Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01696058
First received: September 26, 2012
Last updated: November 13, 2014
Last verified: November 2014
Results First Received: September 5, 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: Tiotropium
Drug: Placebo matching Olodaterol
Drug: Olodaterol

  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
1137 patients were entered and randomized to treatment and 1135 patients were treated with study medication.

Reporting Groups
  Description
Olodaterol (5μg) and Tiotropium (18μg)

2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered

Olodaterol: One dose

Tiotropium: Marketed dose

Placebo and Tiotropium (18μg)

2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered

Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning

Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning


Participant Flow:   Overall Study
    Olodaterol (5μg) and Tiotropium (18μg)     Placebo and Tiotropium (18μg)  
STARTED     566     569  
COMPLETED     523     538  
NOT COMPLETED     43     31  
Adverse Event                 21                 11  
Lack of Efficacy                 2                 3  
Protocol Violation                 9                 3  
Lost to Follow-up                 2                 5  
Withdrawal by Subject                 4                 6  
Other reason prematurely discontinued                 5                 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.
Treated set (TS), which includes all randomized patients who receive at least one dose of double-blind study treatment.

Reporting Groups
  Description
Olodaterol (5μg) and Tiotropium (18μg)

2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered

Olodaterol: One dose

Tiotropium: Marketed dose

Placebo and Tiotropium (18μg)

2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered

Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning

Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning

Total Total of all reporting groups

Baseline Measures
    Olodaterol (5μg) and Tiotropium (18μg)     Placebo and Tiotropium (18μg)     Total  
Number of Participants  
[units: participants]
  566     569     1135  
Age  
[units: years]
Mean (Standard Deviation)
  64.6  (9.0)     63.6  (8.9)     64.1  (9.0)  
Gender  
[units: participants]
     
Female     261     266     527  
Male     305     303     608  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12   [ Time Frame: baseline and 12 weeks ]

2.  Primary:   Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12   [ Time Frame: baseline and 12 weeks ]

3.  Secondary:   Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data   [ Time Frame: 12 weeks ]

4.  Secondary:   Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline   [ Time Frame: baseline and 12 weeks ]

5.  Secondary:   FVC AUC0-3h Response at 12 Weeks; Defined as Change From Baseline   [ Time Frame: baseline and 12 Weeks ]

6.  Secondary:   Peak FVC Response at 12 Weeks; Defined as Change From Baseline   [ Time Frame: baseline and 12 weeks ]

7.  Secondary:   Trough FVC Response at 12 Weeks; Defined as Change From Baseline   [ Time Frame: baseline and 12 weeks ]

8.  Secondary:   Rescue Medication Usage - Percentage of Rescue Free Days   [ Time Frame: over 12 weeks ]

9.  Secondary:   Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)   [ Time Frame: over 12 weeks ]

10.  Secondary:   Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)   [ Time Frame: over 12 weeks ]

11.  Secondary:   Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)   [ Time Frame: over 12 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 by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01696058     History of Changes
Other Study ID Numbers: 1222.52
Study First Received: September 26, 2012
Results First Received: September 5, 2014
Last Updated: November 13, 2014
Health Authority: United States: Food and Drug Administration