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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00772538 |
The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined as add-on controller therapy on top of usual care in patients with severe persistent asthma.
The primary objective of each trial is to evaluate the long term efficacy of tiotropium over placebo on top of usual care in patients with severe persistent asthma as determined by pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on asthma control and health care resource utilisation. The secondary objective of each trial is to compare the long term safety of tiotropium with placebo in this patient population.
Condition | Intervention | Phase |
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Asthma |
Drug: tiotropium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (5 Mcg/Day) Over 48 Weeks as Add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma |
Estimated Enrollment: | 316 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Note:
As with other anticholinergic drugs, tiotropium should be used with caution in patients with prostatic hyperplasia or bladder neck obstruction.
As with all predominantly renally excreted drugs, patients with moderate to severe renal impairment (known creatinine clearance of <= 50 mL/min) treated with tiotropium should be monitored closely.
Contact: Boehringer Ingelheim Study Coordinator | 800-542-6257 ext Option 4 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 205.416, EudraCT no. 2008-001413-14 |
Study First Received: | October 13, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00772538 |
Health Authority: | Australia: Responsilble Ethics Committee; Canada: Therapeutic Products Directorate; Denmark: The Danish Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Great Britain: MHRA; Italy: Comitato Etico per la Sperimentazione Clinica dei Medicinali dell'A.O. Univ. Pisana di Pisa; Netherlands: Central Committee on Research Involving Human Subjects (CCMO); Russia: Ministry of Health Care and Social Progress of Russian Federation; Serbia / Yugoslavia: Medicines and Medical Devices Agency of Serbia, 11152 Belgrade; South Africa: Medicines Control Council; Turkey: Ministry of Health Central Ethics Committee; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Tiotropium Respiratory Hypersensitivity |
Respiratory System Agents Parasympatholytics Neurotransmitter Agents Bronchial Diseases Immune System Diseases Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Anti-Asthmatic Agents Cholinergic Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |