Clinical trial NCT00737100: Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 510
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Percent Predicted FEV1 AUC0-4 Response at the End of Week 12
timeFrame: Baseline, Week 12
measure: Percent Predicted FEV1 Trough Response at the End of Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percent Predicted FVC AUC0-4 Response at the End of Week 12
timeFrame: Baseline, Week 12
measure: Percent Predicted FVC Trough Response at the End of Week 12
timeFrame: Baseline, Week 12
measure: Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12
timeFrame: Baseline, Week 12
measure: Respiratory and Systemic Symptoms Questionnaire (RSSQ)
timeFrame: 12 weeks
measure: Change From Baseline in CFQ Scores - Adult Group
timeFrame: 12 weeks
measure: Change From Baseline in CFQ Scores - Adolescents Group
timeFrame: 12 weeks
measure: Change From Baseline in CFQ Scores - Parent Questionnaire
timeFrame: 12 weeks
measure: Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)
timeFrame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
measure: Maximum Measured Concentration at Steady State (Cmax,ss)
timeFrame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
measure: Time From Dosing to the Maximum Concentration (Tmax,ss)
timeFrame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
measure: Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation
timeFrame: From first drug administration until 30 days after last drug administration (up to 121 days)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: 205.339.006 Boehringer Ingelheim Investigational Site
state: Arizona
city: San Diego
country: United States
facility: 205.339.019 Boehringer Ingelheim Investigational Site
state: California
city: Jacksonville
country: United States
facility: 205.339.023 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 205.339.021 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 205.339.030 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 205.339.031 Boehringer Ingelheim Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: 205.339.014 Boehringer Ingelheim Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: 205.339.022 Boehringer Ingelheim Investigational Site
state: Indiana
city: South Bend
country: United States
facility: 205.339.013 Boehringer Ingelheim Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: 205.339.001 Boehringer Ingelheim Investigational Site
state: Iowa
city: Ann Arbor
country: United States
facility: 205.339.017 Boehringer Ingelheim Investigational Site
state: Michigan
city: Detroit
country: United States
facility: 205.339.025 Boehringer Ingelheim Investigational Site
state: Michigan
city: Grand Rapids
country: United States
facility: 205.339.016 Boehringer Ingelheim Investigational Site
state: Michigan
city: Lebanon
country: United States
facility: 205.339.018 Boehringer Ingelheim Investigational Site
state: New Hampshire
city: Long Branch
country: United States
facility: 205.339.029 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Morristown
country: United States
facility: 205.339.009 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Syracuse
country: United States
facility: 205.339.002 Boehringer Ingelheim Investigational Site
state: New York
city: Cleveland
country: United States
facility: 205.339.024 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 205.339.020 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: 205.339.032 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Charleston
country: United States
facility: 205.339.010 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Fort Worth
country: United States
facility: 205.339.004 Boehringer Ingelheim Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: 205.339.005 Boehringer Ingelheim Investigational Site
state: Utah
city: Colchester
country: United States
facility: 205.339.026 Boehringer Ingelheim Investigational Site
state: Vermont
city: Charlottesville
country: United States
facility: 205.339.011 Boehringer Ingelheim Investigational Site
state: Virginia
city: Milwaukee
country: United States
facility: 205.339.003 Boehringer Ingelheim Investigational Site
state: Wisconsin
city: Westmead
country: Australia
facility: 205.339.100 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: 205.339.101 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Adelaide
country: Australia
facility: 205.339.103 Boehringer Ingelheim Investigational Site
state: South Australia
city: Subiaco
country: Australia
facility: 205.339.104 Boehringer Ingelheim Investigational Site
state: Western Australia
city: Bruxelles
country: Belgium
facility: 205.339.111 Boehringer Ingelheim Investigational Site
city: Jette
country: Belgium
facility: 205.339.112 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 205.339.110 Boehringer Ingelheim Investigational Site
city: Amiens
country: France
facility: 205.339.3310A Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 205.339.3317A Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 205.339.3317C Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 205.339.3317D Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 205.339.3317E Boehringer Ingelheim Investigational Site
city: BRON Cedex
country: France
facility: 205.339.3314A Boehringer Ingelheim Investigational Site
city: BRON Cedex
country: France
facility: 205.339.3314B Boehringer Ingelheim Investigational Site
city: BRON Cedex
country: France
facility: 205.339.3314C Boehringer Ingelheim Investigational Site
city: Lille Cedex
country: France
facility: 205.339.3302A Boehringer Ingelheim Investigational Site
city: Lille Cedex
country: France
facility: 205.339.3302C Boehringer Ingelheim Investigational Site
city: Lille
country: France
facility: 205.339.3302B Boehringer Ingelheim Investigational Site
city: Lisieux
country: France
facility: 205.339.3303A Boehringer Ingelheim Investigational Site
city: Montpellier
country: France
facility: 205.339.3304A Boehringer Ingelheim Investigational Site
city: Montpellier
