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CompletedNCT00928668Updated Jul 1, 2014Results posted

Efficacy (Bronchoprotection) and Safety of Orally Inhaled BI 1744 CL in Patients With Intermittent Asthma

A Phase 2 interventional study of Placebo and Olodaterol (BI1744CL) in Asthma, sponsored by Boehringer Ingelheim. Completed at 4 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-01.

Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of this study is to assess the efficacy (bronchoprotection) and safety of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the Respimat® inhaler, in patients with intermittent asthma.

02

Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 32 is below the median of 83 across 2,751 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosis of intermittent asthma according to Global Initiative for Asthma criteria
  2. Non-smokers or ex-smokers who have not smoked for at least 1 year and have a smoking history of less than 5 pack-years
  3. Forced Expiratory Volume in 1second greater than or equal to 80% predicted normal (Visit 1).
  4. Bronchial hyperresponsiveness to inhaled methacholine with a provocative concentration of a methacholine causing a 20% fall in Forced Expiratory Volume in one second less than or equal to 8 mg/mL (Visit 1).
  5. Be able to perform technically acceptable pulmonary function tests
  6. Be able to inhale medication in a competent manner from the Respimat® inhaler
  7. Must sign and date an informed consent consistent with International Conference on Harmonisation-Good Clinical Practice guidelines prior to participation in the trial, which includes medication washout and restrictions.

Exclusion criteria

Exclusion criteria

  1. Patients with a significant disease other than asthma
  2. Patients with seasonal asthma or allergies whose participation in the trial will occur during the season for which they are allergic.
  3. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with a serum glutamic oxaloacetic transaminase > 80 IU/L, serum glutamic pyruvic transaminase > 80 IU/L, bilirubin >2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition
  4. Patients with any of the following conditions: a diagnosis of hyperthyrosis or paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of QT/QTc interval, a history of additional risk factors for Torsade de Pointes, a history of myocardial infarction, a diagnosis of clinically relevant cardiac arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years (patients with treated basal cell carcinoma are allowed), a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, or a history of significant alcohol or drug abuse.
  5. Patients who have undergone thoracotomy with pulmonary resection
  6. Patients who are being treated with any of the following concomitant medications: medications that prolong the QT/QTc interval, oral beta-adrenergics, beta-blockers or monoamine oxidase inhibitors or tricyclic antidepressants.
  7. Patients who have been treated with any respiratory medications (excluding short-acting beta-agonists) for control of their asthma symptoms within 3 months of the Screening Visit (Visit 1).
  8. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1).
  9. Pregnant or nursing women, or women of childbearing potential not using a highly effective method of birth control.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Olodaterol (BI1744) Low

    Single dosing of low dose Olodaterol inhaled orally from Respimat Device

    Drug: Olodaterol (BI1744CL)

  • Experimental
    Olodaterol (BI1744) Medium Low

    Single dosing of medium low dose Olodaterol inhaled orally from Respimat Device

    Drug: Olodaterol (BI1744CL)

  • Experimental
    Olodaterol (BI1744) Medium High

    Single dosing of medium high dose Olodaterol inhaled orally from Respimat Device

    Drug: Olodaterol (BI1744CL)

  • Experimental
    Olodaterol (BI 1744) High

    Single dosing of high dose Olodaterol inhaled orally from Respimat Device

    Drug: Olodaterol (BI1744CL)

  • Placebo comparator
    Placebo

    Single dosing of Olodaterol placebo inhaled orally from Respimat Device

    Drug: Placebo

Interventions

  • DrugPlacebo

    Placebo device for comparison

  • DrugOlodaterol (BI1744CL)

    Olodaterol comparison of low, medium low, medium high and high doses

  • DrugOlodaterol (BI1744CL)

    Olodaterol comparison of low, medium low, medium high and high doses

  • DrugOlodaterol (BI1744CL)

    Olodaterol comparison of low, medium low, medium high and high doses

  • DrugOlodaterol (BI1744CL)

    Olodaterol comparison of low, medium low, medium high and high doses

06

What researchers measure

Primary outcomes

  1. Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours

    Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours

    Time frame: 24 hours post dose

Secondary outcomes

  1. Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes

    Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes

    Time frame: 30 minutes post dose

  2. Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours

    Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours

    Time frame: 4 hours post dose

  3. Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours

    Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours

    Time frame: 8 hours post dose

  4. Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours

    Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours

    Time frame: 32 hours post dose

  5. Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG

    Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).

    Time frame: 5 days

  6. Laboratory Testing: Average Change From Baseline of Potassium and Calcium

    Laboratory testing: Average change from baseline of potassium and calcium measured on test-days

    Time frame: Baseline to Visit 6

07

Results

Posted Jul 1, 2014

Participant flow

This was a randomised, double-blind, placebo-controlled, 5-way crossover trial. The duration of each treatment period was 1 day with a 14 day washout period between treatments.

Participant flow — Overall Study
MilestoneOlo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcgOlo 10mcg / Olo 20mcg / Olo 2mcg / Olo 5mcg / PlaceboOlo 2mcg / Placebo / Olo 20mcg / Olo 10mcg / Olo 5mcgOlo 20mcg / Olo 5mcg / Placebo / Olo 2mcg / Olo 10mcgPlacebo / Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg
Started77746
Completed66635
Not completed11111
Withdrew: Adverse event10000
Withdrew: Protocol violation00001
Withdrew: Withdrawal by subject01100
Withdrew: Other reasons not listed above00010

Outcome measures

PrimaryAdjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours

Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours

Time frame:
24 hours post dose
Reported as:
Least squares mean · Log base 2 (mg/ml)
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours
Log base 2 (mg/ml)PlaceboOlodaterol (Olo) 2 mcg qdOlodaterol (Olo) 5 mcg qdOlodaterol (Olo) 10 mcg qdOlodaterol (Olo) 20 mcg qd
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours0.793 ± 0.1821.950 ± 0.1862.504 ± 0.1903.236 ± 0.1793.777 ± 0.183
Statistical analysis
  • Placebo vs Olodaterol (Olo) 2 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 1.157 · 95% CI 0.657 to 1.657Olo 2 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 5 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 1.711 · 95% CI 1.205 to 2.217Olo 5 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 10 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 2.443 · 95% CI 1.952 to 2.935Olo 10 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 20 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 2.984 · 95% CI 2.486 to 3.483Form 20 mcg minus Placebo
SecondaryAdjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes

Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes

Time frame:
30 minutes post dose
Reported as:
Least squares mean · Log base 2 (mg/ml)
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes
Log base 2 (mg/ml)PlaceboOlodaterol (Olo) 2 mcg qdOlodaterol (Olo) 5 mcg qdOlodaterol (Olo) 10 mcg qdOlodaterol (Olo) 20 mcg qd
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes0.393 ± 0.1802.532 ± 0.1843.029 ± 0.1873.953 ± 0.1774.617 ± 0.181
Statistical analysis
  • Placebo vs Olodaterol (Olo) 2 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 2.139 · 95% CI 1.645 to 2.633Olo 2 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 5 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 2.636 · 95% CI 2.135 to 3.136Olo 5 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 10 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 3.560 · 95% CI 3.074 to 4.046Olo 10 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 20 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 4.224 · 95% CI 3.731 to 4.717Form 20 mcg minus Placebo
SecondaryAdjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours

Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours

Time frame:
4 hours post dose
Reported as:
Least squares mean · Log base 2 (mg/ml)
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours
Log base 2 (mg/ml)PlaceboOlodaterol (Olo) 2 mcg qdOlodaterol (Olo) 5 mcg qdOlodaterol (Olo) 10 mcg qdOlodaterol (Olo) 20 mcg qd
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours0.577 ± 0.2142.602 ± 0.2192.957 ± 0.2234.126 ± 0.2114.786 ± 0.215
Statistical analysis
  • Placebo vs Olodaterol (Olo) 2 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 2.025 · 95% CI 1.437 to 2.613Olo 2 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 5 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 2.380 · 95% CI 1.785 to 2.975Olo 5 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 10 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 3.549 · 95% CI 2.971 to 4.127Olo 10 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 20 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 4.208 · 95% CI 3.622 to 4.794Form 20 mcg minus Placebo
SecondaryAdjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours

Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours

Time frame:
8 hours post dose
Reported as:
Least squares mean · Log base 2 (mg/ml)
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours
Log base 2 (mg/ml)PlaceboOlodaterol (Olo) 2 mcg qdOlodaterol (Olo) 5 mcg qdOlodaterol (Olo) 10 mcg qdOlodaterol (Olo) 20 mcg qd
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours0.576 ± 0.2132.484 ± 0.2183.050 ± 0.2223.903 ± 0.2104.796 ± 0.214
Statistical analysis
  • Placebo vs Olodaterol (Olo) 2 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 1.907 · 95% CI 1.322 to 2.492Olo 2 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 5 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 2.474 · 95% CI 1.822 to 3.066Olo 5 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 10 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 3.327 · 95% CI 2.752 to 3.902Olo 10 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 20 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 4.220 · 95% CI 3.637 to 4.803Form 20 mcg minus Placebo
SecondaryAdjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours

Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours

Time frame:
32 hours post dose
Reported as:
Least squares mean · Log base 2 (mg/ml)
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours
Log base 2 (mg/ml)PlaceboOlodaterol (Olo) 2 mcg qdOlodaterol (Olo) 5 mcg qdOlodaterol (Olo) 10 mcg qdOlodaterol (Olo) 20 mcg qd
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours0.960 ± 0.2002.189 ± 0.2002.785 ± 0.2033.074 ± 0.1923.605 ± 0.197
Statistical analysis
  • Placebo vs Olodaterol (Olo) 2 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 1.229 · 95% CI 0.692 to 1.766Olo 2 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 5 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 1.825 · 95% CI 1.281 to 2.369Olo 5 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 10 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 2.114 · 95% CI 1.578 to 2.650Olo 10 mcg minus Placebo
  • Placebo vs Olodaterol (Olo) 20 mcg qd · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 2.645 · 95% CI 2.110 to 3.181Form 20 mcg minus Placebo
SecondaryClinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG

Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).

Time frame:
5 days
Reported as:
Number · percentage of participants
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
percentage of participantsPlaceboOlo 2 mcgOlo 5 mcgOlo 10 mcgOlo 20 mcg
Cardiac disorders00000
Investigations00000
SecondaryLaboratory Testing: Average Change From Baseline of Potassium and Calcium

Laboratory testing: Average change from baseline of potassium and calcium measured on test-days

Time frame:
Baseline to Visit 6
Reported as:
Geometric mean · mmol/L
Laboratory Testing: Average Change From Baseline of Potassium and Calcium
mmol/LPlaceboOlodaterol (Olo) 2 mcg qdOlodaterol (Olo) 5 mcg qdOlodaterol (Olo) 10 mcg qdOlodaterol (Olo) 20 mcg qd
Potassium1.01 ± NA1.04 ± NA1.02 ± NA1.00 ± NA0.98 ± NA
Calcium1.00 ± NA1.01 ± NA1.00 ± NA1.00 ± NA1.01 ± NA

Adverse events

Collected over 2 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/29 (0%)4/29 (13.8%)
Olo 2 mcg—0/28 (0%)1/28 (3.6%)
Olo 5 mcg—0/28 (0%)1/28 (3.6%)
Olo 10 mcg—0/30 (0%)1/30 (3.3%)
Olo 20 mcg—0/29 (0%)4/29 (13.8%)
Most frequent other events
Most frequent other events
EventPlaceboOlo 2 mcgOlo 5 mcgOlo 10 mcgOlo 20 mcg
HeadacheNervous system disorders3/290/280/280/302/29
CoughRespiratory, thoracic and mediastinal disorders1/291/281/281/302/29

Baseline characteristics

Age, Continuous
Age, Continuous(years)Study Total
Mean28.9 ± 9.2
Sex: Female, Male
Sex: Female, Male(Participants)Study Total
Female17
Male14
08

Study locations

4 sites
  • 1222.4.103 UBC - Respiratory Medicine
    Vancouver, British Columbia, Canada
  • 1222.4.104 Department of Medicine, Health Sciences Centre
    Hamilton, Ontario, Canada
  • 1222.4.101 2725 Chemin Ste Foy
    Sainte-Foy, Quebec, Canada
  • 1222.4.102
    Saskatoon, Saskatchewan, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00928668
Lead sponsor
Boehringer Ingelheim
First posted
Jun 26, 2009
Start date
Jan 2006
Primary completion
Oct 2006
Results posted
Jul 1, 2014
Last update
Jul 1, 2014

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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