Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00766090
First received: October 2, 2008
Last updated: February 5, 2010
Last verified: February 2010
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Purpose
The purpose of this study is to compare once and twice daily GW685698 in asthma
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: GW685698X |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-Centre, Randomized, Double Blind Cross-over Study to Assess the Non-inferiority of GW685698X 200mcg Once Daily and 100mcg Twice Daily in Adult and Adolescent Patients With Asthma |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- safety and efficacy [ Time Frame: study duration ] [ Designated as safety issue: No ]
| Enrollment: | 190 |
| Study Start Date: | October 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: GW685698X |
Drug: GW685698X
Inhaled Corticosteroid
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Clinical diagnosis of Asthma
- Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol
- FEV1 between 40-85% predicted
- Currently on short acting beta2 agonist therapy
Key Exclusion Criteria:
- History of life threatening asthma
- Respiratory Infection or oropharyngeal candidiasis
- Asthma exacerbation
- Uncontrolled disease or clinical abnormality
- Allergies
- Taking another Investigational medications or other prohibited medications
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00766090
Locations
| United States, California | |
| GSK Investigational Site | |
| Long Beach, California, United States, 90806 | |
| GSK Investigational Site | |
| Long Beach, California, United States, 90808 | |
| GSK Investigational Site | |
| Torrance, California, United States, 90505 | |
| United States, Florida | |
| GSK Investigational Site | |
| Cocoa, Florida, United States, 32927 | |
| GSK Investigational Site | |
| Tallahassee, Florida, United States, 32308 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Bethesda, Maryland, United States, 20814 | |
| United States, Missouri | |
| GSK Investigational Site | |
| Columbia, Missouri, United States, 65203 | |
| GSK Investigational Site | |
| Rolla, Missouri, United States, 65401 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Canton, Ohio, United States, 44718 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Medford, Oregon, United States, 97504 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Orangeburg, South Carolina, United States, 29118 | |
| United States, Texas | |
| GSK Investigational Site | |
| Austin, Texas, United States, 78750 | |
| GSK Investigational Site | |
| Boerne, Texas, United States, 78006 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| GSK Investigational Site | |
| Waco, Texas, United States, 76712 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00766090 History of Changes |
| Other Study ID Numbers: | 112202 |
| Study First Received: | October 2, 2008 |
| Last Updated: | February 5, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013