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Corticosteroid
Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-saline in Asthma (FluSAL Trial)
Phase 4
Waitlist Available
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Clinical diagnosis of asthma
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
All Individual Drugs Already Approved
Pivotal Trial
No Placebo-Only Group
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.
Eligible Conditions
- Asthma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Low dose steroidActive Control1 Intervention
Fluticasone, 100 mcg per day
Group II: High dose steroidActive Control1 Intervention
Fluticasone, 1000 mcg per day
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,788 Total Patients Enrolled
282 Trials studying Asthma
114,379 Patients Enrolled for Asthma
GlaxoSmithKlineIndustry Sponsor
4,815 Previous Clinical Trials
8,384,146 Total Patients Enrolled
302 Trials studying Asthma
500,460 Patients Enrolled for Asthma
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,906 Total Patients Enrolled
34 Trials studying Asthma
20,310 Patients Enrolled for Asthma