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Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00621582
First received: February 13, 2008
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
Results First Received: February 9, 2010  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Pulmonary Disease, Chronic Obstructive

  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

There is a gap between the enrollment number (4922) and the started patients (treatment number, 4812), as some of the enrolled patients did not accept the treatment.

the number of started patients was 4918, among which 106 patients prematurely discontinued

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
Tiotropium Bromide No text entered.

Participant Flow:   Overall Study
    Tiotropium Bromide  
STARTED     4918  
COMPLETED     4812  
NOT COMPLETED     106  
Adverse Event                 7  
Protocol Violation                 57  
Lost to Follow-up                 24  
issues not identified by investigators                 18  



  Baseline Characteristics
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Reporting Groups
  Description
Tiotropium Bromide No text entered.

Baseline Measures
    Tiotropium Bromide  
Number of Participants  
[units: participants]
 		  4918  
Age  
[units: years]
Mean ± Standard Deviation 		  63.8  ± 9.3  
Gender, Customized  
[units: participants]
 		 
Female     1603  
Male     3313  
Missing information     2  



  Outcome Measures

1.  Primary:   Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)   [ Time Frame: 0 weeks (Visit 1) and 8 weeks (Visit 3) ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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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: NCT00621582     History of Changes
Other Study ID Numbers: 205.373
Study First Received: February 13, 2008
Results First Received: February 9, 2010
Last Updated: May 18, 2012
Health Authority: China: