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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00368576 |
The purpose of this study is to compare the effects of SB-480848 with placebo in subjects with asthma.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: SB 480848, tablets |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double-Blind, Parallel Assignment, Safety Study |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Repeat Dose Study to Assess the Effect of SB-480848 on Overall Asthma Control in Adult Subjects With Persistent Asthma Controlled on Stable, Low-Dose, Inhaled Corticosteroids |
Enrollment: | 67 |
Study Start Date: | August 2006 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
During the run-in period [Day -14 to Day 1], subjects will be asked to maintain a diary card and document the number of puffs of rescue inhaled, short-acting β2-agonists taken, asthma-related symptoms and night time awakenings as well as morning and evening PEF measurements.
On the morning of Day 0, subjects will be eligible for randomisation into the study if all of the following criteria are met:
Exclusion criteria:
United States, California | |
GSK Investigational Site | |
Cypress, California, United States, 90630 | |
United States, Illinois | |
GSK Investigational Site | |
Normal, Illinois, United States, 61761 | |
United States, Massachusetts | |
GSK Investigational Site | |
North Dartmouth, Massachusetts, United States, 02747 | |
United States, South Carolina | |
GSK Investigational Site | |
Spartanburg, South Carolina, United States, 29303 | |
Germany | |
GSK Investigational Site | |
Berlin, Germany, 14050 | |
Germany, Bayern | |
GSK Investigational Site | |
Neu-Ulm, Bayern, Germany, 89231 | |
Germany, Schleswig-Holstein | |
GSK Investigational Site | |
Grosshansdorf, Schleswig-Holstein, Germany, 22927 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | LPL107629 |
Study First Received: | August 22, 2006 |
Last Updated: | May 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00368576 History of Changes |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices |
asthma inhaled steroid methacholine challenge SB-480848 |
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Methacholine Chloride Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
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Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |