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

NCT01184118 | Completed Results DMC

• 2 other identifiers: H-2008-0265U10HL074212
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Disease

Keywords

asthma; sleep apnea

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Improved, Unchanged, and Worsened Critical Closing Pressure (Pcrit) From Baseline With 16-week of High Dose Inhaled FP Treatment.

  Upper airway (UAW) collapsibility, as measured by critical closing pressure (Pcrit), defined as the maximum nasal pressure at which the UAW occludes. Subjects were divided into 3 subgroups: improved (more negative Pcrit), unchanged, or worsened (less negative Pcrit).

  16 weeks

Secondary Outcomes (2)

• Number of Participants With Improved, Unchanged, and Worsened Sleep Disorders Questionnaire (SA-SDQ) From Baseline With 16-week of High Dose Inhaled FP Treatment.

  16 weeks

• Number of Participants With Improved, Unchanged, and Worsened Anterior Tongue Strength (KPa) From Baseline With 16-week of High Dose Inhaled FP Treatment.

  16 weeks

Study Arms (2)

FP Discontinued

NO INTERVENTION

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.

FP 220 mcg 2 puffs BID

ACTIVE COMPARATOR

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.

Drug: FP 220 mcg 2 puffs BID

Interventions

FP 220 mcg 2 puffs BID 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.

Also known as: Fluticasone propriante

FP 220 mcg 2 puffs BID

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• Brigham and Women's Hospital: collaborator
• University of California, San Diego: collaborator
• University of California, San Francisco: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Univeristy of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Lung Diseases; Asthma; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

We were unsuccessful at securing placebo MDI, and the lack of a control group raises the possibility that our findings may reflect natural history of pharyngeal upper airway patency in asthma.

Results Point of Contact

• Title: Mihaela Teodorescu, MD
• Organization: UW Madison

mt3@medicine.wisc.edu

608-256-1901

Study Officials

• Mihaela Teodorescu, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 18, 2010
• Study Start: March 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: September 7, 2016
• Results First Posted: June 13, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)