Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00615992
First received: January 24, 2008
Last updated: April 24, 2014
Last verified: April 2014
Results First Received: June 30, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort
Condition: Pulmonary Disease, Chronic Obstructive
Intervention: Drug: Tiotropium

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Spiriva® (Tiotropium Bromide) Tiotropium bromide 18μg inhalation capsules once-daily

Participant Flow:   Overall Study
    Spiriva® (Tiotropium Bromide)  
STARTED     754  
COMPLETED     687  
NOT COMPLETED     67  
Protocol Violation                 67  



  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.
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Reporting Groups
  Description
Spiriva® (Tiotropium Bromide) Tiotropium bromide 18μg inhalation capsules once-daily

Baseline Measures
    Spiriva® (Tiotropium Bromide)  
Number of Participants  
[units: participants]
  687  
Age  
[units: years]
Mean ± Standard Deviation
  63.0  ± 12.5  
Gender, Customized [1]
[units: participants]
 
Female     269  
Male     414  
Missing     4  
[1]

687 eligible for efficacy analysis (complete data set available)

Throughout this report, the discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.

Number of Participant in this summary is "number of patients used for analysis".




  Outcome Measures
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1.  Primary:   Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva   [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]

2.  Secondary:   Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva   [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]

3.  Secondary:   Global Assessment of Efficacy by Patient   [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]

4.  Secondary:   Global Assessment of Tolerability by Patient   [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]

5.  Secondary:   Global Assessment of Efficacy by Physician   [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]

6.  Secondary:   Global Assessment of Tolerability by Physician   [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]


  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: NCT00615992     History of Changes
Other Study ID Numbers: 205.398
Study First Received: January 24, 2008
Results First Received: June 30, 2009
Last Updated: April 24, 2014
Health Authority: Austria: Federal Office for Safety in Health Care