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

NCT ID: NCT00737100

Last Updated: 2014-05-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Tiotropium Respimat 2.5 mcg

patient to receive low dose tiotropium once daily

Group Type EXPERIMENTAL

tiotropium bromide-low dose-2.5mcg

Intervention Type DRUG

patient to receive low dose tiotropium once daily

Tiotropium Respimat 5 mcg

patient to receive high dose tiotropium once daily

Group Type EXPERIMENTAL

Tiotropium bromide 5 mcg

Intervention Type DRUG

patient to recieve high dose tiotropium once daily

Placebo Respimat

patient to receive placebo once daily

Group Type PLACEBO_COMPARATOR

Placebo Respimat

Intervention Type DRUG

patient to receive placebo matching active drug once daily

Interventions

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Placebo Respimat

patient to receive placebo matching active drug once daily

Intervention Type DRUG

Tiotropium bromide 5 mcg

patient to recieve high dose tiotropium once daily

Intervention Type DRUG

tiotropium bromide-low dose-2.5mcg

patient to receive low dose tiotropium once daily

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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205.339.006 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Site Status

205.339.019 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

205.339.023 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Site Status

205.339.021 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

205.339.030 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Site Status

205.339.031 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Site Status

205.339.014 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Site Status

205.339.022 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Site Status

205.339.013 Boehringer Ingelheim Investigational Site

South Bend, Indiana, United States

Site Status

205.339.001 Boehringer Ingelheim Investigational Site

Iowa City, Iowa, United States

Site Status

205.339.017 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Site Status

205.339.025 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Site Status

205.339.016 Boehringer Ingelheim Investigational Site

Grand Rapids, Michigan, United States

Site Status

205.339.018 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

Site Status

205.339.029 Boehringer Ingelheim Investigational Site

Long Branch, New Jersey, United States

Site Status

205.339.009 Boehringer Ingelheim Investigational Site

Morristown, New Jersey, United States

Site Status

205.339.002 Boehringer Ingelheim Investigational Site

Syracuse, New York, United States

Site Status

205.339.024 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Site Status

205.339.020 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

205.339.032 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

205.339.010 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

205.339.004 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Site Status

205.339.005 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Site Status

205.339.026 Boehringer Ingelheim Investigational Site

Colchester, Vermont, United States

Site Status

205.339.011 Boehringer Ingelheim Investigational Site

Charlottesville, Virginia, United States

Site Status

205.339.003 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

Site Status

205.339.100 Boehringer Ingelheim Investigational Site

Westmead, New South Wales, Australia

Site Status

205.339.101 Boehringer Ingelheim Investigational Site

Westmead, New South Wales, Australia

Site Status

205.339.103 Boehringer Ingelheim Investigational Site

Adelaide, South Australia, Australia

Site Status

205.339.104 Boehringer Ingelheim Investigational Site

Subiaco, Western Australia, Australia

Site Status

205.339.111 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

205.339.112 Boehringer Ingelheim Investigational Site

Jette, , Belgium

Site Status

205.339.110 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

Site Status

205.339.3310A Boehringer Ingelheim Investigational Site

Amiens, , France

Site Status

205.339.3317A Boehringer Ingelheim Investigational Site

Angers, , France

Site Status

205.339.3317C Boehringer Ingelheim Investigational Site

Angers, , France

Site Status

205.339.3317D Boehringer Ingelheim Investigational Site

Angers, , France

Site Status

205.339.3317E Boehringer Ingelheim Investigational Site

Angers, , France

Site Status

205.339.3314A Boehringer Ingelheim Investigational Site

Bron, , France

Site Status

205.339.3314B Boehringer Ingelheim Investigational Site

Bron, , France

Site Status

205.339.3314C Boehringer Ingelheim Investigational Site

Bron, , France

Site Status

205.339.3302A Boehringer Ingelheim Investigational Site

Lille, , France

Site Status

205.339.3302B Boehringer Ingelheim Investigational Site

Lille, , France

Site Status

205.339.3302C Boehringer Ingelheim Investigational Site

Lille, , France

Site Status

205.339.3303A Boehringer Ingelheim Investigational Site

Lisieux, , France

Site Status

205.339.3304A Boehringer Ingelheim Investigational Site

Montpellier, , France

Site Status

205.339.3304B Boehringer Ingelheim Investigational Site

Montpellier, , France

Site Status

205.339.3308A Boehringer Ingelheim Investigational Site

Nantes, , France

Site Status

205.339.3308B Boehringer Ingelheim Investigational Site

Nantes, , France

Site Status

205.339.3308C Boehringer Ingelheim Investigational Site

