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NCT00606242 Clinical Trial

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

Asthma Clinical Trial

— FluSAL  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00606242
Other study ID # HL6788-15958-08
Secondary ID 5P50HL056385
Status Completed
Phase Phase 4
First received January 21, 2008
Last updated March 6, 2014
Start date January 2000
Est. completion date December 2007

Study information
Verified date March 2014
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date December 2007
Est. primary completion date December 2002
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of asthma

Exclusion Criteria:

- Habitual cigarette smoking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Fluticasone
Inhaled Fluticasone, either 100 or 1000 mcg per day

Locations
Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (3)
Lead Sponsor Collaborator
University of California, San Francisco GlaxoSmithKline, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary FEV1 Measured every 2 weeks No
Secondary PC20 methacholine Measured every 2 weeks No
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