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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00748306 |
The purpose of this study is to determine the safety and usefulness of GSK2190915 in asthmatic patients who develop asthma symptoms following being challenged.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Placebo Drug: GSK2190915 - 100mcg |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled, 2-Period Cross-Over Study to Evaluate the Effect of Treatment With GSK2190915 on the Allergen-Induced Asthmatic Response in Subjects With Mild Asthma |
Estimated Enrollment: | 24 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
GSK2190915: Experimental
Intervention
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Drug: GSK2190915 - 100mcg
GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor
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Placebo: Placebo Comparator |
Drug: Placebo
Matching Intervention Drug
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Netherlands | |
GSK Investigational Site | Recruiting |
LEIDEN, Netherlands, 2333 CL | |
United Kingdom | |
GSK Investigational Site | Withdrawn |
London, United Kingdom, SE5 9RJ | |
GSK Investigational Site | Withdrawn |
London, United Kingdom, W1G 8HU | |
GSK Investigational Site | Recruiting |
London, United Kingdom, W1G 8HU | |
GSK Investigational Site | Recruiting |
London, United Kingdom, NW10 7EW | |
United Kingdom, Lancashire | |
GSK Investigational Site | Recruiting |
Manchester, Lancashire, United Kingdom, M23 9LT |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111834, 915 Phase IIa |
Study First Received: | September 5, 2008 |
Last Updated: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00748306 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Allergen challenge methacholine mild asthmatics early asthmatic response |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases Lung Diseases |
Methacholine Chloride Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |