DREAM: Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea Manifestations?
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Purpose
This study is being conducted to find out if the use of inhaled corticosteroids has an affect on upper airway collapsibility and sleep apnea risk. An inhaled corticosteroid is a common asthma controller medication like Flovent. Sleep apnea is w hen someone stops breathing for a short period of time during sleep. For some reason, people with asthma have more sleep apnea and upper airway 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.
| Condition | Intervention |
|---|---|
|
Lung Disease |
Drug: fluticasone propionate |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea? DREAM-A Pilot Study |
- The primary outcome measure for this study is critical closing pressure (Pcrit) change from baseline with 16-week of high dose inhaled FP treatment. [ Time Frame: End of study 3/2011 ] [ Designated as safety issue: No ]UAW collapsibility, as measured by critical closing pressure (Pcrit), defined as the maximum nasal pressure at which the UAW occludes.
- Severity of obstructive SDB, sleep quality and quality of life related to sleep apnea assessed on validated questionnaires (SA-SDQ, ESS, PSQI, and SAQLI [ Time Frame: End of study 3/2011 ] [ Designated as safety issue: No ]Secondary goals include evaluating effects of this medication on severity of obstructive SDB (validated SA-SDQ)
- Tongue strength and fatigability (assessed using the Iowa Oral Performance Instrument [ Time Frame: End of study 03/2011 ] [ Designated as safety issue: No ]The Iowa Oral Performance Instrument (IOPI) will be used. This instrument has a standard-sized air-filled polymer balloon, called tongue sensor or bulb, which can be inserted between the tongue blade and the roof of the mouth.
| Estimated Enrollment: | 36 |
| Study Start Date: | March 2009 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
-
Drug: fluticasone propionate
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)
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Wisconsin | |
| Univeristy of Wisconsin Hospital and Clinics | |
| Madison, Wisconsin, United States, 53792 | |
| Principal Investigator: | Mihaela Teodorescu, MD | University of Wisconsin, Madison |
More Information
No publications provided
| Responsible Party: | Mihaela Teodorscu, MD, University of Wisconsin Madison |
| ClinicalTrials.gov Identifier: | NCT01184118 History of Changes |
| Other Study ID Numbers: | H-2008-0265 |
| Study First Received: | August 17, 2010 |
| Last Updated: | April 28, 2011 |
| Health Authority: | United States: Institutional Review Board (UW Madison) United States: Food and Drug Administration United States: National Institutes of Health |
Keywords provided by University of Wisconsin, Madison:
|
asthma sleep apnea |
Additional relevant MeSH terms:
|
Apnea Lung Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
Fluticasone Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013