An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00365560
First received: August 16, 2006
Last updated: May 18, 2012
Last verified: May 2012
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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 wi |
Resource links provided by NLM:
MedlinePlus related topics:
Asthma
Drug Information available for:
Tiotropium bromide
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:
No publications provided by Boehringer Ingelheim Pharmaceuticals
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: | May 18, 2012 |
| 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 May 19, 2013