Tiotropium (18mcg) in Chronic Obstructive Pulmonary Disease (COPD) Patients With a Respiratory Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01483625
First received: November 30, 2011
Last updated: March 5, 2014
Last verified: March 2014
Results First Received: December 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: tiotropium
Drug: Placebo

  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
In this 12-week, randomised, double-blind, placebo-controlled, parallel group, multi-center Phase IV trial in chronic obstructive pulmonary disease (COPD), 140 patients were randomised to either Tiotropium 18 mcg or Placebo. Sixty eight (68) patients received Tiotropium 18 mcg and seventy two (72) patients received Placebo.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo placebo - Placebo Inhalation capsule, HandiHaler®
Tiotropium 18 mcg active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®

Participant Flow:   Overall Study
    Placebo     Tiotropium 18 mcg  
STARTED     72     68  
COMPLETED     68     66  
NOT COMPLETED     4     2  
Adverse Event                 1                 1  
Refused to continue medication                 2                 1  
Due to other reason                 1                 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.
No text entered.

Reporting Groups
  Description
Placebo placebo - Placebo Inhalation capsule, HandiHaler®
Tiotropium 18mcg active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
Total Total of all reporting groups

Baseline Measures
    Placebo     Tiotropium 18mcg     Total  
Number of Participants  
[units: participants]
  72     68     140  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     59     53     112  
>=65 years     13     15     28  
Age  
[units: years]
Mean ± Standard Deviation
  56.8  ± 8.7     59.2  ± 8.5     58.0  ± 8.7  
Gender  
[units: participants]
     
Female     34     43     77  
Male     38     25     63  
Trough forced expiratory value (FEV1)  
[units: Litre]
Mean ± Standard Deviation
  1.75  ± 0.65     1.56  ± 0.61     1.65  ± 0.64  



  Outcome Measures
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1.  Primary:   Trough FEV1 After 12 Weeks on Study Drug   [ Time Frame: 12 weeks ]

2.  Secondary:   Time to Recovery From Acute Respiratory Symptoms   [ Time Frame: 12 weeks ]

3.  Secondary:   Trough FVC (in Litres) at 12 Weeks   [ Time Frame: 12 weeks ]

4.  Secondary:   Responder Status at Week 4 Clinic Visit   [ Time Frame: 4 weeks ]

5.  Secondary:   Responder Status at Week 12 Clinic Visit   [ Time Frame: 12 weeks ]

6.  Secondary:   Weekly Rescue Medication Use Over the 12 Weeks of Study   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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
ClinicalTrials.gov Identifier: NCT01483625     History of Changes
Other Study ID Numbers: 205.479
Study First Received: November 30, 2011
Results First Received: December 23, 2013
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration