Positive Airway Pressure for the Treatment of Asthma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert L. Owens, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01154699
First received: June 18, 2010
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Sleep Apnea
Device: Bi-level positive airway pressure (bi-level PAP)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Positive Airway Pressure for the Treatment of Asthma

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: After 4 weeks of intervention ] [ Designated as safety issue: No ]
    The Asthma Quality of Life Questionnaire (AQLQ) consists of 32 questions answered by subjects focused on asthma symptoms and ability to carry on activities of daily living. It is well validated, and frequently used in large clinical asthma studies as a primary endpoint. Changes of +/- 0.5 on this scale are considered clinically relevant.


Secondary Outcome Measures:
  • Airway reactivity as measured by Methacholine Challenge. [ Time Frame: After 4 weeks of intervention ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Baseline
Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
Experimental: Bi-level PAP
Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.
Device: Bi-level positive airway pressure (bi-level PAP)
Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night.

Detailed Description:

Asthma is a chronic respiratory disease characterized by airway inflammation and airway hyperresponsiveness, which causes airflow obstruction. It is extremely prevalent, affecting an estimated 22 million Americans, and costly with loss of productivity and direct healthcare costs in the billions of dollars. The incidence and prevalence of asthma are increasing, both in the US and around the world. This increase comes despite greater understanding of the inflammatory and allergic basis for asthma, and despite better antiinflammatory medications. One explanation for the increasing prevalence of asthma is the concomitant increase in obesity, with the majority of Americans now overweight or obese. Numerous studies have convincingly linked asthma and obesity, and demonstrated increased obstruction with weight gain and decreased obstruction with weight loss. However, the mechanisms that underlie this linkage are not known.

We believe that low lung volumes contribute to the pathogenesis and severity of asthma. End-expiratory lung volume is decreased in obesity, and likely falls further during sleep, particularly in overweight and obese patients. Both upper and lower airway resistance increase with decreasing lung volumes, as airways become smaller. However, prior work has shown that lower airway resistance increases out of proportion to the decrease in lung volume that occurs during sleep in asthma patients. This difference between controls and people with asthma has not been further explored, yet may provide insight into asthma pathogenesis and provide potential targets for therapy.

Therefore, we propose a series of experiments to define the impact of lung volumes during sleep on airway resistance. One of these experiments will be to to test the hypothesis that lung stretch can be used therapeutically by tonically and dynamically increasing lung volumes during sleep using bi-level positive airway pressure. This research can help delineate asthma pathogenesis and may help improve therapeutic options in this exceedingly common disease.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  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: NCT01154699

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Robert L Owens, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Robert L. Owens, Instructor in Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01154699     History of Changes
Other Study ID Numbers: 2009-P-001733/1, 1F32HL097578-01, 5K23HL105542
Study First Received: June 18, 2010
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Asthma
Nocturnal Asthma
Lung volumes
Deep inspiration
Obstructive sleep apnea

Additional relevant MeSH terms:
Asthma
Sleep Apnea Syndromes
Apnea
Bronchial Diseases
Dyssomnias
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Nervous System Diseases
Respiration Disorders
Respiratory Hypersensitivity
Respiratory Tract Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 21, 2014