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

March 6, 2014 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of asthma

Exclusion Criteria:

  • Habitual cigarette smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FEV1
Time Frame: Measured every 2 weeks
Measured every 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
PC20 methacholine
Time Frame: Measured every 2 weeks
Measured every 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

January 21, 2008

First Submitted That Met QC Criteria

January 21, 2008

First Posted (Estimate)

February 1, 2008

Study Record Updates

Last Update Posted (Estimate)

March 10, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL6788-15958-08
  • 5P50HL056385 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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