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

Lung Disease Clinical Trial

— DREAM  

Official title:

Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea? DREAM-A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184118
• Other study ID #: H-2008-0265
• Status: Completed
• Phase: N/A
• First received: August 17, 2010
• Last updated: April 28, 2011
• Start date: March 2009
• Est. completion date: February 2011

Study information

• Verified date: April 2011
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board (UW Madison)United States: Food and Drug AdministrationUnited States: National Institutes of Health
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ß-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 ß-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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Univeristy of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (5)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Brigham and Women's Hospital, National Institutes of Health (NIH), University of California, San Diego, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure for this study is critical closing pressure (Pcrit) change from baseline with 16-week of high dose inhaled FP treatment.	UAW collapsibility, as measured by critical closing pressure (Pcrit), defined as the maximum nasal pressure at which the UAW occludes.	End of study 3/2011	No
Secondary	Severity of obstructive SDB, sleep quality and quality of life related to sleep apnea assessed on validated questionnaires (SA-SDQ, ESS, PSQI, and SAQLI	Secondary goals include evaluating effects of this medication on severity of obstructive SDB (validated SA-SDQ)	End of study 3/2011	No
Secondary	Tongue strength and fatigability (assessed using the Iowa Oral Performance Instrument	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.	End of study 03/2011	No