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

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
University of California, San Diego
University of California, San Francisco
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01184118
First received: August 17, 2010
Last updated: April 28, 2011
Last verified: April 2011
  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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)
Intervention Details:
    Drug: fluticasone propionate
    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.
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 18-65;
  2. history consistent with asthma
  3. 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
  4. FEV1≥65%
  5. 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:

  1. any use of inhaled corticosteroid for >2 weeks at a time during the last 6 months, or any use in the last 6 weeks
  2. as needed use of nasal steroids in the prior 6 months (regular use is allowed without washout needed prior to testing visits)
  3. use of medications listed in Table 1. Inhaled long acting β-adrenergics are permitted for entry and should be continued during this study
  4. respiratory infection during the prior 4 weeks or asthma exacerbation during the prior 6 weeks to enrollment
  5. presence of other lung diseases
  6. evidence of significant medical (such as angina, heart failure, stroke) or psychiatric illnesses
  7. diagnosed osteopenia (on treatment) or osteoporosis
  8. 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)
  9. BMI greater than 35 kg/m2
  10. currently on treatment for OSA
  11. new diagnosis of OSA if OAI > 10/hour or desaturation <70% on dPSG (V2
  12. 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])
  13. cigarettes > 1pack/month or cigars in the year before study or overall tobacco use greater than 10 pack years
  14. inability to abstain from alcohol ingestion for 24 hours prior to sleep studies
  15. any current use of benzodiazepins, opioids or barbiturates; 16) any current use of recreational drugs.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184118

Locations
United States, Wisconsin
Univeristy of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Brigham and Women's Hospital
University of California, San Diego
University of California, San Francisco
Investigators
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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 28, 2014