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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluticasone
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of asthma

Exclusion Criteria:

  • Habitual cigarette smoking

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low dose steroid

High dose steroid

Arm Description

Fluticasone, 100 mcg per day

Fluticasone, 1000 mcg per day

Outcomes

Primary Outcome Measures

FEV1

Secondary Outcome Measures

PC20 methacholine

Full Information

First Posted
January 21, 2008
Last Updated
March 6, 2014
Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00606242
Brief Title
Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-saline in Asthma
Acronym
FluSAL
Official Title
A Randomized Double Blind Study of the Dose Response Effects of Fluticasone Propionate on Hypertonic-saline Induced Bronchoconstriction in Asthmatic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose steroid
Arm Type
Active Comparator
Arm Description
Fluticasone, 100 mcg per day
Arm Title
High dose steroid
Arm Type
Active Comparator
Arm Description
Fluticasone, 1000 mcg per day
Intervention Type
Drug
Intervention Name(s)
Fluticasone
Other Intervention Name(s)
Flovent
Intervention Description
Inhaled Fluticasone, either 100 or 1000 mcg per day
Primary Outcome Measure Information:
Title
FEV1
Time Frame
Measured every 2 weeks
Secondary Outcome Measure Information:
Title
PC20 methacholine
Time Frame
Measured every 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of asthma Exclusion Criteria: Habitual cigarette smoking
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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