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Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00931385
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : July 1, 2014
Last Update Posted : July 1, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE July 1, 2009
First Posted Date  ICMJE July 2, 2009
Results First Submitted Date  ICMJE March 28, 2014
Results First Posted Date  ICMJE July 1, 2014
Last Update Posted Date July 1, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
  • 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 ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
  • 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 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. ]
    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 the last am dose after six weeks of treatment ]
    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 ]
    Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values at the randomisation visit. Peak (0-3h) 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 ]
    Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough 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 ]
    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 ]
    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. ]
    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 ]
    Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values at the randomisation visit. Peak FVC (0-3h) 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 ]
    Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough 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 ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
Official Title  ICMJE Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil Iin Patients With Chronic Obstructive Pulmonary Disease
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: BI 1744
    BI1744 Respimat Med Dose Once Daily
  • Drug: bi1744
    1744 low dose
  • Drug: Placebo
    Placebo Respimat and Foradil Placebo
  • Drug: Foradil
    Foradil 12 mcg twice daily and Placebo Respimat
Study Arms  ICMJE
  • Experimental: BI 1744 (Olodaterol) Low Dose
    BI1744 Low Dose once daily
    Intervention: Drug: bi1744
  • Experimental: BI 1744 (Olodaterol) Med Dose
    BI 1744 Med Dose once daily
    Intervention: Drug: BI 1744
  • Placebo Comparator: Placebo
    Placebo once daily
    Intervention: Drug: Placebo
  • Active Comparator: Foradil
    Foradil 12 mcg twice daily
    Intervention: Drug: Foradil
Publications * Feldman GJ, Bernstein JA, Hamilton A, Nivens MC, Korducki L, LaForce C. The 24-h FEV1 time profile of olodaterol once daily via Respimat® and formoterol twice daily via Aerolizer® in patients with GOLD 2-4 COPD: results from two 6-week crossover studies. Springerplus. 2014 Aug 9;3:419. doi: 10.1186/2193-1801-3-419. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2010)
99
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2009)
100
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00931385
Other Study ID Numbers  ICMJE 1222.24
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date May 2014

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