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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00945932 |
Purpose
This study will measure the effect of repeat inhaled doses of GW870086X on lung function.
| Condition | Intervention | Phase |
|---|---|---|
|
Mild Asthma Moderate Asthma |
Drug: GW870086X Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-blind, Placebo-controlled, 2-way Crossover Study to Determine the Efficacy of Repeat Inhaled Doses of GW870086X on FEV1 in Mild to Moderate Asthmatics |
| Enrollment: | 37 |
| Study Start Date: | July 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 28 day repeat dose |
Drug: GW870086X
Investigational product
Drug: Placebo
Placebo control
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| GSK Investigational Site | |
| Ruedersdorf, Brandenburg, Germany, 15562 | |
| GSK Investigational Site | |
| Frankfurt, Hessen, Germany, 60596 | |
| GSK Investigational Site | |
| Mainz, Rheinland-Pfalz, Germany, 55131 | |
| GSK Investigational Site | |
| Geesthacht, Schleswig-Holstein, Germany, 21502 | |
| GSK Investigational Site | |
| Berlin, Germany, 14057 | |
| GSK Investigational Site | |
| Berlin, Germany, 10787 | |
| GSK Investigational Site | |
| Berlin, Germany, 10717 | |
| GSK Investigational Site | |
| Berlin, Germany, 10367 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00945932 History of Changes |
| Other Study ID Numbers: | 112851 |
| Study First Received: | July 16, 2009 |
| Last Updated: | February 18, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
GW870086X Efficacy FEV1 asthma repeat-dose |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |