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.

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) 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

MedlinePlus related topics:

Asthma

Drug Information available for:

Sodium chloride Fluticasone Fluticasone propionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study

Official Title:	A Randomized Double Blind Study of the Dose Response Effects of Fluticasone Propionate on Hypertonic-Saline Induced Bronchoconstriction in Asthmatic Subjects

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
Low dose steroid: Active Comparator Fluticasone, 100 mcg per day	Drug: Fluticasone Inhaled Fluticasone, either 100 or 1000 mcg per day
High dose steroid: Active Comparator Fluticasone, 1000 mcg per day	Drug: Fluticasone Inhaled Fluticasone, either 100 or 1000 mcg per day

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

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

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Fluticasone

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Bronchial Diseases

Immune System Diseases

Physiological Effects of Drugs

Anti-Asthmatic Agents

Anti-Allergic Agents

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on November 06, 2008