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

NCT00737100 | Completed Phase 2 Results

• 2 other identifiers: 205.3392008-001156-43
• Study Type: interventional
• Target: 510
• Locations: 11 countries
• Sites: 107

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

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (12)

• Percent Predicted FVC AUC0-4 Response at the End of Week 12

  Baseline, Week 12

• Percent Predicted FVC Trough Response at the End of Week 12

  Baseline, Week 12

• Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12

  Baseline, Week 12

• Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12

  Baseline, Week 12

• Respiratory and Systemic Symptoms Questionnaire (RSSQ)

  12 weeks

Study Arms (3)

Tiotropium Respimat 2.5 mcg

EXPERIMENTAL

patient to receive low dose tiotropium once daily

Drug: tiotropium bromide-low dose-2.5mcg

Tiotropium Respimat 5 mcg

EXPERIMENTAL

patient to receive high dose tiotropium once daily

Drug: Tiotropium bromide 5 mcg

Placebo Respimat

PLACEBO COMPARATOR

patient to receive placebo once daily

Drug: Placebo Respimat

Interventions

Placebo Respimat DRUG

patient to receive placebo matching active drug once daily

Placebo Respimat

Tiotropium bromide 5 mcg DRUG

patient to recieve high dose tiotropium once daily

Tiotropium Respimat 5 mcg

tiotropium bromide-low dose-2.5mcg DRUG

patient to receive low dose tiotropium once daily

Tiotropium Respimat 2.5 mcg

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients
• Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable mutations)
• Pre-bronchodilator FEV1 greater/equal 25% of predicted values

You may not qualify if:

• Significant history of allergy/hypersensitivity
• Hypersensitivity to study drug
• Participation in another trial
• Female patients who are pregnant or lactating
• Female patients of childbearing potential
• Patients who have started a new medication for CF within 4 weeks of screening
• Patients with known substance abuse
• Clinically significant disease other than CF

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (107)