Nantes, , France

Site Status

205.339.3301B Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

205.339.3312A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

205.339.3312C Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

205.339.3313A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

205.339.3313B Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

205.339.3318A Boehringer Ingelheim Investigational Site

Rennes, , France

Site Status

205.339.3318C Boehringer Ingelheim Investigational Site

Rennes, , France

Site Status

205.339.3318G Boehringer Ingelheim Investigational Site

Rennes, , France

Site Status

205.339.3315C Boehringer Ingelheim Investigational Site

Roscoff, , France

Site Status

205.339.3315D Boehringer Ingelheim Investigational Site

Roscoff, , France

Site Status

205.339.3306A Boehringer Ingelheim Investigational Site

Rouen, , France

Site Status

205.339.3306B Boehringer Ingelheim Investigational Site

Rouen, , France

Site Status

205.339.3307A Boehringer Ingelheim Investigational Site

Rouen, , France

Site Status

205.339.3309A Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, , France

Site Status

205.339.3316A Boehringer Ingelheim Investigational Site

Vannes, , France

Site Status

205.339.49132 Boehringer Ingelheim Investigational Site

Erlangen, , Germany

Site Status

205.339.49137 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

205.339.49133 Boehringer Ingelheim Investigational Site

Frankfurt am Main, , Germany

Site Status

205.339.49134 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

Site Status

205.339.49131 Boehringer Ingelheim Investigational Site

Gerlingen, , Germany

Site Status

205.339.49145 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

205.339.49135 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

205.339.49141 Boehringer Ingelheim Investigational Site

Heidelberg, , Germany

Site Status

205.339.49140 Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

205.339.49142 Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

205.339.49130 Boehringer Ingelheim Investigational Site

Tübingen, , Germany

Site Status

205.339.233 Boehringer Ingelheim Investigational Site

Ancona, , Italy

Site Status

205.339.231 Boehringer Ingelheim Investigational Site

Florence, , Italy

Site Status

205.339.234 Boehringer Ingelheim Investigational Site

Genova, , Italy

Site Status

205.339.171 Boehringer Ingelheim Investigational Site

Groesbeek, , Netherlands

Site Status

205.339.170 Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

Site Status

205.339.105 Boehringer Ingelheim Investigational Site

Grafton / Auckland, , New Zealand

Site Status

205.339.106 Boehringer Ingelheim Investigational Site

Hamilton, , New Zealand

Site Status

205.339.221 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

205.339.225 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

205.339.223 Boehringer Ingelheim Investigational Site

Porto, , Portugal

Site Status

205.339.224 Boehringer Ingelheim Investigational Site

Porto, , Portugal

Site Status

205.339.07001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

205.339.07002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

205.339.07003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

205.339.07007 Boehringer Ingelheim Investigational Site

Rostov-on-Don, , Russia

Site Status

205.339.07005 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

205.339.07006 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

205.339.07008 Boehringer Ingelheim Investigational Site

Voronezh, , Russia

Site Status

205.339.07004 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

Site Status

205.339.44180 Boehringer Ingelheim Investigational Site

Belfast, , United Kingdom

Site Status

205.339.44190 Boehringer Ingelheim Investigational Site

Birmingham, , United Kingdom

Site Status

205.339.44193 Boehringer Ingelheim Investigational Site

Boston, , United Kingdom

Site Status

205.339.44192 Boehringer Ingelheim Investigational Site

Leeds, , United Kingdom

Site Status

205.339.44191 Boehringer Ingelheim Investigational Site

Lincoln, , United Kingdom

Site Status

205.339.44185 Boehringer Ingelheim Investigational Site

Liverpool, , United Kingdom

Site Status

205.339.44186 Boehringer Ingelheim Investigational Site

Liverpool, , United Kingdom

Site Status

205.339.44183 Boehringer Ingelheim Investigational Site

Nottingham, , United Kingdom

Site Status

205.339.44182 Boehringer Ingelheim Investigational Site

Oxford, , United Kingdom

Site Status

205.339.44194 Boehringer Ingelheim Investigational Site

Plymouth, , United Kingdom

Site Status

205.339.44181 Boehringer Ingelheim Investigational Site

Sheffield, , United Kingdom

Site Status

205.339.44184 Boehringer Ingelheim Investigational Site

Wolverhampton, , United Kingdom

Site Status

Countries

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United States Australia Belgium France Germany Italy Netherlands New Zealand Portugal Russia United Kingdom

References

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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.

Reference Type DERIVED
PMID: 25819269 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25188297 (View on PubMed)

Other Identifiers

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2008-001156-43

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205.339

Identifier Type: -

Identifier Source: org_study_id

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