Trial record 1 of 3 for:    spiriva | cystic fibrosis
Previous Study | Return to List | Next Study

Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00737100
First received: August 15, 2008
Last updated: May 7, 2014
Last verified: January 2014
Results First Received: March 21, 2011  
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: Placebo Respimat
Drug: Tiotropium bromide 5 mcg
Drug: tiotropium bromide-low dose-2.5mcg

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Placebo Patients randomised to receive matching placebo
Tiotropium Respimat 2.5 Micrograms Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
Tiotropium Respimat 5 Micrograms Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily

Participant Flow:   Overall Study
    Placebo     Tiotropium Respimat 2.5 Micrograms     Tiotropium Respimat 5 Micrograms  
STARTED     168     166     176  
COMPLETED     161     159     169  
NOT COMPLETED     7     7     7  
Adverse Event                 6                 5                 3  
Lost to Follow-up                 0                 1                 0  
Withdrawal by Subject                 0                 0                 3  
Reason discontinued not explained above                 1                 1                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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 Patients randomised to receive matching placebo
Tiotropium Respimat 2.5 Micrograms Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
Tiotropium Respimat 5 Micrograms Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Tiotropium Respimat 2.5 Micrograms     Tiotropium Respimat 5 Micrograms     Total  
Number of Participants  
[units: participants]
  168     166     176     510  
Age  
[units: years]
Mean ± Standard Deviation
  20.4  ± 11.6     21.5  ± 12.0     20.7  ± 11.3     20.9  ± 11.6  
Age, Customized  
[units: years]
       
<= 11 years     44     42     52     138  
>= 12 years     124     124     124     372  
Gender  
[units: participants]
       
Female     72     81     82     235  
Male     96     85     94     275  
Race/Ethnicity, Customized  
[units: participants]
       
Asian     0     1     2     3  
Black/African American     0     3     2     5  
White     127     124     132     383  
Missing     39     35     37     111  
American Indian / Alaskan native     2     3     3     8  
Height  
[units: centimeters]
Mean ± Standard Deviation
  157.4  ± 17.2     157.7  ± 17.0     155.7  ± 18.2     156.9  ± 17.5  
Weight  
[units: kilograms]
Mean ± Standard Deviation
  52.1  ± 19.0     51.0  ± 17.3     50.4  ± 18.2     51.2  ± 18.1  
Body Mass Index  
[units: kilogram/square meter]
Mean ± Standard Deviation
  20.3  ± 4.4     19.9  ± 4.0     20.0  ± 4.1     20.1  ± 4.2  
Alcohol history  
[units: Participants]
       
Drinks no alcohol     130     112     132     374  
Drinks alcohol but should not interfere with trial     38     54     43     135  
Drinks alcohol but could interfere with trial     0     0     1     1  
Smoking history  
[units: Participants]
       
Never smoked     159     157     167     483  
Ex-smoker     7     5     7     19  
Currently smokes     2     4     2     8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Predicted FEV1 AUC0-4 Response at the End of Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Primary:   Percent Predicted FEV1 Trough Response at the End of Week 12   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Percent Predicted FVC AUC0-4 Response at the End of Week 12   [ Time Frame: Baseline, Week 12 ]

4.  Secondary:   Percent Predicted FVC Trough Response at the End of Week 12   [ Time Frame: Baseline, Week 12 ]

5.  Secondary:   Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12   [ Time Frame: Baseline, Week 12 ]

6.  Secondary:   Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:   Respiratory and Systemic Symptoms Questionnaire (RSSQ)   [ Time Frame: 12 weeks ]

8.  Secondary:   Change From Baseline in CFQ Scores - Adult Group   [ Time Frame: 12 weeks ]

9.  Secondary:   Change From Baseline in CFQ Scores - Adolescents Group   [ Time Frame: 12 weeks ]

10.  Secondary:   Change From Baseline in CFQ Scores - Parent Questionnaire   [ Time Frame: 12 weeks ]

11.  Secondary:   Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)   [ Time Frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose ]

12.  Secondary:   Maximum Measured Concentration at Steady State (Cmax,ss)   [ Time Frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose ]

13.  Secondary:   Time From Dosing to the Maximum Concentration (Tmax,ss)   [ Time Frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose ]

14.  Secondary:   Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation   [ Time Frame: From first drug administration until 30 days after last drug administration (up to 121 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00737100     History of Changes
Other Study ID Numbers: 205.339, 2008-001156-43
Study First Received: August 15, 2008
Results First Received: March 21, 2011
Last Updated: May 7, 2014
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: French Health Products Safety Agency 143-147 boulevard Anatole France 93285 Saint-Denis Cedex FRANCE
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Italy: Ethics Committee
Netherlands: Central Committee on Research involving human subjects (CCMO)
New Zealand: Multicentre Ethics Committee/Medsafe
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
United States: Food and Drug Administration