Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00932646
First received: July 2, 2009
Last updated: May 27, 2014
Last verified: May 2014

July 2, 2009
May 27, 2014
June 2009
May 2010   (final data collection date for primary outcome measure)
  • FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment [ Time Frame: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
  • FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment [ Time Frame: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
The primary objective will be to evaluate whether once daily treatment with 5 mcg or 10 mcg BI 1744 administered via the Respimat device is superior to once daily treatment with Placebo Respimat using FEV1 AUC values [ Time Frame: 6 Weeks ]
Complete list of historical versions of study NCT00932646 on ClinicalTrials.gov Archive Site
  • Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment [ Time Frame: 1 h and 10 min prior to am dose on the first day of the treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment. ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.
  • Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to am dose after six weeks of treatment ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.
  • Peak FEV1 (0-3h) Response [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak values were obtained within 0 - 3 hours after the last am dose after six weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.
  • Trough FEV1 Response [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.
  • Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response [ Time Frame: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
  • FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response [ Time Frame: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
  • FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response [ Time Frame: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment. ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
  • Peak FVC (0-3h) Response [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.
  • Trough FVC Response [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.
  • Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 related to treatment (cardiac disorders and investigations).
The key secondary objective will be to compare once daily treatment with 5 mcg or 10 mcg BI 1744 administered via the Respimat device to twice daily treatment with Foradil Aerolizer using FEV1 AUC values. Additional pulmonary and safety measures [ Time Frame: 6 Weeks ]
Not Provided
Not Provided
 
Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: BI 1744 (Olodaterol) Low Dose
    BI1744 Respimat low dose once daily and placebo Foradil
  • Drug: BI 1744 (Olodaterol) Medium Dose
    BI1744 Respimat medium dose once daily and placebo Foradil
  • Drug: Placebo
    Placebo Respimat once daily and placebo Foradil
  • Drug: Foradil
    12 mcg twice daily and placebo Respimat
  • Experimental: BI1744 (Olodaterol)
    Medium Dose once Daily
    Intervention: Drug: BI 1744 (Olodaterol) Medium Dose
  • Experimental: BI 1744 (Olodaterol)
    Low Dose once Daily
    Intervention: Drug: BI 1744 (Olodaterol) Low Dose
  • Placebo Comparator: Placebo
    Placebo once Daily
    Intervention: Drug: Placebo
  • Active Comparator: Foradil
    12 mcg twice daily
    Intervention: Drug: Foradil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Not Provided
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients willing to participate with confirmed diagnosis of COPD
  • 40 years of age or older
  • having a 10 pack year smoking history
  • able to perform serial pulmonary function tests
  • able to use both a DPI and Respimat device

Exclusion Criteria:

Significant other disease

  • clinically relevant abnormal hematology, chemistry, or urinalysis
  • history of asthma
  • diagnosis of thyrotoxicosis
  • paroxysmal tachycardia related to beta agonists
  • history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
  • active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
  • significant alcohol or drug use
  • pulmonary resection
  • taking oral beta adrenergics
  • taking unstable oral steroids
  • daytime oxygen
  • enrolled in rehabilitation program
  • enrolled in another study or taking investigational products
  • pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
  • those who are not willing to comply with pulmonary medication washouts
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00932646
1222.25
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP