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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01179347




Registration number
NCT01179347
Ethics application status
Date submitted
10/08/2010
Date registered
11/08/2010
Date last updated
24/12/2013

Titles & IDs
Public title
Tiotropium Bromide in Cystic Fibrosis
Scientific title
A Randomised, Double-blind, Placebo-controlled Parallel-group Trial to Confirm the Efficacy After 12 Weeks and the Safety of Tiotropium 5 Mcg Administered Once Daily Via the Respimat® Device in Patients With Cystic Fibrosis.
Secondary ID [1] 0 0
2010-019802-17
Secondary ID [2] 0 0
205.438
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
Description of intervention(s) / exposure
Treatment: Drugs - tiotropium Respimat® inhaler
Treatment: Drugs - Placebo Respimat® inhaler

Experimental: tiotropium - 2 inhalations once daily delivered with Respimat® inhaler

Placebo comparator: placebo - 2 inhalations once daily delivered with Respimat® inhaler


Treatment: Drugs: tiotropium Respimat® inhaler
to evaluate safety and efficacy tiotropium delivered with Respimat® inhaler compared to placebo.

Treatment: Drugs: Placebo Respimat® inhaler
patient to receive placebo matching active drug once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
Trough FEV1 Response
Timepoint [2] 0 0
Baseline and 12 weeks
Secondary outcome [1] 0 0
Forced Vital Capacity (FVC) Area Under the Curve 0-4 Hours (AUC0-4h) Response
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Trough FVC Response
Timepoint [2] 0 0
Baseline and 12 weeks
Secondary outcome [3] 0 0
Pre-bronchodilator Forced Expiratory Flow Between 25 Percent and 75 Percent of the FVC (FEF25-75) Response
Timepoint [3] 0 0
Baseline and 12 weeks
Secondary outcome [4] 0 0
Percentage of Participants With at Least 1 Pulmonary Exacerbation During Double-blind Treatment
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Change From Baseline in Revised Cystic Fibrosis Questionnaire (CFQ-R) Score
Timepoint [5] 0 0
Baseline and 12 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Patients with a documented diagnosis of Cystic Fibrosis (CF) (positive sweat chloride >=60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations.
2. Male or female patients (children less than 12 years and adolescents >12 years).
3. Patients >=5 years of age must be able to perform acceptable spirometric maneuvers, according to the American Thoracic Society (ATS) standards.
4. Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) >25% of predicted values.
5. Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1.
6. No evidence of respiratory tract infection and no pulmonary exacerbation requiring use of intravenous/oral/inhaled antibiotics, or oral corticosteroids within 2 weeks of screening.
7. The patient or the patient's legally acceptable representative must be able to give informed consent.
8. Patients who are on a cycling TOBI® regimen must have completed at least 2 cycles every other month TOBI® administration prior to the screening visit.
9. Patients who are on daily inhaled antibiotic use must be stabilized for at least 6 weeks prior to Visit 1 (screening).
10. Patients having previously participated in study 205.339 can also be selected.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Patients with a known hypersensitivity to study drug
2. Patients who have participated in another study with an Investigational drug within one month preceding the screening visit.
3. Patients who are currently participating in another trial. Observational studies are allowed. Permission should be obtained from sponsor of other study.
4. Patients with known relevant substance abuse, including alcohol or drug abuse.
5. Adolescent and adult female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening.
6. Female patients of child bearing potential who are not using a medically approved form of contraception.
7. Clinically significant disease or medical condition other than CF or CF-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. Patients with diabetes may participate if their disease is under good control prior to screening.

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 3
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
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
464
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
205.438.61003 Boehringer Ingelheim Investigational Site - Chermside
Recruitment hospital [2] 0 0
205.438.61004 Boehringer Ingelheim Investigational Site - Herston
Recruitment hospital [3] 0 0
205.438.61001 Boehringer Ingelheim Investigational Site - Adelaide
Recruitment hospital [4] 0 0
205.438.61002 Boehringer Ingelheim Investigational Site - Subiaco
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
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United States of America
State/province [4] 0 0
Indiana
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United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New Hampshire
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Austria
State/province [12] 0 0
Innsbruck
Country [13] 0 0
Austria
State/province [13] 0 0
Salzburg
Country [14] 0 0
Belgium
State/province [14] 0 0
Bruxelles
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Jette
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Nova Scotia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Brno
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Olomouc
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Czech Republic
State/province [25] 0 0
Prague 5
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France
State/province [26] 0 0
Angers
Country [27] 0 0
France
State/province [27] 0 0
BRON Cedex
Country [28] 0 0
France
State/province [28] 0 0
Lille Cedex
Country [29] 0 0
France
State/province [29] 0 0
Lisieux
Country [30] 0 0
France
State/province [30] 0 0
Montpellier
Country [31] 0 0
France
State/province [31] 0 0
Nantes
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France
State/province [32] 0 0
Nice Cedex 1
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France
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Paris
Country [34] 0 0
France
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Rennes
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France
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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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Vannes
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Germany
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Bochum
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Germany
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Frankfurt/Main
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Germany
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Frankfurt
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Germany
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Gerlingen
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Germany
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Gießen
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Germany
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Hamburg
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Germany
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München
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Germany
State/province [45] 0 0
Tübingen
Country [46] 0 0
Hungary
State/province [46] 0 0
Budapest
Country [47] 0 0
Hungary
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Mosdos
Country [48] 0 0
Hungary
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Szeged
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Ireland
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Dublin 12
Country [50] 0 0
Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Tel Hashomer
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Italy
State/province [54] 0 0
Firenze
Country [55] 0 0
Italy
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Genova
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Italy
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Verona
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Poland
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Lodz
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Poland
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Rabka Zdroj
Country [59] 0 0
Poland
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Warszawa
Country [60] 0 0
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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Russian Federation
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St. Petersburg
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Russian Federation
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Voronezh
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Yaroslavl
Country [66] 0 0
Slovakia
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Banska Bystrica
Country [67] 0 0
Slovakia
State/province [67] 0 0
Bratislava
Country [68] 0 0
Slovakia
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Kosice
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South Africa
State/province [69] 0 0
Cape Town
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Spain
State/province [70] 0 0
Barcelona
Country [71] 0 0
Spain
State/province [71] 0 0
Madrid
Country [72] 0 0
Spain
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Valencia
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Switzerland
State/province [73] 0 0
Basel
Country [74] 0 0
Switzerland
State/province [74] 0 0
Bern 4
Country [75] 0 0
Switzerland
State/province [75] 0 0
Zürich
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Brighton
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Cambridge
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Leeds
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United Kingdom
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Nottingham
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Plymouth
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Sheffield

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01179347