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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