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Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01663987
First received: August 9, 2012
Last updated: June 17, 2015
Last verified: June 2015
Results First Received: May 1, 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 bromide
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomized, placebo-controlled, double blind, parallel group design involving an event-driven treatment period up to the close of the study and a minimum 30-day follow-up period up to the close of the study

Reporting Groups
  Description
Placebo Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
Tiotropium Bromide (18μg) Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.

Participant Flow:   Overall Study
    Placebo     Tiotropium Bromide (18μg)  
STARTED     39     40  
COMPLETED     26     34  
NOT COMPLETED     13     6  
Adverse Event                 7                 2  
Lost to Follow-up                 1                 1  
Withdrawal by Subject                 2                 3  
Other reason not defined above                 3                 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): The treated set included all patients randomized and who took at least one dose of the study drug.

Reporting Groups
  Description
Placebo Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
Tiotropium Bromide (18μg) Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
Total Total of all reporting groups

Baseline Measures
    Placebo     Tiotropium Bromide (18μg)     Total  
Number of Participants  
[units: participants]
  39     40     79  
Age  
[units: years]
Mean (Standard Deviation)
  58.4  (7.5)     58.9  (11.5)     58.7  (9.7)  
Gender  
[units: participants]
     
Female     22     24     46  
Male     17     16     33  



  Outcome Measures
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1.  Primary:   Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug   [ Time Frame: Baseline and 12 weeks ]

2.  Primary:   Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)   [ Time Frame: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years ]

3.  Secondary:   Change From Baseline of Trough FVC at 12 Weeks on Study Drug   [ Time Frame: Baseline and 12 weeks ]

4.  Secondary:   Percentage of Patients With Adverse Clinical Event on Study   [ Time Frame: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years ]

5.  Secondary:   Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)   [ Time Frame: Baseline and 12 weeks ]

6.  Secondary:   Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)   [ Time Frame: Baseline and 12 weeks ]

7.  Secondary:   Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)   [ Time Frame: from first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years ]

8.  Secondary:   Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)   [ Time Frame: from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years ]

9.  Secondary:   Percentage of Patients With 30-day Readmission Rates Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)   [ Time Frame: from date of hospital discharge prior to randomization up to readmission days >1 and <31 days ]

10.  Secondary:   Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)   [ Time Frame: Start of treatment to the last timepoint with information of clinical adverse outcome available, up to 2 years ]

11.  Secondary:   Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)   [ Time Frame: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years ]

12.  Secondary:   Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)   [ Time Frame: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
The original protocol planned to randomize 604 subjects, however this was not reached due to low patient enrollment. All results are descriptive only.


  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



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01663987     History of Changes
Other Study ID Numbers: 205.477
Study First Received: August 9, 2012
Results First Received: May 1, 2015
Last Updated: June 17, 2015
Health Authority: United States: Food and Drug Administration