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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00606242
First received: January 21, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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
Asthma
 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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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

  Eligibility

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

Inclusion Criteria:

  • Clinical diagnosis of asthma

Exclusion Criteria:

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

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline
  More Information

No publications provided

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013