An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma

This study has been completed.

First Received on August 16, 2006. Last Updated on August 17, 2011 History of Changes

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00365560

Purpose

The primary objective of this study is to examine efficacy and safety of tiotropium compared to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification

Condition	Intervention	Phase
Asthma	Drug: tiotropium Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomised, Double-Blind, Placebo-Controlled, Crossover Efficacy and Safety Evaluation of 8-Week Treatment Periods of Two Doses [5 Mcg (2 Actuations of 2.5 Mcg) and 10 Mcg (2 Actuations of 5 Mcg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler? as Add-on Therapy in Patients wi

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Tiotropium bromide Tiotropium

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary efficacy endpoint is the FEV1 response (within 3 hours post dosing) determined at the end of the 8-week treatment period

Secondary Outcome Measures:

FEV1 and FVC AUC 0-3h (in a subset 0-24h) PEF, use of rescue medication, daytime and nocturnal symptoms etc.

Estimated Enrollment:	115
Study Start Date:	August 2006
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Outpatients of either sex, age 18 - 75 years, with at least a documented 5 year history of asthma, and a current diagnosis of severe, persistent asthma (GINA step 4), smoking history < 10 pack years and >= 1 year smoking cessation; Patients must be symptomatic

Exclusion Criteria:

Patients

with a recent history (i.e., six months or less) of myocardial infarction,
who have been hospitalized for heart failure (NYHA class III or IV) within the past year,
with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year,
with malignancy for which the patient has undergone resection, radiation ther apy or chemotherapy within the last five years,
who have undergone thoracotomy with pulmonary resection,
with moderate to severe renal impairment (creatinine clearance = 50 mL/min)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365560

Locations

Denmark
Boehringer Ingelheim Investigational Site
Aalborg, Denmark
Boehringer Ingelheim Investigational Site
Aarhus C, Denmark
Boehringer Ingelheim Investigational Site
Hvidovre, Denmark
Boehringer Ingelheim Investigational Site
K?benhavn NV, Denmark
Boehringer Ingelheim Investigational Site
Odense C, Denmark
Germany
Boehringer Ingelheim Investigational Site
Gelnhausen, Germany
Boehringer Ingelheim Investigational Site
Gro?hansdorf, Germany
Boehringer Ingelheim Investigational Site
Rudersdorf, Germany
Boehringer Ingelheim Investigational Site
Wiesbaden, Germany
Boehringer Ingelheim Investigational Site
Wiesloch, Germany
Netherlands
lokatie Langendijk
Breda, Netherlands
Polikliniek longziekten
Eindhoven, Netherlands
Polikliniek longziekten
Groningen, Netherlands
Polikliniek Longziekten
Heerlen, Netherlands
Polikliniek longziekten
Hengelo, Netherlands
lokatie het Spittaal
Zutphen, Netherlands

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Boehringer Ingelheim Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kerstjens HA, Disse B, Schröder-Babo W, Bantje TA, Gahlemann M, Sigmund R, Engel M, van Noord JA. Tiotropium improves lung function in patients with severe uncontrolled asthma: a randomized controlled trial. J Allergy Clin Immunol. 2011 Aug;128(2):308-14. Epub 2011 Jun 2.

ClinicalTrials.gov Identifier:	NCT00365560 History of Changes
Other Study ID Numbers:	205.341
Study First Received:	August 16, 2006
Last Updated:	August 17, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tiotropium
Parasympatholytics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012