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

Completed · Not applicable

Conditions studied: Lung Disease

In brief

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.

Key facts

Study ID: NCT01184118
Run by: University of Wisconsin, Madison
People needed: 36
Starts: 2009-03-01
Expected to finish: 2011-02-01
Last updated by the study team: 2016-09-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

age 18-65;
history consistent with asthma
symptoms consistent with NAEPP26 asthma severity step ≥2 (in the past 2-4 weeks, presence of any of the following: daytime symptoms >2 days/week; or nighttime symptoms 3-4x/month; or short acting bronchodilator use (not for prevention of exercise induced asthma) >2 days/week, requiring addition on a controller therapy, using the NAEPP Asthma Step Categorization guidelines
FEV1≥65%
confirmation of asthma diagnosis by bronchodilator reversibility (≥12% improvement in FEV1 from baseline following 2 puffs of a β-2 agonist) or a provocative concentration of methacholine needed to produce a 20% fall in FEV1 (PC20) of ≤ 8 mg/ml.

You may not qualify if…

any use of inhaled corticosteroid for >2 weeks at a time during the last 6 months, or any use in the last 6 weeks
as needed use of nasal steroids in the prior 6 months (regular use is allowed without washout needed prior to testing visits)
use of medications listed in Table 1. Inhaled long acting β-adrenergics are permitted for entry and should be continued during this study
respiratory infection during the prior 4 weeks or asthma exacerbation during the prior 6 weeks to enrollment
presence of other lung diseases
evidence of significant medical (such as angina, heart failure, stroke) or psychiatric illnesses
diagnosed osteopenia (on treatment) or osteoporosis
established diagnosis of neuromuscular disease (e.g. multiple sclerosis, syringomyelia, transverse myelitis, amyotrophic lateral sclerosis (ALS), poliomyelitis, Lambert Eaton syndrome, Guillain-Barre syndrome, myasthenia gravis, myotonic dystrophy, mononeuritis multiplex, in the setting of polymyositis/dermatomyositis or severe cervical spine disease)
BMI greater than 35 kg/m2
currently on treatment for OSA
new diagnosis of OSA if OAI > 10/hour or desaturation <70% on dPSG (V2
pregnancy or desire to get pregnant in the upcoming 6 months (subjects of child-bearing potential must agree to use an acceptable method of birth control per ACRN guidelines, as stated in the consent form: i.e. if not post-menopausal [1 year or more since last menses] or surgically sterile [hysterectomy, tubal ligation, or vasectomy in monogamous partner], subject must use one of the following acceptable birth control methods: abstinence, birth control pills, diaphragm, intra-uterine device [IUD], Norplant, Depo-Provera, NuvaRing, birth control patches [e.g., Ortho Evra], single or double barrier methods [condom plus foam/jelly or condom plus diaphragm])
cigarettes > 1pack/month or cigars in the year before study or overall tobacco use greater than 10 pack years
inability to abstain from alcohol ingestion for 24 hours prior to sleep studies
any current use of benzodiazepins, opioids or barbiturates; 16) any current use of recreational drugs.

Where it is running

Univeristy of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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