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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00350207 |
This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-contro lled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to s almeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16t h amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in pe riod 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 salmetero l twice daily administered from the HFA-MDI, or placebo twice daily. After the 16 week treatment per iod all patients will receive salmeterol MDI twice daily for four weeks. The patients perform daily morning and evening peak flow and FEV1 measurements with an electronic pe ak flow meter throughout the study. Daily data on asthma control and use of rescue medication are re corded using an electronic diary included in the electronic peak flow meter. On study visits the Min i-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and FVC) are performed.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Tiotropium bromide Drug: Placebo Drug: Salmeterol xinafoate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
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) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 205.342 |
Study First Received: | July 7, 2006 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00350207 |
Health Authority: | Russia: Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; Austria: Federal Office for Safety in Health Care; Belgium: Federal Agency for Medicines and Health Products; Denmark: Danish Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Medicines and Healthcare Products Agency; France: French Health Products Safety Agency (AFSSAPS); Greece: EOF-National Organisation for Medicines; Italy: Committee for the clinical experimentation of drug - Company Hospital University Pisana; Finland: National Agency for Medicines; Turkey: Ministry of Health Central Ethics Committee; Great Britain: MHRA; South Africa: Medicines Control Council |
Hypersensitivity Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases Bromides |
Lung Diseases Hypersensitivity, Immediate Asthma Tiotropium Respiratory Hypersensitivity |
Respiratory System Agents Parasympatholytics Neurotransmitter Agents Adrenergic Agents Adrenergic beta-Agonists Bronchial Diseases Immune System Diseases Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Anti-Asthmatic Agents Cholinergic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |