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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00812773 |
This study will evaluate the safety and effect of repeat oral doses of GSK2190915 on lung function in mild asthmatics using a number of clinical and biological markers of efficacy.
Condition | Intervention | Phase |
---|---|---|
Mild Asthma |
Drug: GSK2190915 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled, 3-Period Cross-Over Study to Evaluate the Effect of Two Doses of GSK2190915 on the Allergen-Induced Early Asthmatic Response in Subjects With Mild Asthma |
Estimated Enrollment: | 18 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
3 day repeat dose: Experimental |
Drug: GSK2190915
Investigational Product
|
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
[number of pack years = (number of cigarettes per day/20) x number of years smoked]
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United Kingdom | |
GSK Investigational Site | Recruiting |
London, United Kingdom, NW10 7NS | |
GSK Investigational Site | Active, not recruiting |
Manchester, United Kingdom, M23 9QZ | |
GSK Investigational Site | Recruiting |
London, United Kingdom, W1G 8HU |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 112356 |
Study First Received: | December 8, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00812773 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
GSK2190915 Asthma Oral Allergen |
Challenge Repeat Dose |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases |