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CompletedNCT01078623ALIGHT-COPDUpdated Feb 23, 2017Results posted

Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate

A Phase 2 interventional study of Aclidinium 200 μg / formoterol 12 μg and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by AstraZeneca. Completed at 10 sites in 2 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
176
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD.

Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • Bronchitis
  • Chronic
  • Emphysema
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 176 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) 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

  1. Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive.
  2. Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification
  3. Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.
  4. Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is 30% FEV1 \<80% of the predicted normal value (i.e., 100 x Post-salbutamol \< FEV1/ Predicted FEV1 must be \< 80% and ≥ 30%).
  5. Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is \< 70% (i.e., 100 x Post-salbutamol FEV1 /FVC \< 70%).
  6. Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.
  7. Patient whose COPD symptoms and FEV1 values at the time of randomisation are stable compared to the Screening Visit, according to the investigator's medical judgment

Exclusion criteria

Exclusion Criteria:

  1. History or current diagnosis of asthma or exercise-induced bronchospasm.
  2. Clinically significant respiratory conditions at the time of Inform Consent signature
  3. Hospitalisation due to COPD exacerbation within the previous 3 months.
  4. Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.
  5. Patient who has a resting systolic blood pressure ≥ 200 mmHg, a resting diastolic blood pressure ≥ 120 mmHg or a resting heart rate ≥ 105 bpm at screening visit.
  6. Clinically significant cardiovascular conditions
  7. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
  8. Presence of narrow-angle glaucoma.
  9. QTc [calculated according to Bazett's formulae (QTc=QT/RR1/2) above 470 milliseconds in the ECG performed at Screening Visit,
  10. Patient who does not maintain regular day/night, waking/sleeping cycles
05

Study design

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

Study arms

  • Active comparator
    Formoterol 12 μg

    Formoterol fumarate 12 μg twice daily

    Drug: Formoterol 12 μg

  • Placebo comparator
    Placebo

    Placebo twice daily

    Drug: Placebo

  • Experimental
    Aclidinium 200 μg / formoterol 12 μg

    Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily

    Drug: Aclidinium 200 μg / formoterol 12 μg

  • Experimental
    Aclidinium 200 μg / formoterol 6 μg

    Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily

    Drug: Aclidinium 200 μg / Formoterol 6 μg

  • Experimental
    Aclidinium 200 μg

    Aclidinium bromide 200 μg twice daily

    Drug: Aclidinium 200 μg

Interventions

  • DrugAclidinium 200 μg / formoterol 12 μg

    Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily

  • DrugPlacebo

    Placebo control twice daily

  • DrugFormoterol 12 μg

    Formoterol fumarate 12 μg twice daily

  • DrugAclidinium 200 μg

    Aclidinium bromide 200 μg twice daily

  • DrugAclidinium 200 μg / Formoterol 6 μg

    Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14

    FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose

    Time frame: 0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14

Secondary outcomes

  1. Change From Baseline in Morning Pre-dose FEV1 at Day 14

    FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes

    Time frame: Day 14

  2. Change From Baseline in Morning Peak FEV1 at Day 14

    FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose

    Time frame: 0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14

07

Results

Posted Nov 15, 2016

Participant flow

This study was conducted at a total of 28 sites (4 sites in Czech Republic, 5 sites in Germany, 3 sites in Hungary, 4 sites in Poland and 12 sites in Romania) The first patient was screened in February 2010 and the last patient visit was in September 2010

Treatment Period 1
Participant flow — Treatment Period 1
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Sequence 7Sequence 8Sequence 9Sequence 10Sequence 11Sequence 12Sequence 13Sequence 14Sequence 15Sequence 16Sequence 17Sequence 18Sequence 19Sequence 20
Started66767677677777777777
Completed55667566566777777777
Not completed11100111111000000000
Withdrew: Adverse event11100010110000000000
Withdrew: Withdrawal by subject00000001001000000000
Withdrew: Protocol violation00000100000000000000
Treatment Period 2
Participant flow — Treatment Period 2
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Sequence 7Sequence 8Sequence 9Sequence 10Sequence 11Sequence 12Sequence 13Sequence 14Sequence 15Sequence 16Sequence 17Sequence 18Sequence 19Sequence 20
Started55667566566777777777
Completed55667456566777777767
Not completed00000110000000000010
Withdrew: Adverse event00000010000000000010
Withdrew: Withdrawal by subject00000100000000000000
Treatment Period 3
Participant flow — Treatment Period 3
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Sequence 7Sequence 8Sequence 9Sequence 10Sequence 11Sequence 12Sequence 13Sequence 14Sequence 15Sequence 16Sequence 17Sequence 18Sequence 19Sequence 20
Started55667456566777777767
Completed55666456566776777767
Not completed00001000000001000000
Withdrew: Adverse event00001000000001000000
Treatment Period 4
Participant flow — Treatment Period 4
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Sequence 7Sequence 8Sequence 9Sequence 10Sequence 11Sequence 12Sequence 13Sequence 14Sequence 15Sequence 16Sequence 17Sequence 18Sequence 19Sequence 20
Started55666456566776777767
Completed55566456566776767767
Not completed00100000000000010000
Withdrew: Adverse event00100000000000000000
Withdrew: Withdrawal by subject00000000000000010000

Outcome measures

PrimaryChange From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14

FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose

Time frame:
0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14
Reported as:
Least squares mean · Liters
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14
LitersPlaceboAclidinium 200 μg / Formoterol 12 μgAclidinium 200 μg / Formoterol 6 μgAclidinium 200 μgFormoterol 12 μg
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14-0.041 ± 0.0210.180 ± 0.0210.193 ± 0.0210.139 ± 0.0210.100 ± 0.021
Statistical analysis
  • Placebo vs Aclidinium 200 μg / Formoterol 12 μg · Mixed Models Analysis · p = <0.0001 · Least squares mean difference: 0.221 · 95% CI 0.174 to 0.268Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate
  • Placebo vs Aclidinium 200 μg / Formoterol 6 μg · Mixed Models Analysis · p = <0.0001 · Least squares mean difference: 0.234 · 95% CI 0.186 to 0.281Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate
SecondaryChange From Baseline in Morning Pre-dose FEV1 at Day 14

FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes

Time frame:
Day 14
Reported as:
Least squares mean · Liters
Change From Baseline in Morning Pre-dose FEV1 at Day 14
LitersPlaceboAclidinium 200 μg / Formoterol 12 μgAclidinium 200 μg / Formoterol 6 μgAclidinium 200 μgFormoterol 12 μg
Change From Baseline in Morning Pre-dose FEV1 at Day 14-0.059 ± 0.0200.042 ± 0.0200.067 ± 0.0200.072 ± 0.0200.027 ± 0.020
SecondaryChange From Baseline in Morning Peak FEV1 at Day 14

FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose

Time frame:
0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14
Reported as:
Least squares mean · Liters
Change From Baseline in Morning Peak FEV1 at Day 14
LitersPlaceboAclidinium 200 μg / Formoterol 12 μgAclidinium 200 μg / Formoterol 6 μgAclidinium 200 μgFormoterol 12 μg
Change From Baseline in Morning Peak FEV1 at Day 140.052 ± 0.0230.335 ± 0.0230.347 ± 0.0230.255 ± 0.0230.255 ± 0.023

Adverse events

Collected over Up to 14 days following last dose of the investigational medicinal product (given over 14±2 days of treatment per period, with 4 treatment periods per patient). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/101 (0%)0/101 (0%)
Aclidinium 200 μg / Formoterol 12 μg—2/101 (2%)0/101 (0%)
Aclidinium 200 μg / Formoterol 6 μg—0/102 (0%)0/102 (0%)
Aclidinium 200 μg—0/100 (0%)0/100 (0%)
Formoterol 12 μg—1/101 (1%)0/101 (0%)
Most frequent serious events
Most frequent serious events
EventPlaceboAclidinium 200 μg / Formoterol 12 μgAclidinium 200 μg / Formoterol 6 μgAclidinium 200 μgFormoterol 12 μg
Pulmonary massRespiratory, thoracic and mediastinal disorders0/1011/1010/1020/1000/101
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders0/1011/1010/1020/1000/101
Ventricular tachycardiaCardiac disorders0/1010/1010/1020/1001/101

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Overall Study Population
Mean60.4 ± 7.93
Gender
Gender(Participants)Overall Study Population
Female40
Male95
08

Study locations

10 sites
  • Research Site
    Bucuresti, Czech Republic
  • Research Site
    Constanta, Czech Republic
  • Research Site
    Iasi, Czech Republic
  • Research Site
    Tg Mures, Czech Republic
  • Research Site
    Bucuresti, Romania
  • Research Site
    Cluj Napoca, Romania
  • Research Site
    Deva, Romania
  • Research Site
    Iasi, Romania
  • Research Site
    Oradea, Romania
  • Research Site
    Timisoara, Romania
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01078623
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Mar 2, 2010
Start date
Feb 2010
Primary completion
Sep 2010
Completion
Sep 2010
Results posted
Nov 15, 2016
Last update
Feb 23, 2017

Study contacts

Esther Garcia, MD
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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