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

NCT ID: NCT01184118

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-02-28

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 controller medication like Flovent. Sleep apnea or sleep deprived breathing (SDB) is when someone stops breathing for a short period of time during sleep. For some reason, people with asthma have more sleep apnea and upper airway (UAW) 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.

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)

Conditions

Lung Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FP Discontinued

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

FP 220 mcg 2 puffs BID

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.

Group Type: ACTIVE_COMPARATOR

FP 220 mcg 2 puffs BID

Intervention Type: DRUG

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.

Interventions

FP 220 mcg 2 puffs BID

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.

Intervention Type: DRUG

Other Intervention Names

Fluticasone propriante

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mihaela Teodorescu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Univeristy of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

U10HL074212

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-2008-0265

Identifier Type: -

Identifier Source: org_study_id