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

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT00606242
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), GlaxoSmithKline (Industry)
44
Enrollment
1
Location
2
Arms
95
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Jan 1, 2000
Actual Primary Completion Date :
Dec 1, 2002
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Low dose steroid

Fluticasone, 100 mcg per day

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

    		•
    Active Comparator: High dose steroid

    Fluticasone, 1000 mcg per day

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. FEV1 [Measured every 2 weeks]

    Secondary Outcome Measures

    1. PC20 methacholine [Measured every 2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Clinical diagnosis of asthma
    Exclusion Criteria:
    • Habitual cigarette smoking

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94143

    Sponsors and Collaborators

    • University of California, San Francisco
    • National Heart, Lung, and Blood Institute (NHLBI)
    • GlaxoSmithKline

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00606242
    Other Study ID Numbers:
    • HL6788-15958-08
    • 5P50HL056385
    First Posted:
    Feb 1, 2008
    Last Update Posted:
    Mar 10, 2014
    Last Verified:
    Mar 1, 2014
    Additional relevant MeSH terms:
    Asthma
    Fluticasone

    Study Results

    No Results Posted as of Mar 10, 2014