17, 31, 16)-0.07 ± 0.260.10 ± 0.360.04 ± 0.390.04 ± 0.41
Sputum: Change at Week 2 (n= 16, 15, 31, 16)-0.05 ± 0.200.17 ± 0.370.14 ± 0.540.05 ± 0.52
Sputum: Change at Week 3 (n= 15, 17, 31, 16)-0.08 ± 0.320.20 ± 0.370.15 ± 0.520.05 ± 0.41
Sputum: Change at Week 4 (n= 14, 17, 30, 16)0.01 ± 0.210.15 ± 0.360.06 ± 0.510.01 ± 0.47
Sputum: Change at Week 5 (n= 15, 17, 30, 16)0.06 ± 0.230.15 ± 0.330.07 ± 0.48-0.04 ± 0.44
Sputum: Change at Week 6 (n= 15, 17, 30, 15)0.09 ± 0.090.10 ± 0.460.10 ± 0.61-0.02 ± 0.51
Sputum: Change at Week 7 (n= 15, 15, 30, 15)0.08 ± 0.23-0.02 ± 0.390.07 ± 0.560.03 ± 0.51
Sputum: Change at Week 8 (n= 15, 15, 28, 15)0.07 ± 0.27-0.06 ± 0.400.02 ± 0.47-0.03 ± 0.55
Statistical analysis
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.8757 · Adjusted mean difference: -0.17
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.6334 · Adjusted mean difference: -0.05
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.5448 · Adjusted mean difference: -0.01
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.6986 · Adjusted mean difference: -0.08
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.3151 · Adjusted mean difference: 0.08
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.1802 · Adjusted mean difference: 0.12
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9102 · Adjusted mean difference: -0.22
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.6391 · Adjusted mean difference: -0.06
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.6838 · Adjusted mean difference: -0.07
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9648 · Adjusted mean difference: -0.26
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.8961 · Adjusted mean difference: -0.17
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.9534 · Adjusted mean difference: -0.21
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.7726 · Adjusted mean difference: -0.14
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.5665 · Adjusted mean difference: -0.03
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.2684 · Adjusted mean difference: 0.10
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.6485 · Adjusted mean difference: -0.07
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.4821 · Adjusted mean difference: 0.01
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.2557 · Adjusted mean difference: 0.11
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9031 · Adjusted mean difference: -0.23
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.8634 · Adjusted mean difference: -0.19
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.6375 · Adjusted mean difference: -0.05
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.8775 · Adjusted mean difference: -0.21
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.7191 · Adjusted mean difference: -0.10
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.8677 · Adjusted mean difference: -0.18
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9838 · Adjusted mean difference: -0.24
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.8106 · Adjusted mean difference: -0.10
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.7750 · Adjusted mean difference: -0.07
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.8082 · Adjusted mean difference: -0.11
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.7678 · Adjusted mean difference: -0.09
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.5373 · Adjusted mean difference: -0.01
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9548 · Adjusted mean difference: -0.24
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.9743 · Adjusted mean difference: -0.27
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.8408 · Adjusted mean difference: -0.12
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9887 · Adjusted mean difference: -0.32
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.9918 · Adjusted mean difference: -0.33
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.9833 · Adjusted mean difference: -0.26
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9619 · Adjusted mean difference: -0.26
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.9917 · Adjusted mean difference: -0.34
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.9376 · Adjusted mean difference: -0.19
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9084 · Adjusted mean difference: -0.21
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.7906 · Adjusted mean difference: -0.12
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.8765 · Adjusted mean difference: -0.16
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.8469 · Adjusted mean difference: -0.15
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.9717 · Adjusted mean difference: -0.27
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.7591 · Adjusted mean difference: -0.09
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.7141 · Adjusted mean difference: -0.10
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.8104 · Adjusted mean difference: -0.15
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.7664 · Adjusted mean difference: -0.11
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.7888 · Adjusted mean difference: -0.10
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.3930 · Adjusted mean difference: 0.03
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.4785 · Adjusted mean difference: 0.01
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.6756 · Adjusted mean difference: -0.07
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.2627 · Adjusted mean difference: 0.10
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.2281 · Adjusted mean difference: 0.11
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.7656 · Adjusted mean difference: -0.12
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.2105 · Adjusted mean difference: 0.13
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.2221 · Adjusted mean difference: 0.11
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.4396 · Adjusted mean difference: 0.02
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.2243 · Adjusted mean difference: 0.11
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.3597 · Adjusted mean difference: 0.05
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.2030 · Adjusted mean difference: 0.12
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.1207 · Adjusted mean difference: 0.16
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.1836 · Adjusted mean difference: 0.11
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.2359 · Adjusted mean difference: 0.12
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.2861 · Adjusted mean difference: 0.09
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.2151 · Adjusted mean difference: 0.12
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.3545 · Adjusted mean difference: 0.06
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.7102 · Adjusted mean difference: -0.09
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.3883 · Adjusted mean difference: 0.04
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.2228 · Adjusted mean difference: 0.12
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.6342 · Adjusted mean difference: -0.05
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.3141 · Adjusted mean difference: 0.07
SecondaryChange From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8

Participants were issued with rescue medication (Salbutamol MDI \[100 mcg/actuation\]) and were instructed to use 1-2 puffs as required, as a rescue therapy. All rescue medication use was recorded in daily paper dairy by participant. A participant's daily use (puffs/day) was averaged over each week.

Time frame:
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Reported as:
Mean · puffs/day
Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8
puffs/dayUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Baseline (n= 14, 15, 27, 15)2.87 ± 2.913.32 ± 2.992.97 ± 2.833.46 ± 3.26
Change at Week 1 (n= 14, 15, 27, 15)-0.24 ± 0.51-0.17 ± 0.53-0.19 ± 0.61-0.41 ± 1.11
Change at Week 2 (n= 13, 13, 27, 15)-0.26 ± 0.58-0.14 ± 0.67-0.08 ± 0.850.01 ± 1.09
Change at Week 3 (n= 13, 14, 27, 15)-0.12 ± 0.63-0.10 ± 0.790.03 ± 0.950.17 ± 1.31
Change at Week 4 (n= 13, 14, 26, 15)-0.19 ± 0.56-0.01 ± 0.99-0.08 ± 0.990.07 ± 1.00
Change at Week 5 (n= 13, 14, 26, 15)-0.44 ± 0.98-0.22 ± 1.390.21 ± 1.320.13 ± 0.93
Change at Week 6 (n= 13, 14, 24, 14)-0.39 ± 1.170.15 ± 1.160.26 ± 1.520.30 ± 1.10
Change at Week 7 (n= 13, 13, 26, 14)-0.20 ± 1.05-0.01 ± 1.810.38 ± 1.410.24 ± 0.99
Change at Week 8 (n= 13, 13, 25, 14)-0.17 ± 1.310.02 ± 1.510.30 ± 1.470.40 ± 1.17
Statistical analysis
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.2700 · Adjusted mean difference: 0.16
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.1831 · Adjusted mean difference: 0.24
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.1796 · Adjusted mean difference: 0.21
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.8136 · Adjusted mean difference: -0.28
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.6877 · Adjusted mean difference: -0.15
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.6382 · Adjusted mean difference: -0.09
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.7660 · Adjusted mean difference: -0.26
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.7226 · Adjusted mean difference: -0.21
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.6634 · Adjusted mean difference: -0.13
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.7598 · Adjusted mean difference: -0.25
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.5300 · Adjusted mean difference: -0.03
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.7054 · Adjusted mean difference: -0.16
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.8851 · Adjusted mean difference: -0.55
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.7575 · Adjusted mean difference: -0.31
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.4325 · Adjusted mean difference: 0.07
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.8934 · Adjusted mean difference: -0.60
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.5283 · Adjusted mean difference: -0.03
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.4900 · Adjusted mean difference: 0.01
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.7465 · Adjusted mean difference: -0.34
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.5848 · Adjusted mean difference: -0.11
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.3178 · Adjusted mean difference: 0.21
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.8169 · Adjusted mean difference: -0.47
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.6727 · Adjusted mean difference: -0.23
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.5014 · Adjusted mean difference: -0.00
SecondaryChange From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8

The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with a hand-held peak flow device and instructed to perform twice daily (morning and evening) prior to taking any medication. A participant's daily values were averaged over each week.

