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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00737100




Registration number
NCT00737100
Ethics application status
Date submitted
15/08/2008
Date registered
18/08/2008
Date last updated
16/05/2014

Titles & IDs
Public title
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
Scientific 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.
Secondary ID [1] 0 0
2008-001156-43
Secondary ID [2] 0 0
205.339
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Placebo Respimat
Treatment: Drugs - Tiotropium bromide 5 mcg
Treatment: Drugs - tiotropium bromide-low dose-2.5mcg

Experimental: Tiotropium Respimat 2.5 mcg - patient to receive low dose tiotropium once daily

Experimental: Tiotropium Respimat 5 mcg - patient to receive high dose tiotropium once daily

Placebo comparator: Placebo Respimat - patient to receive placebo once daily


Treatment: Drugs: Placebo Respimat
patient to receive placebo matching active drug once daily

Treatment: Drugs: Tiotropium bromide 5 mcg
patient to recieve high dose tiotropium once daily

Treatment: Drugs: tiotropium bromide-low dose-2.5mcg
patient to receive low dose tiotropium once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Predicted FEV1 AUC0-4 Response at the End of Week 12
Timepoint [1] 0 0
Baseline, Week 12
Primary outcome [2] 0 0
Percent Predicted FEV1 Trough Response at the End of Week 12
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Percent Predicted FVC AUC0-4 Response at the End of Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Percent Predicted FVC Trough Response at the End of Week 12
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
Respiratory and Systemic Symptoms Questionnaire (RSSQ)
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Change From Baseline in CFQ Scores - Adult Group
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Change From Baseline in CFQ Scores - Adolescents Group
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Change From Baseline in CFQ Scores - Parent Questionnaire
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)
Timepoint [9] 0 0
pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Secondary outcome [10] 0 0
Maximum Measured Concentration at Steady State (Cmax,ss)
Timepoint [10] 0 0
pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Secondary outcome [11] 0 0
Time From Dosing to the Maximum Concentration (Tmax,ss)
Timepoint [11] 0 0
pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Secondary outcome [12] 0 0
Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation
Timepoint [12] 0 0
From first drug administration until 30 days after last drug administration (up to 121 days)

Eligibility
Key inclusion 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
510
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
205.339.100 Boehringer Ingelheim Investigational Site - Westmead
Recruitment hospital [2] 0 0
205.339.101 Boehringer Ingelheim Investigational Site - Westmead
Recruitment hospital [3] 0 0
205.339.103 Boehringer Ingelheim Investigational Site - Adelaide
Recruitment hospital [4] 0 0
205.339.104 Boehringer Ingelheim Investigational Site - Subiaco
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Subiaco
Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Indiana
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Iowa
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Michigan
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New Hampshire
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New Jersey
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New York
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Ohio
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Oklahoma
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South Carolina
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Texas
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Utah
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Vermont
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Virginia
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Wisconsin
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Belgium
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Bruxelles
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Belgium
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Jette
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Belgium
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Leuven
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France
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Amiens
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France
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Angers
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France
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BRON Cedex
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France
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Lille Cedex
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France
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Lille
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Lisieux
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France
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Montpellier
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France
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Nantes
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Paris Cedex 14
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France
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Paris
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Rennes
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Roscoff Cedex
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France
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Rouen cedex
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France
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Vandoeuvre les Nancy
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France
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Vannes
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Germany
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Erlangen
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Germany
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Frankfurt/Main
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Frankfurt
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Freiburg
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Germany
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Gerlingen
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Hamburg
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Hannover
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Heidelberg
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Germany
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München
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Germany
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Tübingen
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Italy
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Ancona
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Italy
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Firenze
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Italy
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Genova
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Netherlands
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Groesbeek
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Netherlands
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Rotterdam
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New Zealand
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Grafton / Auckland
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New Zealand
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Hamilton
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Portugal
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Lisboa
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Portugal
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Porto
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Russian Federation
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Moscow
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Rostov-on-Don
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St. Petersburg
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Voronezh
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Russian Federation
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Yaroslavl
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United Kingdom
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Belfast
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Birmingham
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Boston
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Leeds
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Lincoln
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Liverpool
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Nottingham
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Oxford
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Plymouth
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Sheffield
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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT00737100
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00737100