country: France
facility: 205.339.3304B Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 205.339.3308A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 205.339.3308B Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 205.339.3308C Boehringer Ingelheim Investigational Site
city: Paris Cedex 14
country: France
facility: 205.339.3301B Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 205.339.3312A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 205.339.3312C Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 205.339.3313A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 205.339.3313B Boehringer Ingelheim Investigational Site
city: Rennes
country: France
facility: 205.339.3318A Boehringer Ingelheim Investigational Site
city: Rennes
country: France
facility: 205.339.3318C Boehringer Ingelheim Investigational Site
city: Rennes
country: France
facility: 205.339.3318G Boehringer Ingelheim Investigational Site
city: Roscoff Cedex
country: France
facility: 205.339.3315C Boehringer Ingelheim Investigational Site
city: Roscoff Cedex
country: France
facility: 205.339.3315D Boehringer Ingelheim Investigational Site
city: Rouen cedex
country: France
facility: 205.339.3306A Boehringer Ingelheim Investigational Site
city: Rouen cedex
country: France
facility: 205.339.3306B Boehringer Ingelheim Investigational Site
city: Rouen cedex
country: France
facility: 205.339.3307A Boehringer Ingelheim Investigational Site
city: Vandoeuvre les Nancy
country: France
facility: 205.339.3309A Boehringer Ingelheim Investigational Site
city: Vannes
country: France
facility: 205.339.3316A Boehringer Ingelheim Investigational Site
city: Erlangen
country: Germany
facility: 205.339.49132 Boehringer Ingelheim Investigational Site
city: Frankfurt/Main
country: Germany
facility: 205.339.49133 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 205.339.49137 Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: 205.339.49134 Boehringer Ingelheim Investigational Site
city: Gerlingen
country: Germany
facility: 205.339.49131 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 205.339.49145 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 205.339.49135 Boehringer Ingelheim Investigational Site
city: Heidelberg
country: Germany
facility: 205.339.49141 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 205.339.49140 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 205.339.49142 Boehringer Ingelheim Investigational Site
city: Tübingen
country: Germany
facility: 205.339.49130 Boehringer Ingelheim Investigational Site
city: Ancona
country: Italy
facility: 205.339.233 Boehringer Ingelheim Investigational Site
city: Firenze
country: Italy
facility: 205.339.231 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 205.339.234 Boehringer Ingelheim Investigational Site
city: Groesbeek
country: Netherlands
facility: 205.339.171 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 205.339.170 Boehringer Ingelheim Investigational Site
city: Grafton / Auckland
country: New Zealand
facility: 205.339.105 Boehringer Ingelheim Investigational Site
city: Hamilton
country: New Zealand
facility: 205.339.106 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 205.339.221 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 205.339.225 Boehringer Ingelheim Investigational Site
city: Porto
country: Portugal
facility: 205.339.223 Boehringer Ingelheim Investigational Site
city: Porto
country: Portugal
facility: 205.339.224 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 205.339.07001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 205.339.07002 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 205.339.07003 Boehringer Ingelheim Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: 205.339.07007 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 205.339.07005 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 205.339.07006 Boehringer Ingelheim Investigational Site
city: Voronezh
country: Russian Federation
facility: 205.339.07008 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 205.339.07004 Boehringer Ingelheim Investigational Site
city: Belfast
country: United Kingdom
facility: 205.339.44180 Boehringer Ingelheim Investigational Site
city: Birmingham
country: United Kingdom
facility: 205.339.44190 Boehringer Ingelheim Investigational Site
city: Boston
country: United Kingdom
facility: 205.339.44193 Boehringer Ingelheim Investigational Site
city: Leeds
country: United Kingdom
facility: 205.339.44192 Boehringer Ingelheim Investigational Site
city: Lincoln
country: United Kingdom
facility: 205.339.44191 Boehringer Ingelheim Investigational Site
city: Liverpool
country: United Kingdom
facility: 205.339.44185 Boehringer Ingelheim Investigational Site
city: Liverpool
country: United Kingdom
facility: 205.339.44186 Boehringer Ingelheim Investigational Site
city: Nottingham
country: United Kingdom
facility: 205.339.44183 Boehringer Ingelheim Investigational Site
city: Oxford
country: United Kingdom
facility: 205.339.44182 Boehringer Ingelheim Investigational Site
city: Plymouth
country: United Kingdom
facility: 205.339.44194 Boehringer Ingelheim Investigational Site
city: Sheffield
country: United Kingdom
facility: 205.339.44181 Boehringer Ingelheim Investigational Site
city: Wolverhampton
country: United Kingdom
facility: 205.339.44184 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Ratjen F, Koker P, Geller DE, Langellier-Cocteaux B, Le Maulf F, Kattenbeck S, Moroni-Zentgraf P, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Tiotropium Respimat in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials. J Cyst Fibros. 2015 Sep;14(5):608-14. doi: 10.1016/j.jcf.2015.03.004. Epub 2015 Mar 26.
citation: Bradley JM, Koker P, Deng Q, Moroni-Zentgraf P, Ratjen F, Geller DE, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Testing two different doses of tiotropium Respimat(R) in cystic fibrosis: phase 2 randomized trial results. PLoS One. 2014 Sep 4;9(9):e106195. doi: 10.1371/journal.pone.0106195. eCollection 2014.