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

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)

Inclusion criteria

• 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.

Exclusion criteria

• 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.