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NCT00737100 Clinical Trial

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

Cystic Fibrosis Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00737100
Other study ID # 205.339
Secondary ID 2008-001156-43
Status Completed
Phase Phase 2
First received August 15, 2008
Last updated May 7, 2014
Start date September 2008

Study information
Verified date January 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Australia: Dept of Health and Ageing Therapeutic Goods AdminBelgium: Federal Agency for Medicines and Health Products, FAMHPFrance: French Health Products Safety Agency 143-147 boulevard Anatole France 93285 Saint-Denis Cedex FRANCEGermany: Federal Institute for Drugs and Medical DevicesGreat Britain: MHRAItaly: Ethics CommitteeNetherlands: Central Committee on Research involving human subjects (CCMO)New Zealand: Multicentre Ethics Committee/MedsafePortugal: National Pharmacy and Medicines InstituteRussia: Pharmacological Committee, Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations

Recruitment information / eligibility
Status Completed
Enrollment 510
Est. completion date
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion criteria:

1. Male or female patients

2. Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable mutations)

3. Pre-bronchodilator FEV1 greater/equal 25% of predicted values

Exclusion criteria:

1. Significant history of allergy/hypersensitivity

2. Hypersensitivity to study drug

3. Participation in another trial

4. Female patients who are pregnant or lactating

5. Female patients of childbearing potential

6. Patients who have started a new medication for CF within 4 weeks of screening

7. Patients with known substance abuse

8. Clinically significant disease other than CF

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo Respimat
patient to receive placebo matching active drug once daily
• Tiotropium bromide 5 mcg
patient to recieve high dose tiotropium once daily
• tiotropium bromide-low dose-2.5mcg
patient to receive low dose tiotropium once daily

Locations
Country Name City State
Australia 205.339.103 Boehringer Ingelheim Investigational Site Adelaide South Australia
Australia 205.339.104 Boehringer Ingelheim Investigational Site Subiaco Western Australia
Australia 205.339.100 Boehringer Ingelheim Investigational Site Westmead New South Wales
Australia 205.339.101 Boehringer Ingelheim Investigational Site Westmead New South Wales
Belgium 205.339.111 Boehringer Ingelheim Investigational Site Bruxelles
Belgium 205.339.112 Boehringer Ingelheim Investigational Site Jette
Belgium 205.339.110 Boehringer Ingelheim Investigational Site Leuven
France 205.339.3310A Boehringer Ingelheim Investigational Site Amiens
France 205.339.3317A Boehringer Ingelheim Investigational Site Angers
France 205.339.3317C Boehringer Ingelheim Investigational Site Angers
France 205.339.3317D Boehringer Ingelheim Investigational Site Angers
France 205.339.3317E Boehringer Ingelheim Investigational Site Angers
France 205.339.3314A Boehringer Ingelheim Investigational Site BRON Cedex
France 205.339.3314B Boehringer Ingelheim Investigational Site BRON Cedex
France 205.339.3314C Boehringer Ingelheim Investigational Site BRON Cedex
France 205.339.3302B Boehringer Ingelheim Investigational Site Lille
France 205.339.3302A Boehringer Ingelheim Investigational Site Lille Cedex
France 205.339.3302C Boehringer Ingelheim Investigational Site Lille Cedex
France 205.339.3303A Boehringer Ingelheim Investigational Site Lisieux
France 205.339.3304A Boehringer Ingelheim Investigational Site Montpellier
France 205.339.3304B Boehringer Ingelheim Investigational Site Montpellier
France 205.339.3308A Boehringer Ingelheim Investigational Site Nantes
France 205.339.3308B Boehringer Ingelheim Investigational Site Nantes
France 205.339.3308C Boehringer Ingelheim Investigational Site Nantes
France 205.339.3312A Boehringer Ingelheim Investigational Site Paris
France 205.339.3312C Boehringer Ingelheim Investigational Site Paris
France 205.339.3313A Boehringer Ingelheim Investigational Site Paris
France 205.339.3313B Boehringer Ingelheim Investigational Site Paris
France 205.339.3301B Boehringer Ingelheim Investigational Site Paris Cedex 14
France 205.339.3318A Boehringer Ingelheim Investigational Site Rennes
France 205.339.3318C Boehringer Ingelheim Investigational Site Rennes
France 205.339.3318G Boehringer Ingelheim Investigational Site Rennes
France 205.339.3315C Boehringer Ingelheim Investigational Site Roscoff Cedex
France 205.339.3315D Boehringer Ingelheim Investigational Site Roscoff Cedex
France 205.339.3306A Boehringer Ingelheim Investigational Site Rouen cedex
France 205.339.3306B Boehringer Ingelheim Investigational Site Rouen cedex
France 205.339.3307A Boehringer Ingelheim Investigational Site Rouen cedex
France 205.339.3309A Boehringer Ingelheim Investigational Site Vandoeuvre les Nancy
France 205.339.3316A Boehringer Ingelheim Investigational Site Vannes
Germany 205.339.49132 Boehringer Ingelheim Investigational Site Erlangen
Germany 205.339.49137 Boehringer Ingelheim Investigational Site Frankfurt
Germany 205.339.49133 Boehringer Ingelheim Investigational Site Frankfurt/Main
Germany 205.339.49134 Boehringer Ingelheim Investigational Site Freiburg
Germany 205.339.49131 Boehringer Ingelheim Investigational Site Gerlingen
Germany 205.339.49145 Boehringer Ingelheim Investigational Site Hamburg
Germany 205.339.49135 Boehringer Ingelheim Investigational Site Hannover
Germany 205.339.49141 Boehringer Ingelheim Investigational Site Heidelberg
Germany 205.339.49140 Boehringer Ingelheim Investigational Site München
Germany 205.339.49142 Boehringer Ingelheim Investigational Site München
Germany 205.339.49130 Boehringer Ingelheim Investigational Site Tübingen
Italy 205.339.233 Boehringer Ingelheim Investigational Site Ancona
Italy 205.339.231 Boehringer Ingelheim Investigational Site Firenze
Italy 205.339.234 Boehringer Ingelheim Investigational Site Genova
Netherlands 205.339.171 Boehringer Ingelheim Investigational Site Groesbeek
Netherlands 205.339.170 Boehringer Ingelheim Investigational Site Rotterdam
New Zealand 205.339.105 Boehringer Ingelheim Investigational Site Grafton / Auckland
New Zealand 205.339.106 Boehringer Ingelheim Investigational Site Hamilton
Portugal 205.339.221 Boehringer Ingelheim Investigational Site Lisboa
Portugal 205.339.225 Boehringer Ingelheim Investigational Site Lisboa
Portugal 205.339.223 Boehringer Ingelheim Investigational Site Porto
Portugal 205.339.224 Boehringer Ingelheim Investigational Site Porto
Russian Federation 205.339.07001 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 205.339.07002 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 205.339.07003 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 205.339.07007 Boehringer Ingelheim Investigational Site Rostov-on-Don
Russian Federation 205.339.07005 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 205.339.07006 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 205.339.07008 Boehringer Ingelheim Investigational Site Voronezh
Russian Federation 205.339.07004 Boehringer Ingelheim Investigational Site Yaroslavl
United Kingdom 205.339.44180 Boehringer Ingelheim Investigational Site Belfast
United Kingdom 205.339.44190 Boehringer Ingelheim Investigational Site Birmingham
United Kingdom 205.339.44193 Boehringer Ingelheim Investigational Site Boston
United Kingdom 205.339.44192 Boehringer Ingelheim Investigational Site Leeds
United Kingdom 205.339.44191 Boehringer Ingelheim Investigational Site Lincoln
United Kingdom 205.339.44185 Boehringer Ingelheim Investigational Site Liverpool
United Kingdom 205.339.44186 Boehringer Ingelheim Investigational Site Liverpool
