Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00793624
First received: November 18, 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: Formoterol
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
Two subjects were randomized but not treated due to withdrawn consent and inability to perform spirometry prior to dosing.

Reporting Groups
  Description
Placebo Matching Placebo delivered by the Respimat Inhaler.
Olodaterol (Olo) 5 mcg qd Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
Olodaterol (Olo) 10 mcg qd Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
Form 12 mcg Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.

Participant Flow:   Overall Study
    Placebo     Olodaterol (Olo) 5 mcg qd     Olodaterol (Olo) 10 mcg qd     Form 12 mcg  
STARTED     225     227     225     227  
COMPLETED     168     191     186     184  
NOT COMPLETED     57     36     39     43  
Adverse Event                 18                 16                 15                 20  
Lost to Follow-up                 2                 2                 4                 0  
Withdrawal by Subject                 20                 9                 11                 14  
Lack of Efficacy                 9                 2                 1                 3  
Non compliance with protocol                 2                 3                 2                 3  
Other reason not described above                 6                 4                 6                 3  



  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.
Form 12 mcg Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
Total Total of all reporting groups

Baseline Measures
    Placebo     Olo 5 mcg qd     Olo 10 mcg qd     Form 12 mcg     Total  
Number of Participants  
[units: participants]
  225     227     225     227     904  
Age  
[units: years]
Mean ± Standard Deviation
  64.0  ± 8.4     63.7  ± 9.1     62.6  ± 8.8     64.8  ± 8.6     63.8  ± 8.7  
Gender  
[units: Number of participants]
         
Female     45     50     55     48     198  
Male     180     177     170     179     706  
Tiotropium (Tio) Use Stratum  
[units: Number of participants]
         
Non-tiotropium     169     168     167     169     673  
Tiotropium     56     59     58     58     231  



  Outcome Measures
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1.  Primary:   Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 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 on Week 24 ]

2.  Primary:   Trough FEV1 Response at Week 24   [ 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 at week 24. ]

3.  Primary:   Mahler Transitional Dyspnea Index Focal Score at 24 Weeks   [ Time Frame: Baseline, Week 24 ]

4.  Primary:   Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis   [ Time Frame: Baseline, Week 24 ]

5.  Secondary:   Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks   [ Time Frame: Baseline, Week 24 ]

6.  Secondary:   Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:   Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks   [ Time Frame: Baseline, Week 48 ]

8.  Secondary:   Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis   [ Time Frame: Baseline, Week 24 ]

9.  Secondary:   Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 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 on Week 2 ]

10.  Secondary:   Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 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 on Week 6 ]

11.  Secondary:   Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 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 Week 12 ]

12.  Secondary:   Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 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 on Week 48 ]

13.  Secondary:   Trough FEV1 Response at Week 2   [ 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 at week 2. ]

14.  Secondary:   Trough FEV1 Response at Week 6   [ 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 at week 6. ]

15.  Secondary:   Trough FEV1 Response at Week 12   [ 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 at week 12. ]

16.  Secondary:   Trough FEV1 Response at Week 18   [ 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 at week 18. ]

17.  Secondary:   Trough FEV1 Response at Week 32   [ 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 at week 32. ]

18.  Secondary:   Trough FEV1 Response at Week 40   [ 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 at week 40. ]

19.  Secondary:   Trough FEV1 Response at Week 48   [ 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 at week 48. ]

20.  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 ]

21.  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 ]

22.  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 ]

23.  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 ]

24.  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 ]

25.  Secondary:   Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 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 on Week 2 ]

26.  Secondary:   Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 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 on Week 6 ]

27.  Secondary:   Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 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 Week 12 ]

28.  Secondary:   Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 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 on Week 24 ]

29.  Secondary:   Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 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 on Week 48 ]

30.  Secondary:   Trough FVC Response at Week 2   [ 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 at week 2. ]

31.  Secondary:   Trough FVC Response at Week 6   [ 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 at week 6. ]

32.  Secondary:   Trough FVC Response at Week 12   [ 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 at week 12. ]

33.  Secondary:   Trough FVC Response at Week 18   [ 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 at week 18. ]

34.  Secondary:   Trough FVC Response at Week 24   [ 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 at week 24. ]

35.  Secondary:   Trough FVC Response at Week 32   [ 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 at week 32. ]

36.  Secondary:   Trough FVC Response at Week 48   [ 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 at week 48. ]

37.  Secondary:   Trough FVC Response at Week 40   [ 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 at week 40. ]

38.  Secondary:   Peak FVC (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 ]

39.  Secondary:   Peak FVC (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 ]

40.  Secondary:   Peak FVC (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 ]

41.  Secondary:   Peak FVC (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 ]

42.  Secondary:   Peak FVC (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 ]

43.  Secondary:   Peak Expiratory Flow Rate (PEFR) at Week 24   [ Time Frame: Week 24 ]

44.  Secondary:   Use of Rescue Medication at Week 24   [ Time Frame: Week 24 ]

45.  Secondary:   Patient's Global Rating (PGR) at 6 Weeks   [ Time Frame: Week 6 ]

46.  Secondary:   Patient's Global Rating (PGR) at 12 Weeks   [ Time Frame: Week 12 ]

47.  Secondary:   Patient's Global Rating (PGR) at 24 Weeks   [ Time Frame: Week 24 ]

48.  Secondary:   Patient's Global Rating (PGR) at 48 Weeks   [ Time Frame: Week 48 ]

49.  Secondary:   Mahler Transitional Dyspnea Index Focal Score at 6 Weeks   [ Time Frame: Baseline, Week 6 ]

50.  Secondary:   Mahler Transitional Dyspnea Index Focal Score at 12 Weeks   [ Time Frame: Baseline, Week 12 ]

51.  Secondary:   Mahler Transitional Dyspnea Index Focal Score at 18 Weeks   [ Time Frame: Baseline, Week 18 ]

52.  Secondary:   Mahler Transitional Dyspnea Index Focal Score at 32 Weeks   [ Time Frame: Baseline, Week 32 ]

53.  Secondary:   Mahler Transitional Dyspnea Index Focal Score at 40 Weeks   [ Time Frame: Baseline, Week 40 ]

54.  Secondary:   Mahler Transitional Dyspnea Index Focal Score at 48 Weeks   [ Time Frame: Baseline, Week 48 ]

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

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

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

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

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

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

61.  Secondary:   Absolute Plasma Concentrations   [ Time Frame: within 2 hours before first drug administration and 10 minutes post-dose at week 6, 12 and 18 ]

62.  Secondary:   Changes in Safety Parameters Related to Treatment   [ Time Frame: 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: NCT00793624     History of Changes
Other Study ID Numbers: 1222.13, 2008-001933-84
Study First Received: November 18, 2008
Results First Received: March 28, 2014
Last Updated: June 17, 2014
Health Authority: Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica)
Brazil: National Health Surveillance Agency
Canada: Therapeutic Products Directorate
Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Denmark: The Danish Medicines Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
India: Drugs Controller General of India
Italy: Comitato Etico per la sperim. clinica dei medicinali dell'A.O. Universitaria Pisana di Pisa
Korea, Republic of: Korea Food and Drug Administration
Malaysia: Ministry of Health
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Philippines: Department of Health
South Africa: Medicines Control Council
Spain: Agencia Espanola del Medicamento y Productos Sanitarios
Sweden: Medical Products Agency Regional Ethics Committee of Umeå
Thailand: Ministry of Public Health
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)