Time frame:
Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Reported as:
Mean · liter per minute
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8
liter per minuteUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Morning PEFR: Baseline (n= 16, 17, 32, 16)220.0 ± 113.0236.4 ± 121.4213.6 ± 72.6191.0 ± 77.8
Morning PEFR: Change at Week 1 (n= 16, 17, 32, 16)-3.6 ± 17.53.5 ± 17.82.1 ± 13.91.1 ± 23.0
Morning PEFR: Change at Week 2 (n= 16, 17, 32, 16)-5.0 ± 21.0-6.0 ± 18.6-1.3 ± 21.30.7 ± 27.2
Morning PEFR: Change at Week 3 (n= 15, 17, 31, 16)-8.8 ± 27.5-6.2 ± 17.81.9 ± 26.42.6 ± 22.4
Morning PEFR: Change at Week 4 (n= 15, 17, 31, 16)-5.9 ± 24.2-2.8 ± 18.43.3 ± 31.22.8 ± 28.9
Morning PEFR: Change at Week 5 (n= 15, 17, 30, 16)-13.4 ± 27.2-4.4 ± 21.5-9.4 ± 27.55.7 ± 31.0
Morning PEFR: Change at Week 6 (n= 15, 17, 30, 15)-10.5 ± 27.2-4.9 ± 21.0-3.9 ± 36.6-6.1 ± 26.8
Morning PEFR: Change at Week 7 (n= 15, 16, 29, 15)-8.3 ± 22.1-0.0 ± 24.31.2 ± 33.7-2.8 ± 26.7
Morning PEFR: Change at Week 8 (n= 15, 16, 27, 15)-9.5 ± 26.8-6.8 ± 29.40.4 ± 30.20.8 ± 23.1
Evening PEFR: Baseline (n= 16, 17, 32, 16)242.9 ± 111.8269.3 ± 123.1250.0 ± 78.7207.1 ± 88.2
Evening PEFR: Change at Week 1 (n= 16, 17, 32, 16)5.5 ± 20.5-0.2 ± 16.83.2 ± 19.75.2 ± 19.5
Evening PEFR: Change at Week 2 (n= 16, 17, 32, 16)4.8 ± 27.1-8.7 ± 19.60.4 ± 25.98.5 ± 37.8
Evening PEFR: Change at Week 3 (n= 15, 17, 31, 16)0.1 ± 16.2-17.0 ± 28.61.6 ± 22.97.6 ± 27.7
Evening PEFR: Change at Week 4 (n= 15, 17, 31, 16)-1.5 ± 21.5-13.7 ± 19.3-0.7 ± 23.61.6 ± 28.5
Evening PEFR: Change at Week 5 (n= 15, 17, 30, 16)-5.4 ± 23.6-14.2 ± 24.7-8.6 ± 27.09.5 ± 36.7
Evening PEFR: Change at Week 6 (n= 15, 17, 30, 15)-5.5 ± 26.8-13.6 ± 23.2-7.3 ± 27.7-4.5 ± 40.2
Evening PEFR: Change at Week 7 (n= 15, 16, 30, 15)0.8 ± 23.7-10.7 ± 21.6-6.0 ± 30.7-1.0 ± 34.5
Evening PEFR: Change at Week 8 (n= 15, 16, 28, 15)-2.6 ± 21.9-16.0 ± 23.4-3.4 ± 30.6-5.9 ± 41.9
Statistical analysis
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.7292 · Adjusted mean difference: -3.8
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.2768 · Adjusted mean difference: 3.7
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.3795 · Adjusted mean difference: 1.7
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.7374 · Adjusted mean difference: -4.9
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.7615 · Adjusted mean difference: -5.4
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.5811 · Adjusted mean difference: -1.4
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.8939 · Adjusted mean difference: -10.9
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.8117 · Adjusted mean difference: -7.5
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.4393 · Adjusted mean difference: 1.1
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.8055 · Adjusted mean difference: -8.5
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.6767 · Adjusted mean difference: -4.4
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.4070 · Adjusted mean difference: 2.0
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9705 · Adjusted mean difference: -18.6
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.8249 · Adjusted mean difference: -8.9
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.9345 · Adjusted mean difference: -12.7
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.7384 · Adjusted mean difference: -7.0
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.5239 · Adjusted mean difference: -0.6
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.4170 · Adjusted mean difference: 2.0
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.7695 · Adjusted mean difference: -7.6
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.4566 · Adjusted mean difference: 1.1
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.3535 · Adjusted mean difference: 3.3
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.8598 · Adjusted mean difference: -12.1
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.8005 · Adjusted mean difference: -9.2
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.3441 · Adjusted mean difference: 3.9
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.4436 · Adjusted mean difference: 1.0
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.7238 · Adjusted mean difference: -4.1
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.5743 · Adjusted mean difference: -1.1
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.6190 · Adjusted mean difference: -3.0
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.9473 · Adjusted mean difference: -15.9
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.8014 · Adjusted mean difference: -7.3
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.7929 · Adjusted mean difference: -7.1
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.9963 · Adjusted mean difference: -23.2
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.7387 · Adjusted mean difference: -4.8
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.6286 · Adjusted mean difference: -2.8
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.9538 · Adjusted mean difference: -14.1
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.5701 · Adjusted mean difference: -1.3
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.9242 · Adjusted mean difference: -14.5
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.9876 · Adjusted mean difference: -22.4
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.9802 · Adjusted mean difference: -18.1
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.5705 · Adjusted mean difference: -1.9
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.8063 · Adjusted mean difference: -9.0
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.6667 · Adjusted mean difference: -3.9
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.4640 · Adjusted mean difference: 0.9
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.8821 · Adjusted mean difference: -12.2
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.7591 · Adjusted mean difference: -6.4
  • UK-432,097 150 Mcg vs Placebo · Mixed Models Analysis · p = 0.4001 · Adjusted mean difference: 2.8
  • UK-432,097 450 Mcg vs Placebo · Mixed Models Analysis · p = 0.8707 · Adjusted mean difference: -12.3
  • UK-432,097 1350 Mcg vs Placebo · Mixed Models Analysis · p = 0.4629 · Adjusted mean difference: 0.9
SecondaryNumber of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)

CGI-C: clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.

Time frame:
Week 6
Reported as:
Number · participants
Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)
participantsUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Very Much Improved0001
Much Improved0222
Minimally Improved5494
No Change57146
Minimally Worse2342
Much Worse2000
Very Much Worse0000
Statistical analysis
  • UK-432,097 150 Mcg vs Placebo · Odds ratio (or): 0.6428 · 95% CI 0.2023 to 2.0419
  • UK-432,097 450 Mcg vs Placebo · Odds ratio (or): 0.5574 · 95% CI 0.1505 to 2.0647
  • UK-432,097 1350 Mcg vs Placebo · Odds ratio (or): 0.3270 · 95% CI 0.0830 to 1.2879
SecondaryNumber of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)

PGI-C: participant rated instrument to measure participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.

Time frame:
Week 6
Reported as:
Number · participants
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
participantsUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Very Much Improved0000
Much Improved2232
Minimally Improved3476
No Change78155
Minimally Worse1122
Much Worse1010
Very Much Worse0110
Statistical analysis
  • UK-432,097 150 Mcg vs Placebo · Odds ratio (or): 0.5709 · 95% CI 0.1790 to 1.8204
  • UK-432,097 450 Mcg vs Placebo · Odds ratio (or): 0.6416 · 95% CI 0.1736 to 2.3715
  • UK-432,097 1350 Mcg vs Placebo · Odds ratio (or): 0.5877 · 95% CI 0.1516 to 2.2777
Other pre-specifiedChange From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6

Pulse rate: the number of pulsations noted in a peripheral artery per unit of time after participant rested supine for 5 minutes, reported as beats per minute (bpm).

Time frame:
Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4
Reported as:
Mean · bpm
Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6
bpmUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Baseline (n= 17, 18, 35, 17)68.6 ± 11.4575.2 ± 12.3773.7 ± 12.8374.2 ± 13.07
Change at Week 0, Post-Dose (n= 16, 18, 35, 17)-0.4 ± 6.862.5 ± 6.721.3 ± 7.630.3 ± 7.86
Change at Week 1, Pre-Dose (n= 15, 18, 33, 16)3.2 ± 7.974.7 ± 10.970.8 ± 9.95-0.3 ± 10.10
Change at Week 1, Post-Dose (n= 17, 15, 32, 16)2.7 ± 10.102.2 ± 7.471.1 ± 8.910.5 ± 10.47
Change at Week 2, Post-Dose (n= 16, 17, 30, 16)1.6 ± 9.04-1.7 ± 10.802.7 ± 12.390.1 ± 6.97
Change at Week 4, Post-Dose (n= 15, 15, 30, 16)2.5 ± 10.081.3 ± 10.153.8 ± 16.522.4 ± 7.73
Change at Week 6, Pre-Dose (n= 15, 16, 28, 15)0.7 ± 6.16-0.1 ± 6.700.9 ± 11.39-1.2 ± 6.57
Change at Week 6, Post-Dose (n= 14, 16, 28, 15)2.2 ± 8.23-0.2 ± 7.443.5 ± 12.851.2 ± 8.88
Other pre-specifiedChange From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6

BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). BP was measured by sphygmomanometer (manual or semi-automated) using appropriate-sized and calibrated cuff after participant rested in supine position for 5 minutes.

Time frame:
Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4
Reported as:
Mean · millimeter of mercury (mmHg)
Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6
millimeter of mercury (mmHg)UK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
SBP: Baseline (n= 17, 18, 35, 17)128.5 ± 11.73137.3 ± 14.40129.5 ± 12.77132.7 ± 13.45
SBP: Change at Week 0, Post-Dose (n= 16,18,35,17)2.4 ± 7.29-1.3 ± 11.52-1.3 ± 9.700.4 ± 7.36
SBP: Change at Week 1, Pre-Dose (n= 15,18,33,16)1.4 ± 6.33-1.4 ± 15.340.7 ± 12.320.3 ± 11.98
SBP: Change at Week 1, Post-Dose (n= 17,15,32,16)0.5 ± 9.90-5.5 ± 16.171.0 ± 15.41-4.5 ± 12.81
SBP: Change at Week 2, Post-Dose (n= 16,17,30,16)1.4 ± 16.252.8 ± 16.640.5 ± 13.06-2.2 ± 14.86
SBP: Change at Week 4, Post-Dose (n= 15,15,30,16)3.1 ± 6.27-4.7 ± 12.96-1.3 ± 14.56-5.8 ± 15.21
SBP: Change at Week 6, Pre-Dose (n= 15,16,28,15)3.6 ± 11.57-7.6 ± 15.19-1.5 ± 9.541.2 ± 10.81
SBP: Change at Week 6, Post-Dose (n= 14,16,28,15)-1.2 ± 10.14-7.5 ± 13.73-0.9 ± 8.77-0.9 ± 12.68
DBP: Baseline (n= 17, 18, 35, 17)76.9 ± 7.1878.5 ± 10.2974.3 ± 8.3076.5 ± 7.24
DBP: Change at Week 0, Post-Dose (n= 16,18,35,17)0.1 ± 5.97-2.0 ± 6.21-0.7 ± 6.300.6 ± 6.44
DBP: Change at Week 1, Pre-Dose (n= 15,18,33,16)1.1 ± 10.56-0.8 ± 6.18-0.1 ± 8.681.5 ± 6.23
DBP: Change at Week 1, Post-Dose (n= 17,15,32,16)-1.9 ± 9.86-2.1 ± 8.72-0.2 ± 8.95-1.0 ± 7.41
DBP: Change at Week 2, Post-Dose (n= 16,17,30,16)-0.6 ± 11.280.1 ± 7.96-0.5 ± 8.070.1 ± 7.64
DBP: Change at Week 4, Post-Dose (n= 15,15,30,16)-1.8 ± 7.53-4.5 ± 6.49-1.9 ± 8.10-1.2 ± 7.79
DBP: Change at Week 6, Pre-Dose (n= 15,16,28,15)-2.2 ± 6.28-3.9 ± 8.21-0.3 ± 6.740.7 ± 5.09
DBP: Change at Week 6, Post-Dose (n= 14,16,28,15)-5.2 ± 6.90-7.3 ± 7.88-2.8 ± 6.87-3.5 ± 8.27
Other pre-specifiedChange From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8

Standard 12-lead ECG was performed after participant has rested for at least 10 minutes in supine position. ECG intervals (Int) included PR Int (time between onset of atrial depolarization and onset of ventricular depolarization), QRS Int (represented ventricular depolarization), RR Int (time between 2 QRS complex), QT Int (time corresponding to the beginning of depolarization to repolarization of the ventricles), corrected QT (QTc) Int, QT Int corrected by Fridericia's formula (QTcF=QT divided by cube root of RR Int) and Bazett's formula (QTcB=QT divided by square root of RR Int).

Time frame:
Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)
Reported as:
Mean · milliseconds (msec)
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8
milliseconds (msec)UK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
RR: Baseline (n= 17,18,34,17)747.0 ± 351.66696.1 ± 357.91733.3 ± 281.12745.7 ± 362.90
RR: Change at Week 0, Post-Dose (n= 17,18,34,17)34.4 ± 174.39-63.7 ± 82.96-2.0 ± 100.92-6.1 ± 93.51
RR: Change at Week 1, Post-Dose (n= 17,17,31,16)45.8 ± 250.92-62.8 ± 82.177.3 ± 112.166.0 ± 113.17
RR: Change at Week 2, Post-Dose (n= 16,17,31,16)-18.5 ± 111.03-49.1 ± 131.1012.0 ± 120.00-78.6 ± 202.34
RR: Change at Week 4, Post-Dose (n= 15,17,28,16)98.1 ± 291.65-88.7 ± 194.50-6.6 ± 144.20-66.0 ± 196.32
RR: Change at Week 6, Pre-Dose (n= 14,16,28,15)-19.3 ± 72.80-32.3 ± 84.20-1.6 ± 101.00-24.6 ± 206.21
RR: Change at Week 6, Post-Dose (n= 15,16,27,15)-22.9 ± 109.20-43.7 ± 99.03-27.3 ± 124.20-34.9 ± 233.38
RR: Change at Week 8 (n= 17,18,31,17)-10.4 ± 85.52-36.4 ± 83.34-1.1 ± 185.33-19.3 ± 200.12
PR: Baseline (n= 17,18,35,17)165.6 ± 23.91165.0 ± 23.03171.2 ± 26.92172.8 ± 23.89
PR: Change at Week 0, Post-Dose (n= 17,18,35,17)-0.7 ± 6.85-1.3 ± 8.51-2.4 ± 8.590.8 ± 16.21
PR: Change at Week 1, Post-Dose (n= 17,17,32,16)2.0 ± 12.43-0.6 ± 13.792.0 ± 19.930.2 ± 22.78
PR: Change at Week 2, Post-Dose (n= 16,17,32,16)1.6 ± 14.301.1 ± 13.33-4.1 ± 11.346.4 ± 40.37
PR: Change at Week 4, Post-Dose (n= 15,17,29,16)2.8 ± 11.81-2.5 ± 11.936.5 ± 49.749.2 ± 37.48
PR: Change at Week 6, Pre-Dose (n= 14,16,29,15)-2.4 ± 10.112.4 ± 12.85-2.1 ± 10.590.2 ± 26.08
PR: Change at Week 6, Post-Dose (n= 15,16,28,15)-1.5 ± 14.851.9 ± 14.63-3.0 ± 13.564.4 ± 29.21
PR: Change at Week 8 (n= 17,18,32,17)-4.9 ± 16.05-2.2 ± 13.17-3.6 ± 13.71-0.4 ± 16.64
QRS: Baseline (n= 17,18,35,17)93.2 ± 10.5889.1 ± 11.4085.8 ± 26.1992.7 ± 14.93
QRS: Change at Week 0, Post-Dose (n= 17,18,35,17)-0.4 ± 4.490.9 ± 3.31-1.0 ± 5.52-2.1 ± 9.82
QRS: Change at Week 1, Post-Dose (n= 17,17,32,16)-1.7 ± 12.30-0.6 ± 5.70-1.7 ± 6.115.6 ± 28.56
QRS: Change at Week 2, Post-Dose (n= 16,17,32,16)-0.2 ± 6.922.3 ± 4.96-2.6 ± 8.15-4.6 ± 9.82
QRS: Change at Week 4, Post-Dose (n= 15,17,29,16)-0.2 ± 5.95-0.7 ± 9.40-0.9 ± 6.30-2.2 ± 12.45
QRS: Change at Week 6, Pre-Dose (n= 14,16,29,15)2.2 ± 5.30-1.4 ± 7.54-2.5 ± 7.37-4.2 ± 10.91
QRS: Change at Week 6, Post-Dose (n= 15,16,28,15)3.4 ± 6.00-1.4 ± 9.70-1.3 ± 5.94-4.3 ± 10.86
QRS: Change at Week 8 (n= 17,18,32,17)0.5 ± 5.580.8 ± 3.880.1 ± 8.09-4.0 ± 9.02
QT: Baseline (n= 17,18,35,17)387.9 ± 27.09384.0 ± 37.04371.9 ± 27.52381.7 ± 40.08
QT: Change at Week 0, Post-Dose (n= 17,18,35,17)3.2 ± 16.81-5.1 ± 10.905.6 ± 22.761.4 ± 22.92
QT: Change at Week 1, Post-Dose (n= 17,17,32,16)-1.8 ± 27.75-12.5 ± 16.616.4 ± 23.751.6 ± 29.10
QT: Change at Week 2, Post-Dose (n= 16,17,32,16)15.4 ± 66.03-5.1 ± 18.913.4 ± 28.342.0 ± 26.65
QT: Change at Week 4, Post-Dose (n= 15,17,29,16)0.2 ± 25.61-3.9 ± 19.916.5 ± 36.69-1.6 ± 29.41
QT: Change at Week 6, Pre-Dose (n= 14,16,29,15)6.6 ± 21.85-5.0 ± 16.066.3 ± 25.402.6 ± 22.65
QT: Change at Week 6, Post-Dose (n= 15,16,28,15)9.7 ± 30.00-3.6 ± 17.515.0 ± 30.173.4 ± 28.95
QT: Change at Week 8 (n= 17,18,32,17)5.3 ± 26.56-6.8 ± 20.0811.3 ± 23.65-0.5 ± 18.66
QTc: Baseline (n= 17,18,35,17)401.1 ± 22.91409.6 ± 20.70409.2 ± 25.92410.8 ± 20.63
QTc: Change at Week 0, Post-Dose (n= 17,18,35,17)6.9 ± 11.007.1 ± 14.017.1 ± 20.174.3 ± 14.15
QTc: Change at Week 1, Post-Dose (n= 17,17,32,16)-2.1 ± 22.79-0.0 ± 10.523.3 ± 23.463.5 ± 10.63
QTc: Change at Week 2, Post-Dose (n= 16,17,32,16)18.5 ± 58.274.8 ± 19.043.0 ± 21.775.8 ± 22.96
QTc: Change at Week 4, Post-Dose (n= 15,17,29,16)1.6 ± 20.585.5 ± 18.949.4 ± 26.133.8 ± 23.36
QTc: Change at Week 6, Pre-Dose (n= 14,16,29,15)12.4 ± 16.86-0.4 ± 9.688.5 ± 22.91-4.7 ± 16.79
QTc: Change at Week 6, Post-Dose (n= 15,16,28,15)15.0 ± 15.875.4 ± 16.9410.6 ± 24.11-1.6 ± 20.10
QTc: Change at Week 8 (n= 17,18,32,17)11.5 ± 23.830.1 ± 10.349.1 ± 25.30-8.8 ± 15.00
QTcB: Baseline (n= 17,18,35,17)405.7 ± 27.46417.2 ± 18.69412.0 ± 25.85413.6 ± 18.26
QTcB: Change at Week 0, Post-Dose (n= 17,18,35,17)6.7 ± 11.696.8 ± 12.567.2 ± 21.299.8 ± 14.48
QTcB: Change at Week 1, Post-Dose (n= 17,17,32,16)0.9 ± 16.06-0.3 ± 14.534.2 ± 24.277.8 ± 17.50
QTcB: Change at Week 2, Post-Dose (n= 16,17,32,16)17.9 ± 56.347.6 ± 16.394.1 ± 23.218.5 ± 18.05
QTcB: Change at Week 4, Post-Dose (n= 15,17,29,16)-0.7 ± 24.274.0 ± 13.9511.3 ± 29.549.2 ± 18.59
QTcB: Change at Week 6, Pre-Dose (n= 14,16,29,15)13.0 ± 14.92-1.0 ± 12.8110.0 ± 24.00-1.5 ± 12.18
QTcB: Change at Week 6, Post-Dose (n= 15,16,28,15)15.2 ± 13.763.8 ± 16.6913.9 ± 23.883.0 ± 11.68
QTcB: Change at Week 8 (n= 17,18,32,17)11.6 ± 24.91-1.2 ± 10.2110.7 ± 28.23-6.2 ± 13.54
QTcF: Baseline (n= 17,18,35,17)399.4 ± 22.33405.4 ± 22.06397.8 ± 20.90402.3 ± 20.33
QTcF: Change at Week 0, Post-Dose (n= 17,18,35,17)5.5 ± 10.292.8 ± 9.306.7 ± 19.106.8 ± 15.06
QTcF: Change at Week 1, Post-Dose (n= 17,17,32,16)-0.1 ± 16.61-4.5 ± 12.735.2 ± 20.605.4 ± 15.26
QTcF: Change at Week 2, Post-Dose (n= 16,17,32,16)16.9 ± 58.633.1 ± 11.214.1 ± 20.596.2 ± 18.85
QTcF: Change at Week 4, Post-Dose (n= 15,17,29,16)-0.4 ± 21.211.3 ± 12.149.4 ± 27.885.6 ± 20.76
QTcF: Change at Week 6, Pre-Dose (n= 14,16,29,15)10.9 ± 16.11-2.4 ± 9.758.8 ± 20.37-0.0 ± 13.67
QTcF: Change at Week 6, Post-Dose (n= 15,16,28,15)13.2 ± 17.111.3 ± 14.1510.9 ± 22.533.1 ± 14.58
QTcF: Change at Week 8 (n= 17,18,32,17)9.4 ± 24.35-3.0 ± 10.3810.9 ± 23.31-4.3 ± 10.00
Other pre-specifiedChange From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8

Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.

Time frame:
Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)
Reported as:
Mean · bpm
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8
bpmUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
Baseline (n= 17,18,35,17)66.6 ± 11.6572.1 ± 11.0074.8 ± 12.9272.4 ± 13.81
Change at Week 0, Post-Dose (n= 17,18,35,17)0.8 ± 6.564.0 ± 5.900.3 ± 8.692.7 ± 7.76
Change at Week 1, Post-Dose (n= 17,17,32,16)1.1 ± 9.764.3 ± 6.30-1.5 ± 10.132.8 ± 13.45
Change at Week 2, Post-Dose (n= 16,17,32,16)0.7 ± 8.984.2 ± 10.38-0.2 ± 12.761.9 ± 8.06
Change at Week 4, Post-Dose (n= 15,17,29,16)-0.2 ± 8.752.4 ± 8.332.5 ± 18.513.2 ± 8.23
Change at Week 6, Pre-Dose (n= 14,16,29,15)2.3 ± 5.171.4 ± 7.710.6 ± 11.82-1.7 ± 7.72
Change at Week 6, Post-Dose (n= 15,16,28,15)1.9 ± 8.682.2 ± 6.942.6 ± 11.840.3 ± 11.31
Change at Week 8 (n= 17,18,32,17)1.9 ± 5.941.8 ± 6.51-0.8 ± 11.16-2.1 ± 9.57
Other pre-specifiedChange in Post-Study Drug Forced Expiratory Volume in 1 Second (FEV1) Compared to Pre-Study Drug Forced Expiratory Volume in 1 Second (FEV1) at Week 0, 1, 2, 4, and 6

FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration. Pre-study drug FEV1 was obtained from spirometry, performed before study treatment administration.

Time frame:
Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
UK-432,097 150 Mcg—0/17 (0%)11/17 (64.7%)
UK-432,097 450 Mcg—0/18 (0%)8/18 (44.4%)
UK-432,097 1350 Mcg—0/35 (0%)11/35 (31.4%)
Placebo—0/17 (0%)10/17 (58.8%)
Most frequent other events
Showing 10 of 40
Most frequent other events
EventUK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlacebo
NasopharyngitisInfections and infestations1/173/183/351/17
Chest painGeneral disorders2/170/180/350/17
Blood alkaline phosphatase increasedInvestigations2/170/180/350/17
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders2/170/182/350/17
Infective exacerbation of chronic obstructive airways diseaseInfections and infestations0/172/182/350/17
DyspnoeaRespiratory, thoracic and mediastinal disorders1/172/180/350/17
Atrioventricular block first degreeCardiac disorders0/170/180/351/17
Vision blurredEye disorders0/170/180/351/17
NauseaGastrointestinal disorders0/170/180/351/17
VomitingGastrointestinal disorders0/170/180/351/17

Baseline characteristics

Age, Customized
Age, Customized(participants)UK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlaceboTotal
45 to 64 Years8712936
Greater Than or Equal to (>=) 65 Years91123851
Sex: Female, Male
Sex: Female, Male(Participants)UK-432,097 150 McgUK-432,097 450 McgUK-432,097 1350 McgPlaceboTotal
Female559625
Male1213261162
08

Study locations

22 sites
  • Pfizer Investigational Site
    Camperdown, New South Wales 2050, Australia
  • Pfizer Investigational Site
    Glebe, New South Wales 2037, Australia
  • Pfizer Investigational Site
    Daw Park, South Australia 5041, Australia
  • Pfizer Investigational Site
    Nedlands, Western Australia 6009, Australia
  • Pfizer Investigational Site
    Calgary, Alberta T1Y 6J4, Canada
  • Pfizer Investigational Site
    Red Deer, Alberta T4N 6V7, Canada
  • Pfizer Investigational Site
    Hamilton, Ontario L8N 3Z5, Canada
  • Pfizer Investigational Site
    Québec, Quebec G1V 4G5, Canada
  • Pfizer Investigational Site
    Trois-Rivières, Quebec G8T 7A1, Canada
  • Pfizer Investigational Site
    Almelo, 7609 PP, Netherlands
  • Pfizer Investigational Site
    Eindhoven, 5623 EJ, Netherlands
  • Pfizer Investigational Site
    Zuthpen, 7207 BA, Netherlands
  • Pfizer Investigational Site
    Bydgoszcz, 85-326, Poland
  • Pfizer Investigational Site
    Gdansk, 80-952, Poland
  • Pfizer Investigational Site
    Lodz, 90-153, Poland
  • Pfizer Investigational Site
    Warszawa, 01-138, Poland
  • Pfizer Investigational Site
    Chertsey, Surrey KT16 0PZ, United Kingdom
  • Pfizer Investigational Site
    Leicester, LE3 9QP, United Kingdom
  • Pfizer Investigational Site
    London, E2 9ZY, United Kingdom
  • Pfizer Investigational Site
    Manchester, M23 QZ, United Kingdom
  • Pfizer Investigational Site
    Newcastle upon Tyne, NE7 7DN, United Kingdom
  • Pfizer Investigational Site
    Southampton, SO16 6YD, United Kingdom
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00430300
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Feb 1, 2007
Start date
Jan 2007
Primary completion
Jul 2008
Completion
Jul 2008
Results posted
Jul 8, 2013
Last update
Jul 8, 2013

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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