This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain clinic visits will include a physical examination, lung function tests, inflammatory cell analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA approved virus through their nose which is known to cause the common cold. All study related medications and medical...
Date First Received: July 17, 2007
Last Updated: October 27, 2008
Verified by: GlaxoSmithKline, October 2008
Clinical Trial Phase: Phase 4 | Start Date: October 2007
Overall Status: Completed
Estimated Enrollment: 45
Brief Summary
Official Title: “An Exploratory Study to Evaluate the Response of Salmeterol Plus Fluticasone Propionate vs Fluticasone Propionate Alone to Experimental Nasal Inoculation With Rhinovirus”
Condition Keyword(s):
Intervention(s):
This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain clinic visits will include a physical examination, lung function tests, inflammatory cell analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA approved virus through their nose which is known to cause the common cold. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: July 2008
Intervention(s) in this Clinical Trial
- Drug: fluticasone propionate/salmeterol, fluticasone propionate
Outcome Measures for this Clinical Trial
Primary Measures
- Lower respiratory symptom score
Secondary Measures
- Morning Peak Expiratory Flow Morning Forced Expiratory Volume in 1 second Exhaled Nitric Oxide
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Have asthma for at least 3 months prior to the study.
- Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
- Demonstrate airway hyperresponsiveness following inhalation of bronchoconstrictor.
- Have a positive allergic status antibody test.
Exclusion Criteria:
- Have a history of life-threatening asthma.
- Been hospitalized for asthma within the 24 months prior to the study.
- Have certain conditions that would make study participation unsafe.
- The study doctor will evaluate other inclusion and exclusion criteria.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 40 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on January 08, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00503009
Study ID Number: HZA109895
ClinicalTrials.gov Identifier: NCT00503009
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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