Tiotropium Bromide in Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01179347
First received: August 10, 2010
Last updated: November 27, 2013
Last verified: October 2013
Results First Received: February 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Cystic Fibrosis
Interventions: Drug: tiotropium Respimat® inhaler
Drug: Placebo Respimat® inhaler

  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
First part: double-blind, duration was 12 weeks, 464 patients were randomised to either Tio R5 or placebo in a 2:1 ratio, but 1 randomised patient was not treated. Second part: open-label, all patients received the active treatment for a minimum of 12 weeks to enlarge the safety database.

Reporting Groups
  Description
Placebo Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
Tio R5 qd Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.

Participant Flow for 2 periods

Period 1:   Double-blind Period (12 Weeks)
    Placebo     Tio R5 qd  
STARTED     155 [1]   308 [1]
COMPLETED     147 [2]   294 [2]
NOT COMPLETED     8     14  
Adverse Event                 2                 6  
Protocol Violation                 2                 0  
Lost to Follow-up                 1                 2  
Withdrawal by Subject                 1                 2  
Unknown                 2                 4  
[1] Entered and treated in double-blind period.
[2] Completed double-blind period.

Period 2:   Open-label Period (12 Weeks)
    Placebo     Tio R5 qd  
STARTED     147 [1]   294 [1]
COMPLETED     132 [2]   278 [2]
NOT COMPLETED     15     16  
Adverse Event                 5                 9  
Lack of Efficacy                 0                 2  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 1                 1  
Protocol Violation                 1                 0  
Unknown                 7                 4  
[1] Treated in open-label period.
[2] Completed open-label period.



  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 Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
Tio R5 qd Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
Total Total of all reporting groups

Baseline Measures
    Placebo     Tio R5 qd     Total  
Number of Participants  
[units: participants]
  155     308     463  
Age  
[units: years]
Mean ± Standard Deviation
  20.6  ± 13.6     19.3  ± 12.0     19.8  ± 12.5  
Gender  
[units: participants]
     
Female     65     139     204  
Male     90     169     259  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response   [ Time Frame: 30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks. ]

2.  Primary:   Trough FEV1 Response   [ Time Frame: Baseline and 12 weeks ]

3.  Secondary:   Forced Vital Capacity (FVC) Area Under the Curve 0-4 Hours (AUC0-4h) Response   [ Time Frame: 30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks. ]

4.  Secondary:   Trough FVC Response   [ Time Frame: Baseline and 12 weeks ]

5.  Secondary:   Pre-bronchodilator Forced Expiratory Flow Between 25 Percent and 75 Percent of the FVC (FEF25−75) Response   [ Time Frame: Baseline and 12 weeks ]

6.  Secondary:   Percentage of Participants With at Least 1 Pulmonary Exacerbation During Double-blind Treatment   [ Time Frame: 12 weeks ]

7.  Secondary:   Change From Baseline in Revised Cystic Fibrosis Questionnaire (CFQ-R) Score   [ Time Frame: Baseline and 12 weeks ]


  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
No text entered.


  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
ClinicalTrials.gov Identifier: NCT01179347     History of Changes
Other Study ID Numbers: 205.438, 2010-019802-17
Study First Received: August 10, 2010
Results First Received: February 13, 2013
Last Updated: November 27, 2013
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Austria: Federal Office for Safety in Health Care
Belgium:
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration