Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-saline in Asthma
Overview
This study investigates the effect of a inhaled corticosteroid (fluticasone or "Flovent") on airway narrowing induced by hypertonic saline (salty water). The study hypothesis is that fluticasone will be more effective in preventing saline-induced airway narrowing than methacholine-induced narrowing.
Full Title of Study: “A Randomized Double Blind Study of the Dose Response Effects of Fluticasone Propionate on Hypertonic-saline Induced Bronchoconstriction in Asthmatic Subjects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Basic Science
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: December 2002
Interventions
- Drug: Fluticasone
- Inhaled Fluticasone, either 100 or 1000 mcg per day
Arms, Groups and Cohorts
- Active Comparator: Low dose steroid
- Fluticasone, 100 mcg per day
- Active Comparator: High dose steroid
- Fluticasone, 1000 mcg per day
Clinical Trial Outcome Measures
Primary Measures
- FEV1
- Time Frame: Measured every 2 weeks
Secondary Measures
- PC20 methacholine
- Time Frame: Measured every 2 weeks
Participating in This Clinical Trial
Inclusion Criteria
- Clinical diagnosis of asthma Exclusion Criteria:
- Habitual cigarette smoking
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- University of California, San Francisco
- Collaborator
- National Heart, Lung, and Blood Institute (NHLBI)
- Provider of Information About this Clinical Study
- John Fahy, University of California, San Francisco
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