CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
FP 220 mcg 2 puffs BIDdrug
Likely dose
FP 220 mcg 2 puffs BIDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01184118
NCT01184118N/ACompleted
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Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea? DREAM-A Pilot Study

University of Wisconsin, Madison·interventional·Posted Aug 18, 2010·Updated Sep 7, 2016

In Brief

A clinical study evaluating FP 220 mcg 2 puffs BID for Lung Disease. Completed, enrolled 36 participants across 1 site.

Detailed Summary

This study is being conducted to find out if the use of inhaled corticosteroids has an affect on upper airway (UAW) collapsibility and sleep apnea risk. An inhaled corticosteroid is a common asthma controller medication like Flovent. Sleep apnea or sleep deprived breathing (SDB) is when someone stops breathing for a short period of time during sleep. For some reason, people with asthma have more sleep apnea and upper airway (UAW) collapsibility (weakness) than the general population. There are many possible reasons for this and one might be related to the use of inhaled corticosteroids. The overall hypothesis of this study is to determine whether inhaled fluticasone propionate (FP) increases UAW collapsibility and to assess tongue (genioglossus muscle) dysfunction as a potential underlying mechanism.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Disease
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), Brigham and Women's Hospital, University of California, San Diego, University of California, San Francisco, National Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 18, 2010
Enrollment StartMar 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.9 years ago

Interventions

FP 220 mcg 2 puffs BIDdrug

The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.