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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00365560
First received: August 16, 2006
Last updated: July 10, 2013
Last verified: July 2013
  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 2

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 With Severe Persistent Asthma

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00365560     History of Changes
Other Study ID Numbers: 205.341
Study First Received: August 16, 2006
Last Updated: July 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Tiotropium
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014