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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00347139 |
In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar manner to a study that has already been completed (study number B2C101762) which examined repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data from study B2C101762 and will provide confidence (or not) that the desired bronchodilation can be achieved and maintained without undesirable side effects.
Condition | Intervention | Phase |
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Asthma |
Drug: GW642444 (25, 100 & 400 mcg/day) Drug: salbutamol 50mcg/day |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Four-Way Incomplete Block Crossover Study, to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (25, 100 and 400 Mcg Once Daily) of GW642444 |
Enrollment: | 56 |
Study Start Date: | May 2006 |
Study Completion Date: | January 2007 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Germany, Hessen | |
GSK Investigational Site | |
Wiesbaden, Hessen, Germany, 65187 | |
Germany, Schleswig-Holstein | |
GSK Investigational Site | |
Grosshansdorf, Schleswig-Holstein, Germany, 22927 | |
New Zealand | |
GSK Investigational Site | |
Wellington 6004, New Zealand, 6004 | |
Russian Federation | |
GSK Investigational Site | |
Moscow, Russian Federation, 105 077 | |
Sweden | |
GSK Investigational Site | |
GÖTEBORG, Sweden, SE-413 45 | |
United Kingdom | |
GSK Investigational Site | |
London, United Kingdom, SE5 9RJ |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | B2C106093 |
Study First Received: | June 29, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00347139 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; New Zealand: Health Research Council; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
GW642444 Asthmatic patients Efficacy Safety |
Tolerability Pharmacodynamics Pharmacokinetics |
Naphazoline Oxymetazoline Guaifenesin Phenylephrine |
Albuterol Asthma Phenylpropanolamine |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Adrenergic Agents Physiological Effects of Drugs Anti-Asthmatic Agents Reproductive Control Agents |
Pharmacologic Actions Adrenergic Agonists Tocolytic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |