Status:
COMPLETED
DREAM: Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea Manifestations?
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Institutes of Health (NIH)
Brigham and Women's Hospital
Conditions:
Lung Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 co...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01184118
Start Date
March 1 2009
End Date
February 1 2011
Last Update
September 7 2016
Active Locations (1)
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1
Univeristy of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792