United Kingdom 205.339.44183 Boehringer Ingelheim Investigational Site Nottingham
United Kingdom 205.339.44182 Boehringer Ingelheim Investigational Site Oxford
United Kingdom 205.339.44194 Boehringer Ingelheim Investigational Site Plymouth
United Kingdom 205.339.44181 Boehringer Ingelheim Investigational Site Sheffield
United Kingdom 205.339.44184 Boehringer Ingelheim Investigational Site Wolverhampton
United States 205.339.017 Boehringer Ingelheim Investigational Site Ann Arbor Michigan
United States 205.339.010 Boehringer Ingelheim Investigational Site Charleston South Carolina
United States 205.339.011 Boehringer Ingelheim Investigational Site Charlottesville Virginia
United States 205.339.024 Boehringer Ingelheim Investigational Site Cleveland Ohio
United States 205.339.026 Boehringer Ingelheim Investigational Site Colchester Vermont
United States 205.339.025 Boehringer Ingelheim Investigational Site Detroit Michigan
United States 205.339.004 Boehringer Ingelheim Investigational Site Fort Worth Texas
United States 205.339.016 Boehringer Ingelheim Investigational Site Grand Rapids Michigan
United States 205.339.014 Boehringer Ingelheim Investigational Site Indianapolis Indiana
United States 205.339.022 Boehringer Ingelheim Investigational Site Indianapolis Indiana
United States 205.339.001 Boehringer Ingelheim Investigational Site Iowa City Iowa
United States 205.339.023 Boehringer Ingelheim Investigational Site Jacksonville Florida
United States 205.339.018 Boehringer Ingelheim Investigational Site Lebanon New Hampshire
United States 205.339.029 Boehringer Ingelheim Investigational Site Long Branch New Jersey
United States 205.339.021 Boehringer Ingelheim Investigational Site Miami Florida
United States 205.339.003 Boehringer Ingelheim Investigational Site Milwaukee Wisconsin
United States 205.339.009 Boehringer Ingelheim Investigational Site Morristown New Jersey
United States 205.339.020 Boehringer Ingelheim Investigational Site Oklahoma City Oklahoma
United States 205.339.032 Boehringer Ingelheim Investigational Site Oklahoma City Oklahoma
United States 205.339.030 Boehringer Ingelheim Investigational Site Orlando Florida
United States 205.339.031 Boehringer Ingelheim Investigational Site Orlando Florida
United States 205.339.005 Boehringer Ingelheim Investigational Site Salt Lake City Utah
United States 205.339.019 Boehringer Ingelheim Investigational Site San Diego California
United States 205.339.013 Boehringer Ingelheim Investigational Site South Bend Indiana
United States 205.339.002 Boehringer Ingelheim Investigational Site Syracuse New York
United States 205.339.006 Boehringer Ingelheim Investigational Site Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Italy,  Netherlands,  New Zealand,  Portugal,  Russian Federation,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent Predicted FEV1 AUC0-4 Response at the End of Week 12 Outcome measure description: Change from baseline in percent predicted Forced Expiratory Volume in one second (FEV1) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline. Baseline, Week 12 No
Primary Percent Predicted FEV1 Trough Response at the End of Week 12 Outcome measure description: Change from baseline in percent predicted trough Forced Expiratory Volume in one second. Calculated as percent predicted at week 12 minus percent predicted at baseline. Baseline, Week 12 No
Secondary Percent Predicted FVC AUC0-4 Response at the End of Week 12 Change from baseline in percent predicted Forced Vital Capacity (FVC) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline. Baseline, Week 12 No
Secondary Percent Predicted FVC Trough Response at the End of Week 12 Change from baseline in percent predicted trough Forced Vital Capacity (FVC). Calculated as percent predicted at week 12 minus percent predicted at baseline. Baseline, Week 12 No
Secondary Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12 Forced Expiratory Flow at 25-75% of vital capacity (FEF25-75). Calculated as percent predicted at week 12 minus percent predicted at baseline. Baseline, Week 12 No
Secondary Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12 Change from baseline in static lung hyperinflation as measured by RV/TLC. Calculated as percent predicted at week 12 minus percent predicted at baseline. Baseline, Week 12 No
Secondary Respiratory and Systemic Symptoms Questionnaire (RSSQ) Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period. 12 weeks No
Secondary Change From Baseline in CFQ Scores - Adult Group The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adults with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health. 12 weeks No
Secondary Change From Baseline in CFQ Scores - Adolescents Group The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents (age 6-13) with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health. 12 weeks No
Secondary Change From Baseline in CFQ Scores - Parent Questionnaire The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents with CF - parent questionnaire. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health. 12 weeks No
Secondary Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss) Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose No
Secondary Maximum Measured Concentration at Steady State (Cmax,ss) Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state. pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose No
Secondary Time From Dosing to the Maximum Concentration (Tmax,ss) Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose No
Secondary Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event. From first drug administration until 30 days after last drug administration (up to 121 days) No
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