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Trial record 1 of 1 for:    NCT00782509
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12 / 48 wk Pivotal PFT vs PBO in COPD II

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00782509
First received: October 29, 2008
Last updated: June 17, 2014
Last verified: June 2014
Results First Received: March 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: Olodaterol (BI 1744)
Drug: Placebo

  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
644 patients were randomised into the study, however two of the patients were not treated.

Reporting Groups
  Description
Placebo Matching Placebo delivered by the Respimat Inhaler.
Olo 5 mcg qd Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
Olo 10 mcg qd Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.

Participant Flow:   Overall Study
    Placebo     Olo 5 mcg qd     Olo 10 mcg qd  
STARTED     216     209     217  
COMPLETED     175     185     181  
NOT COMPLETED     41     24     36  
Adverse Event                 20                 10                 20  
Lost to Follow-up                 1                 2                 3  
Withdrawal by Subject                 3                 5                 8  
Non compliance with protocol                 2                 0                 0  
Other reasons not stated above                 5                 2                 3  
Lack of Efficacy                 10                 5                 2  



  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.
No text entered.

Reporting Groups
  Description
Placebo Matching Placebo delivered by the Respimat Inhaler.
Olo 5 mcg qd Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
Olo 10 mcg qd Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
Total Total of all reporting groups

Baseline Measures
    Placebo     Olo 5 mcg qd     Olo 10 mcg qd     Total  
Number of Participants  
[units: participants]
  216     209     217     642  
Age  
[units: years]
Mean ± Standard Deviation
  63.8  ± 8.3     64.7  ± 8.1     65.4  ± 9.7     64.6  ± 8.8  
Gender  
[units: Number of participants]
       
Female     64     57     65     186  
Male     152     152     152     456  
Tiotropium (Tio) Use Stratum  
[units: Number of participants]
       
Non-tiotropium     175     170     173     518  
Tiotropium     41     39     44     124  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks)   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85 ]

2.  Primary:   Trough FEV1 Response at Day 85 (12 Weeks)   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85. ]

3.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks) ]

4.  Secondary:   Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response At Day 1   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1 ]

5.  Secondary:   Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks ]

6.  Secondary:   Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -1h, -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks ]

7.  Secondary:   Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks ]

8.  Secondary:   Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 48 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks ]

9.  Secondary:   Trough FEV1 Response After 2 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks ]

10.  Secondary:   Trough FEV1 Response After 6 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks ]

11.  Secondary:   Trough FEV1 Response After 18 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks ]

12.  Secondary:   Trough FEV1 Response After 24 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks ]

13.  Secondary:   Trough FEV1 Response After 32 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks ]

14.  Secondary:   Trough FEV1 Response After 40 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks ]

15.  Secondary:   Trough FEV1 Response After 48 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks ]

16.  Secondary:   Peak FEV1 (0-3h) Response At Day 1   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1 ]

17.  Secondary:   Peak FEV1 (0-3h) Response After 2 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks ]

18.  Secondary:   Peak FEV1 (0-3h) Response After 6 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks ]

19.  Secondary:   Peak FEV1 (0-3h) Response After 12 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks ]

20.  Secondary:   Peak FEV1 (0-3h) Response After 24 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks ]

21.  Secondary:   Peak FEV1 (0-3h) Response After 48 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks ]

22.  Secondary:   Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1 ]

23.  Secondary:   Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks ]

24.  Secondary:   FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks ]

25.  Secondary:   FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks ]

26.  Secondary:   FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks ]

27.  Secondary:   FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks ]

28.  Secondary:   Trough FVC Response After 2 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks ]

29.  Secondary:   Trough FVC Response After 6 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks ]

30.  Secondary:   Trough FVC Response After 12 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 12 weeks ]

31.  Secondary:   Trough FVC Response After 18 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks ]

32.  Secondary:   Trough FVC Response After 24 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks ]

33.  Secondary:   Trough FVC Response After 32 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks ]

34.  Secondary:   Trough FVC Response After 40 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks ]

35.  Secondary:   Trough FVC Response After 48 Weeks   [ Time Frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks ]

36.  Secondary:   FVC Peak (0-3h) Response At Day 1   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1 ]

37.  Secondary:   FVC Peak (0-3h) Response After 2 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks ]

38.  Secondary:   FVC Peak (0-3h) Response After 6 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks ]

39.  Secondary:   FVC Peak (0-3h) Response After 12 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks ]

40.  Secondary:   FVC Peak (0-3h) Response After 24 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks ]

41.  Secondary:   FVC Peak (0-3h) Response After 48 Weeks   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks ]

42.  Secondary:   Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)   [ Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks) ]

43.  Secondary:   Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF)   [ Time Frame: immediately upon arising (before drug administration) from Screening to week 48 ]

44.  Secondary:   Weekly Mean Evening Peak Expiratory Flow Rate (PEF)   [ Time Frame: at bedtime from Screening to week 48 ]

45.  Secondary:   Weekly Mean of Daily Daytime Rescue Use   [ Time Frame: Week 48 ]

46.  Secondary:   Weekly Mean of Daily Nighttime Rescue Use   [ Time Frame: Week 48 ]

47.  Secondary:   Weekly Mean of Daily (24h) Rescue Use   [ Time Frame: Week 48 ]

48.  Secondary:   Patient's Global Rating at Week 6   [ Time Frame: Week 6 visit ]

49.  Secondary:   Patient's Global Rating at Week 12   [ Time Frame: Week 12 visit ]

50.  Secondary:   Patient's Global Rating at Week 24   [ Time Frame: Week 24 visit ]

51.  Secondary:   Patient's Global Rating at Week 48   [ Time Frame: Week 48 visit ]

52.  Secondary:   Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation   [ Time Frame: Baseline to end of study at 48 weeks. ]

53.  Secondary:   Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization   [ Time Frame: Baseline to end of study at 48 weeks. ]

54.  Secondary:   Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation   [ Time Frame: Baseline to end of study at 48 weeks. ]

55.  Secondary:   Number of COPD Exacerbations   [ Time Frame: Baseline to end of study at week 48 visit ]

56.  Secondary:   Number of COPD Exacerbations Requiring Hospitalization   [ Time Frame: Baseline to end of study at week 48 visit ]

57.  Secondary:   Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations   [ Time Frame: Baseline to end of study at 48 weeks. ]

58.  Secondary:   Changes in Safety Parameters Related to Treatment   [ Time Frame: 48 weeks ]

59.  Secondary:   Change From Baseline in Potassium   [ Time Frame: Day 1 and at 12, 24 and 48 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
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  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: NCT00782509     History of Changes
Other Study ID Numbers: 1222.12, 2008-003704-67
Study First Received: October 29, 2008
Results First Received: March 28, 2014
Last Updated: June 17, 2014
Health Authority: China: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Taiwan: Department of Health, Executive Yuan, Taiwan
United States: Food and Drug Administration