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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00350207 |
Purpose
This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.
The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Tiotropium bromide Drug: Placebo Drug: Salmeterol xinafoate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype |
| Enrollment: | 388 |
| Study Start Date: | July 2006 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion_Criteria:
Exclusion_Criteria:
Contacts and Locations
Show 109 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00350207 History of Changes |
| Other Study ID Numbers: | 205.342 |
| Study First Received: | July 7, 2006 |
| Results First Received: | August 24, 2009 |
| Last Updated: | November 20, 2009 |
| Health Authority: | Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicines and Health Products Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: French Health Products Safety Agency (AFSSAPS) Germany: Federal Institute for Drugs and Medical Devices Great Britain: MHRA Greece: EOF-National Organisation for Medicines Italy: Committee for the clinical experimentation of drug - Company Hospital University Pisana Russia: Ministry of Health and Social Development of the Russian Federation Slovakia: State Institute for Drug Control South Africa: Medicines Control Council Spain: Spanish Medicines and Healthcare Products Agency Turkey: Ministry of Health Central Ethics Committee United States: Food and Drug Administration |
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Bromides Salmeterol Albuterol Tiotropium Anticonvulsants Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Tocolytic Agents |