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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00702910 |
This study will involve the use of a new medicine called GW642444 being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the study is to see how safe and how well tolerated the study drug is when inhaled in two different formulations as a fine powder by asthmatic patients. In addition, the study is designed to examine the effect of the study drug on the lungs, how the study drug affects parts of the body other than the lungs and to see how the body affects the study drug when it is given in single doses.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: GW642444 Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Single-Dose, Dose-Ascending, Double-Blind, Placebo-Controlled, 5-Way Crossover Study to Investigate the Efficacy, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M in Asthmatic Patients |
Enrollment: | 24 |
Study Start Date: | April 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
arm 2: Placebo Comparator |
Drug: Placebo
comparator
|
arm 1: Experimental |
Drug: GW642444
investigational drug or placebo
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A female subject is eligible to participate if she is of:
Predicted values are based on the ECCS 1993 normal ranges.
Exclusion Criteria:
Australia, Queensland | |
GSK Investigational Site | |
Auchenflower, Queensland, Australia, 4066 | |
Australia, Victoria | |
GSK Investigational Site | |
Clayton, Victoria, Australia, 3168 | |
New Zealand | |
GSK Investigational Site | |
Wellington 6004, New Zealand, 6004 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | B2C111401 |
Study First Received: | June 18, 2008 |
Last Updated: | June 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00702910 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Medicines and Medical Devices Safety Authority; New Zealand: Medsafe |
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Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
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Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |