Evaluation of Tiotropium 5 µg/Day Delivered Via the Respimat® Inhaler Over 48 Weeks in Patients With Severe Persistent Asthma on Top of Usual Care (Study I)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00772538
First received: October 13, 2008
Last updated: May 7, 2014
Last verified: September 2013
Results First Received: July 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: tiotropium 5mcg/day
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
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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
Placebo Patients treated with matching placebo
Tio R5 Patients treated with tiotropium inhalation solution 5 microgram qd

Participant Flow:   Overall Study
    Placebo     Tio R5  
STARTED     222     237  
COMPLETED     202     211  
NOT COMPLETED     20     26  
Adverse Event                 6                 6  
Protocol Violation                 3                 3  
Lost to Follow-up                 1                 1  
Withdrawal by Subject                 3                 8  
Lack of Efficacy                 0                 1  
Unknown                 7                 7  



  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
Placebo Patients treated with matching placebo
Tio R5 Patients treated with tiotropium inhalation solution 5 microgram qd
Total Total of all reporting groups

Baseline Measures
    Placebo     Tio R5     Total  
Number of Participants  
[units: participants]
  222     237     459  
Age  
[units: Years]
Mean ± Standard Deviation
  53.9  ± 12.8     52.9  ± 12.4     53.4  ± 12.6  
Gender  
[units: Participants]
     
Female     143     146     289  
Male     79     91     170  



  Outcome Measures
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1.  Primary:   Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.   [ Time Frame: Baseline and 24 weeks ]

2.  Primary:   Trough FEV1 Response Determined After a Treatment Period of 24 Weeks.   [ Time Frame: Baseline and 24 weeks ]

3.  Primary:   Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984).   [ Time Frame: 48 weeks ]

4.  Secondary:   Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.   [ Time Frame: Baseline and 24 weeks ]

5.  Secondary:   Trough FVC Response at the End of the 24-week Treatment Period.   [ Time Frame: Baseline and 24 weeks ]

6.  Secondary:   FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.   [ Time Frame: Baseline and 24 weeks ]

7.  Secondary:   FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.   [ Time Frame: Baseline and 24 weeks ]

8.  Secondary:   Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.   [ Time Frame: Baseline and 48 weeks ]

9.  Secondary:   Trough FEV1 Response at the End of the 48-week Treatment Period.   [ Time Frame: Baseline and 48 weeks ]

10.  Secondary:   AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.   [ Time Frame: Baseline and 48 weeks ]

11.  Secondary:   Peak FVC 0-3h Response at the End of the 48-week Treatment Period.   [ Time Frame: Baseline and 48 weeks ]

12.  Secondary:   Trough FVC Response at the End of the 48-week Treatment Period.   [ Time Frame: Baseline and 48 weeks ]

13.  Secondary:   FVC AUC0-3h Response at the End of the 48-week Treatment Period.   [ Time Frame: Baseline and 48 weeks ]

14.  Secondary:   Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit .   [ Time Frame: Baseline and last 7 days before week 24 visit ]

15.  Secondary:   Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit.   [ Time Frame: Baseline and last 7 days before week 24 visit ]

16.  Secondary:   Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.   [ Time Frame: Baseline and last 7 days before week 24 visit ]

17.  Secondary:   Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit.   [ Time Frame: Baseline and last 7 days before week 24 visit ]

18.  Secondary:   Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit.   [ Time Frame: Baseline and last 7 days before week 24 visit ]

19.  Secondary:   Time to First Severe Asthma Exacerbation During the 48-week Treatment.   [ Time Frame: 48 weeks ]

20.  Secondary:   Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.   [ Time Frame: 48 weeks ]

21.  Secondary:   Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.   [ Time Frame: 48 weeks ]

22.  Secondary:   Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.   [ Time Frame: 48 weeks ]

23.  Secondary:   Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.   [ Time Frame: 48 weeks ]

24.  Secondary:   Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.   [ Time Frame: 48 weeks ]

25.  Secondary:   Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.   [ Time Frame: 48 weeks ]

26.  Secondary:   Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.   [ Time Frame: 48 weeks ]

27.  Secondary:   Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.   [ Time Frame: 24 weeks ]

28.  Secondary:   AQLQ(S) Total Score at the End of the 48-week Treatment Period.   [ Time Frame: 48 weeks ]

29.  Secondary:   Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.   [ Time Frame: 24 weeks ]

30.  Secondary:   ACQ at the End of the 48-week Treatment Period.   [ Time Frame: 48 weeks ]

31.  Secondary:   Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit .   [ Time Frame: Baseline and last 7 days before week 24 visit ]

32.  Secondary:   Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit .   [ Time Frame: Baseline and last 7 days before week 24 visit ]


  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 by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00772538     History of Changes
Other Study ID Numbers: 205.416, 2008-001413-14
Study First Received: October 13, 2008
Results First Received: July 25, 2012
Last Updated: May 7, 2014
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Canada: Health Canada
Denmark: The Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Italy: Ethics Committee
Japan: Ministry of Health, Labor and Welfare
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health Care and Social Progress of Russian Federation
Serbia: Medicines and Medical Devices Agency of Serbia, 11152 Belgrade
South Africa: Medicines Control Council
Turkey: Ministry of Health Central Ethics Committee
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration