Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-saline in Asthma (FluSAL)

This study has been completed.
Information provided by:
University of California, San Francisco Identifier:
First received: January 21, 2008
Last updated: March 6, 2014
Last verified: March 2014

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.

Condition Intervention Phase
Drug: Fluticasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized Double Blind Study of the Dose Response Effects of Fluticasone Propionate on Hypertonic-saline Induced Bronchoconstriction in Asthmatic Subjects

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • FEV1 [ Time Frame: Measured every 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PC20 methacholine [ Time Frame: Measured every 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2000
Study Completion Date: December 2007
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low dose steroid
Fluticasone, 100 mcg per day
Drug: Fluticasone
Inhaled Fluticasone, either 100 or 1000 mcg per day
Other Name: Flovent
Active Comparator: High dose steroid
Fluticasone, 1000 mcg per day
Drug: Fluticasone
Inhaled Fluticasone, either 100 or 1000 mcg per day
Other Name: Flovent


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of asthma

Exclusion Criteria:

  • Habitual cigarette smoking
  Contacts and Locations
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Please refer to this study by its identifier: NCT00606242

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: John Fahy, University of California, San Francisco Identifier: NCT00606242     History of Changes
Other Study ID Numbers: HL6788-15958-08, 5P50HL056385
Study First Received: January 21, 2008
Last Updated: March 6, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on September 02, 2015