Japan Long-term Safety for Tiotropium Plus Olodaterol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01536262
First received: February 16, 2012
Last updated: June 19, 2015
Last verified: June 2015
Results First Received: June 19, 2015  
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 + Olodaterol
Device: Respimat
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
This study was a 52-week multi-centre, randomised, double-blind and parallel-group design.

Reporting Groups
  Description
Olodaterol (5 μg) Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
Tiotropium + Olodaterol (2.5 / 5 μg) Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
Tiotropium + Olodaterol (5 / 5 μg) Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.

Participant Flow:   Overall Study
    Olodaterol (5 μg)     Tiotropium + Olodaterol (2.5 / 5 μg)     Tiotropium + Olodaterol (5 / 5 μg)  
STARTED     41     40     41  
COMPLETED     33     38     39  
NOT COMPLETED     8     2     2  
Adverse Event                 6                 1                 2  
Withdrawal by Subject                 1                 1                 0  
Other than stated above                 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 (TS): This patient set included all patients who received at least 1 dose of treatment.

Reporting Groups
  Description
Olodaterol (5 μg) Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
Tiotropium + Olodaterol (2.5 / 5 μg) Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
Tiotropium + Olodaterol (5 / 5 μg) Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
Total Total of all reporting groups

Baseline Measures
    Olodaterol (5 μg)     Tiotropium + Olodaterol (2.5 / 5 μg)     Tiotropium + Olodaterol (5 / 5 μg)     Total  
Number of Participants  
[units: participants]
  41     40     41     122  
Age  
[units: years]
Mean (Standard Deviation)
  71.5  (7.2)     70.0  (7.5)     68.1  (7.1)     69.9  (7.3)  
Gender  
[units: participants]
       
Female     1     1     3     5  
Male     40     39     38     117  



  Outcome Measures
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1.  Primary:   Number (%) of Patients With Drug-related AEs   [ Time Frame: From first drug administration until 21 days after the last administration, upto 392 days ]

2.  Secondary:   FEV1 AUC0-3h Response   [ Time Frame: Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks ]

3.  Secondary:   Trough FEV1 Response   [ Time Frame: Baseline and 1 h, 10 min pre-dose after 52 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
No text entered.


  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
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01536262     History of Changes
Other Study ID Numbers: 1237.22
Study First Received: February 16, 2012
Results First Received: June 19, 2015
Last Updated: June 19, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare