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
Results First Received: March 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: BI 1744 (Olodaterol) Low Dose
Drug: BI 1744 (Olodaterol) Medium Dose
Drug: Placebo
Drug: Foradil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.

Reporting Groups
  Description
Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Foradil 12 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg Patients were administered Olodaterol 5mcg qd in the first period, Foradil 12 mcg bid in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Foradil 12 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo Patients were administered Foradil 12 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.

Participant Flow:   Overall Study
    Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg     Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg     Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg     Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo  
STARTED     25     25     25     25  
COMPLETED     20     22     21     24  
NOT COMPLETED     5     3     4     1  
Adverse Event                 2                 1                 1                 1  
Lost to Follow-up                 2                 1                 0                 0  
Withdrawal by Subject                 1                 1                 3                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set, i.e. all treated patients.

Reporting Groups
  Description
Study Total Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 99 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo delivered by Respimat Inhaler or Aerolizer Inhaler. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.

Baseline Measures
    Study Total  
Number of Participants  
[units: participants]
  100  
Age  
[units: years]
Mean ± Standard Deviation
  63.5  ± 8.2  
Gender  
[units: Number¬†of¬†participants]
 
Female     46  
Male     54  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Secondary:   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. ]

4.  Secondary:   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 ]

5.  Secondary:   Peak FEV1 (0-3h) Response   [ Time Frame: Baseline and 6 weeks ]

6.  Secondary:   Trough FEV1 Response   [ Time Frame: Baseline and 6 weeks ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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. ]

10.  Secondary:   Peak FVC (0-3h) Response   [ Time Frame: Baseline and 6 weeks ]

11.  Secondary:   Trough FVC Response   [ Time Frame: Baseline and 6 weeks ]

12.  Secondary:   Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  1. Safety assessments are potentially confounded by both crossover and long washout periods
  2. Comparisons of active groups for the 12 to 24 hr period overestimate the effect of Foradil (sleeping period causing an overestimation of AUC)


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00932646     History of Changes
Other Study ID Numbers: 1222.25
Study First Received: July 2, 2009
Results First Received: March 28, 2014
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration