Positive Airway Pressure for the Treatment of Asthma

NCT01154699 | Completed Results

• 3 other identifiers: 2009-P-001733/11F32HL097578-015K23HL105542
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is an extremely common disorder, which is becoming more prevalent. The purpose of this study is to examine how nocturnal lung volumes contribute to asthma severity, which may explain part of the link between asthma and obesity. The investigators seek to test the hypothesis that raising lung volumes during the night will improve asthma symptoms. The investigators work may lead to new targets for therapy.

Conditions

Asthma; Sleep Apnea

Keywords

Asthma; Nocturnal Asthma; Lung volumes; Deep inspiration; Obstructive sleep apnea

Outcome Measures

Primary Outcomes (2)

• Asthma Control Test

  Well validated questionnaire of asthma symptoms which includes 5 written questions. Each question is answered on a scale of 1-5, which are summed to report a range of asthma control from 5 to 25 (higher score indicates better asthma control).

  Every 4 weeks during the 12 week study (at the start and end of the Usual Care period, and at the start and end of the Bilevel PAP intervention period)

• Airway Reactivity as Measured by Methacholine Challenge (PC20)

  This is a physiological measurement derived from repeated breathing maneuvers which measures airway reactivity. Subjects are exposed to higher and higher concentrations of an airway irritant (in this case methacholine), and between each dose perform spirometry. The test is stopped after the forced expiratory volume in 1 second (FEV1) falls 20% below the baseline. The concentration of methacholine at which this occurs is called the PC20. Methacholine challenges are routinely used in the diagnosis of asthma, and in many asthma research studies to measure changes in airway reactivity.

  Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)

Secondary Outcomes (4)

• Epworth Sleepiness Scale (ESS)

  Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)

• Pittsburgh Sleep Quality Index (PSQI)

  Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)

• Short Form (SF-36) Health Survey

  Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)

• FEV1 %Predicted

  Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)

Study Arms (2)

Usual Care first, then Bilevel PAP

EXPERIMENTAL

Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period. After a "Washout Period" of an additional 4 weeks of usual care, they will then start Bilevel PAP therapy for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests.

Device: Bilevel PAP (4 weeks); Other: Usual Care (4 weeks); Other: Washout Period (4 weeks)

Bilevel PAP first, then Usual Care

EXPERIMENTAL

Subjects will begin the study by starting on Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests. After a 4 week "Washout Period" of usual care, they will start a Usual Care period for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period.

Device: Bilevel PAP (4 weeks); Other: Usual Care (4 weeks); Other: Washout Period (4 weeks)

Interventions

Bilevel PAP (4 weeks) DEVICE

Subjects will use bilevel PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night.

Also known as: Bilevel positive airway pressure

Bilevel PAP first, then Usual Care; Usual Care first, then Bilevel PAP

Usual Care (4 weeks) OTHER

Subjects will continue with their usual asthma care. Investigators will make no changes to their medications or other habits.

Bilevel PAP first, then Usual Care; Usual Care first, then Bilevel PAP

Washout Period (4 weeks) OTHER

Subjects will continue with their usual asthma care in between the Usual Care and Bilevel PAP periods. Investigators will make no changes to their medications or other habits.

Bilevel PAP first, then Usual Care; Usual Care first, then Bilevel PAP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild to moderate asthma, diagnosed by a physician, OR
• mild to moderate asthma and CPAP treated OSA. Must be compliant with CPAP therapy (greater than 4 hours per night, at least 4 nights/week)

You may not qualify if:

• lung disease other than asthma or OSA
• medications known to affect respiratory function (apart from asthma and rhinitis therapy)
• abnormal nasal anatomy
• current smokers and ex-smokers (quit within the last 3 months, or \>10 pack-years)
• pregnant women - women of child bearing age will undergo a urine pregnancy test before enrollment and during the course of the study, as some of the study procedures cannot be performed during pregnancy and because pregnancy often changes asthma symptoms and severity.
• severe asthma - defined as a recent exacerbation (doctor or ER visit for asthma, or oral steroid use, within the previous 4 weeks) or frequent exacerbations (\>4 exacerbations in the last year.
• severe obstructive sleep apnea requiring supplemental oxygen in addition to CPAP therapy.
• the regular use of prescription (e.g. zolpidem) or over-the-counter sleep aids (e.g. Benadryl).
• Central sleep apnea

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Asthma; Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Robert L. Owens
• Organization: University of California San Diego

rowens@ucsd.edu

8586575258

Study Officials

• Robert L Owens, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: July 1, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 17, 2017
• Results First Posted: May 17, 2017

Record last verified: 2017-05

Locations

US (1)