NCT01184118

DREAM: Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea Manifestations?

Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea? DREAM-A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To address this hypothesis, we specifically aim is to determine the effects of 16 weeks of treatment with inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 880 mcg twice daily, on: Specific Aim 1: UAW collapsibility, as measured by Pcrit during NREM sleep; Specific Aim 2: Severity of obstructive SDB and sleep quality, and quality of life related to sleep apnea assessed on validated questionnaires (Sleep Apnea scale of the Sleep Disorders Questionnaire \[SA-SDQ\], Epworth Sleepiness Scale \[ESS\]) and Pittsburgh Sleep Quality Index \[PSQI\], and Sleep Apnea Quality of Life Index \[SAQLI\]); Specific Aim 3: Tongue strength and fatigability (assessed using the Iowa Oral Performance Instrument)

Conditions

• Lung Disease

Interventions

Type	Name	Description
DRUG	FP 220 mcg 2 puffs BID	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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-08-18
• Last updated: 2016-09-07
• Results posted: 2016-06-13

Locations

1 site across 1 country: United States