Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-Saline in Asthma - Full Text View

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

This study has been completed.

First Received on January 21, 2008. No Changes Posted

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Collaborator:	GlaxoSmithKline
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00606242

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 IV

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

Drug Information available for: Fluticasone propionate Fluticasone

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 February 09, 2012