BI 1744 CL With Respimat Once Daily Versus Twice Daily in COPD

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00846768
First received: February 18, 2009
Last updated: May 29, 2014
Last verified: May 2014
Results First Received: March 28, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Intervention: Drug: BI 1744 CL

  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 multi-centre, randomised, double-blind, 4-way crossover trial. The duration of each treatment period was 3 weeks with no washout period between treatments.

Reporting Groups
  Description
Olo 2mcg Bid / Olo 10mcg qd / Olo 5mcg qd / Olo 5mcg Bid Patients were administered Olodaterol 2 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and Olodaterol 5 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler.
Olo 5mcg qd / Olo 2mcg Bid / Olo 5mcg Bid / Olo 10mcg qd Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg bid in the second period, Olodaterol 5 mcg bid in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler.
Olo 5mcg Bid / Olo 5mcg qd / Olo 10mcg qd / Olo 2mcg Bid Patients were administered Olodaterol 5 mcg bid in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 2 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler.
Olo 10mcg qd / Olo 5mcg Bid / Olo 2mcg Bid / Olo 5mcg qd Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg bid in the second period, Olodaterol 2 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler.

Participant Flow:   Overall Study
    Olo 2mcg Bid / Olo 10mcg qd / Olo 5mcg qd / Olo 5mcg Bid     Olo 5mcg qd / Olo 2mcg Bid / Olo 5mcg Bid / Olo 10mcg qd     Olo 5mcg Bid / Olo 5mcg qd / Olo 10mcg qd / Olo 2mcg Bid     Olo 10mcg qd / Olo 5mcg Bid / Olo 2mcg Bid / Olo 5mcg qd  
STARTED     11     12     12     12  
COMPLETED     11     11     12     12  
NOT COMPLETED     0     1     0     0  
Adverse Event                 0                 1                 0                 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, includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

Reporting Groups
  Description
Study Total Total number of patients treated in the study. This was a randomised, double-blind, active-controlled, 4 way crossover trial. 47 patients were assigned randomly to one of 4 treatment sequences in which they received each of the 4 treatments. The duration of each treatment period was 3 weeks with no washout period between treatments.

Baseline Measures
    Study Total  
Number of Participants  
[units: participants]
  47  
Age  
[units: years]
Mean ± Standard Deviation
  65.57  ± 7.96  
Gender  
[units: Number¬†of¬†participants]
 
Female     11  
Male     36  



  Outcome Measures
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1.  Primary:   FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment   [ Time Frame: Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose ]

2.  Primary:   FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment   [ Time Frame: Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose ]

3.  Secondary:   FEV1 Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment   [ Time Frame: Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1,0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose ]

4.  Secondary:   Peak FEV1 (0-3h) Response After 3 Weeks   [ Time Frame: Baseline, 3 weeks ]

5.  Secondary:   Trough FEV1 Response   [ Time Frame: Baseline, 3 weeks ]

6.  Secondary:   FVC Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment   [ Time Frame: Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose ]

7.  Secondary:   FVC Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment   [ Time Frame: Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose ]

8.  Secondary:   FVC Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment   [ Time Frame: Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1, 0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose ]

9.  Secondary:   Peak FVC (0-3h) Response After 3 Weeks   [ Time Frame: Baseline, 3 weeks ]

10.  Secondary:   Trough FVC Response   [ Time Frame: Baseline, 3 weeks ]

11.  Secondary:   Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination   [ Time Frame: 3 weeks ]

12.  Secondary:   Pharmacokinetics (PK): Concentration of the Analyte in Plasma Measured at 0.167 Hours Post Dosing at Steady State   [ Time Frame: 3 weeks ]

13.  Secondary:   Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 12 Hours   [ Time Frame: 3 weeks ]

14.  Secondary:   Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 24 Hours   [ Time Frame: 3 weeks ]

15.  Secondary:   Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 12 Hours   [ Time Frame: 3 weeks ]

16.  Secondary:   Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 24 Hours   [ Time Frame: 3 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: NCT00846768     History of Changes
Other Study ID Numbers: 1222.26, EudtaCT No: 2008-006334-10
Study First Received: February 18, 2009
Results First Received: March 28, 2014
Last Updated: May 29, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Netherlands: Central Committee Research Involving Human Subjects