205.339.006 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

205.339.019 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

205.339.023 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

205.339.021 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

205.339.030 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

205.339.031 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

205.339.014 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

205.339.022 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

205.339.013 Boehringer Ingelheim Investigational Site

South Bend, Indiana, United States

Location

205.339.001 Boehringer Ingelheim Investigational Site

Iowa City, Iowa, United States

Location

205.339.017 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Location

205.339.025 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

205.339.016 Boehringer Ingelheim Investigational Site

Grand Rapids, Michigan, United States

Location

205.339.018 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

Location

205.339.029 Boehringer Ingelheim Investigational Site

Long Branch, New Jersey, United States

Location

205.339.009 Boehringer Ingelheim Investigational Site

Morristown, New Jersey, United States

Location

205.339.002 Boehringer Ingelheim Investigational Site

Syracuse, New York, United States

Location

205.339.024 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Location

205.339.020 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

205.339.032 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

205.339.010 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

205.339.004 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Location

205.339.005 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

205.339.026 Boehringer Ingelheim Investigational Site

Colchester, Vermont, United States

Location

205.339.011 Boehringer Ingelheim Investigational Site

Charlottesville, Virginia, United States

Location

205.339.003 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

Location

205.339.100 Boehringer Ingelheim Investigational Site

Westmead, New South Wales, Australia

Location

205.339.101 Boehringer Ingelheim Investigational Site

Westmead, New South Wales, Australia

Location

205.339.103 Boehringer Ingelheim Investigational Site

Adelaide, South Australia, Australia

Location

205.339.104 Boehringer Ingelheim Investigational Site

Subiaco, Western Australia, Australia

Location

205.339.111 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

205.339.112 Boehringer Ingelheim Investigational Site

Jette, Belgium

Location

205.339.110 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

205.339.3310A Boehringer Ingelheim Investigational Site

Amiens, France

Location

205.339.3317A Boehringer Ingelheim Investigational Site

Angers, France

Location

205.339.3317C Boehringer Ingelheim Investigational Site

Angers, France

Location

205.339.3317D Boehringer Ingelheim Investigational Site

Angers, France

Location

205.339.3317E Boehringer Ingelheim Investigational Site

Angers, France

Location

205.339.3314A Boehringer Ingelheim Investigational Site

Bron, France

Location

205.339.3314B Boehringer Ingelheim Investigational Site

Bron, France

Location

205.339.3314C Boehringer Ingelheim Investigational Site

Bron, France

Location

205.339.3302A Boehringer Ingelheim Investigational Site

Lille, France

Location

205.339.3302B Boehringer Ingelheim Investigational Site

Lille, France

Location

205.339.3302C Boehringer Ingelheim Investigational Site

Lille, France

Location

205.339.3303A Boehringer Ingelheim Investigational Site

Lisieux, France

Location

205.339.3304A Boehringer Ingelheim Investigational Site

Montpellier, France

Location

205.339.3304B Boehringer Ingelheim Investigational Site

Montpellier, France

Location

205.339.3308A Boehringer Ingelheim Investigational Site

Nantes, France

Location

205.339.3308B Boehringer Ingelheim Investigational Site

Nantes, France

Location

205.339.3308C Boehringer Ingelheim Investigational Site

Nantes, France

Location

205.339.3301B Boehringer Ingelheim Investigational Site

Paris, France

Location

205.339.3312A Boehringer Ingelheim Investigational Site

Paris, France

Location

205.339.3312C Boehringer Ingelheim Investigational Site

Paris, France

Location

205.339.3313A Boehringer Ingelheim Investigational Site

Paris, France

Location

205.339.3313B Boehringer Ingelheim Investigational Site

Paris, France

Location

205.339.3318A Boehringer Ingelheim Investigational Site

Rennes, France

Location

205.339.3318C Boehringer Ingelheim Investigational Site

Rennes, France

Location

205.339.3318G Boehringer Ingelheim Investigational Site

Rennes, France

Location

205.339.3315C Boehringer Ingelheim Investigational Site

Roscoff, France

Location

205.339.3315D Boehringer Ingelheim Investigational Site

Roscoff, France

Location

205.339.3306A Boehringer Ingelheim Investigational Site

Rouen, France

Location

205.339.3306B Boehringer Ingelheim Investigational Site

Rouen, France

Location

205.339.3307A Boehringer Ingelheim Investigational Site

Rouen, France

Location

205.339.3309A Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, France

Location

205.339.3316A Boehringer Ingelheim Investigational Site

Vannes, France

Location

205.339.49132 Boehringer Ingelheim Investigational Site

Erlangen, Germany

Location

205.339.49137 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

205.339.49133 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

205.339.49134 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

205.339.49131 Boehringer Ingelheim Investigational Site

Gerlingen, Germany

Location

205.339.49145 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

205.339.49135 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

205.339.49141 Boehringer Ingelheim Investigational Site

Heidelberg, Germany

Location

205.339.49140 Boehringer Ingelheim Investigational Site

München, Germany

Location

205.339.49142 Boehringer Ingelheim Investigational Site

München, Germany

Location

205.339.49130 Boehringer Ingelheim Investigational Site

Tübingen, Germany

Location

205.339.233 Boehringer Ingelheim Investigational Site

Ancona, Italy

Location

205.339.231 Boehringer Ingelheim Investigational Site

Florence, Italy

Location

205.339.234 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

205.339.171 Boehringer Ingelheim Investigational Site

Groesbeek, Netherlands

Location

205.339.170 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

205.339.105 Boehringer Ingelheim Investigational Site

Grafton / Auckland, New Zealand

Location

205.339.106 Boehringer Ingelheim Investigational Site

Hamilton, New Zealand

Location

205.339.221 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

205.339.225 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

205.339.223 Boehringer Ingelheim Investigational Site

Porto, Portugal

Location

205.339.224 Boehringer Ingelheim Investigational Site

Porto, Portugal

Location

205.339.07001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.339.07002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.339.07003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.339.07007 Boehringer Ingelheim Investigational Site

Rostov-on-Don, Russia

Location

205.339.07005 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

205.339.07006 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

205.339.07008 Boehringer Ingelheim Investigational Site

Voronezh, Russia

Location

205.339.07004 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

205.339.44180 Boehringer Ingelheim Investigational Site

Belfast, United Kingdom

Location

205.339.44190 Boehringer Ingelheim Investigational Site

Birmingham, United Kingdom

Location

205.339.44193 Boehringer Ingelheim Investigational Site

Boston, United Kingdom

Location

205.339.44192 Boehringer Ingelheim Investigational Site

Leeds, United Kingdom

Location

205.339.44191 Boehringer Ingelheim Investigational Site

Lincoln, United Kingdom

Location

205.339.44185 Boehringer Ingelheim Investigational Site

Liverpool, United Kingdom

Location

205.339.44186 Boehringer Ingelheim Investigational Site

Liverpool, United Kingdom

Location

205.339.44183 Boehringer Ingelheim Investigational Site

Nottingham, United Kingdom

Location

205.339.44182 Boehringer Ingelheim Investigational Site

Oxford, United Kingdom

Location

205.339.44194 Boehringer Ingelheim Investigational Site

Plymouth, United Kingdom

Location

205.339.44181 Boehringer Ingelheim Investigational Site

Sheffield, United Kingdom

Location

205.339.44184 Boehringer Ingelheim Investigational Site

Wolverhampton, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 25819269 DERIVED

• 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.

  PMID: 25188297 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2010
• Last Updated: May 16, 2014
• Results First Posted: April 13, 2011

Record last verified: 2014-01

Locations

RU (8); FR (32); PT (4); AU (4); IT (3); GB (12); US (26); BE (3); NL (2); DE (11); NZ (2)