Effect of Positive Airway Pressure on Reducing Airway Reactivity in Patients With Asthma (CPAP)
CPAP
2 other identifiers
interventional
209
1 country
18
Brief Summary
The CPAP trial is a 3-arm parallel design randomized sham-controlled trial. Participants are randomly assigned in equal allocation to one of three treatments: CPAP 10 cm water (H₂O) (high) vs. CPAP 5 cm H₂O (medium) vs. CPAP Sham (less than 1 cm H₂O, Low). The treatment period is 12 weeks with airways reactivity assessed at baseline, 6 and 12 weeks of treatment and after a 2 week washout.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Jul 2012
Typical duration for not_applicable asthma
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2012
CompletedFirst Posted
Study publicly available on registry
June 28, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
May 15, 2017
CompletedMay 15, 2017
April 1, 2017
2.3 years
June 25, 2012
January 30, 2017
April 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Methacholine Reactivity
The primary outcome measure was the change in provocative concentration of methacholine causing a 20% fall in forced expiratory volume in 1 second (FEV₁) (PC20) from baseline to 12 weeks. Modified American Thoracic Society guidelines were followed for pre-bronchodilator spirometry and methacholine challenge testing using the 5 breath dosimeter technique. Up to eleven doses, each a doubling concentration of methacholine (Provocholine™), were inhaled starting at 0.03 mg/mL until a 20% or greater fall in FEV₁ occurred; the maximum dose was 32 mg/mL. Breaths each of doubling concentrations of methacholine were inhaled from a calibrated DeVilbiss™ 646 nebulizer.
12 weeks after randomization
Study Arms (3)
CPAP less than 1 cm H₂O
SHAM COMPARATORCPAP 10cm H₂O
EXPERIMENTALCPAP 5cm H₂O
EXPERIMENTALInterventions
Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
Eligibility Criteria
You may qualify if:
- years of age at V1
- Physician diagnosis of asthma and on prescribed asthma medication for at least the past 12 months at V1
- Pre-bronchodilator FEV₁ greater than or equal to 75% predicted at V1 (to minimize the likelihood that variability in FEV₁ will preclude participants from having methacholine challenges in follow-up visits)
- Airways reactivity: Methacholine bronchial challenge with concentration of methacholine causing a 20% fall in forced expiratory volume in 1 second (PC ₂₀) less than or equal to 8 mg/mL at V1
- Stable asthma defined by no change in treatment, emergency department (ED) visit, hospitalization, or urgent health care visit for asthma for the 8 weeks prior to screening
- Non-smoker for more than 6 months and less than or equal to 10 pack-year history of smoking
- Ability and willingness to provide informed consent
- If receiving immunotherapy, must have had stable therapy for the 8 weeks prior to screening
- Spend a minimum of six hours per night in bed on average
- Willingness to sleep 5 days a week on average in the same place for the next 4 months
- For women of child bearing potential; not pregnant, not lactating and agree to practice and adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study
You may not qualify if:
- Weight less than or equal to 66 lbs. (30kg) at V1
- BMI greater than or equal to 35 at V1
- Acute respiratory illness in the month prior to screening
- Systemic corticosteroid therapy during the 3 months preceding screening
- History of sleep apnea by self-report High risk of sleep apnea as assessed by Multivariable Apnea Prediction (MAP) Index; high risk defined as probability that is equal to or greater than 20%
- Chronic diseases (other than asthma) that in the opinion of the investigator would interfere with participation in the trial or put the participant at risk by participation, e.g. non-skin cancer, chronic diseases of the lung (other than asthma), chronic heart diseases, endocrine diseases, liver, kidney or nervous system diseases, or immunodeficiency, any pre-existing conditions that may be contraindications to positive airway pressure including: severe bullous lung disease, pneumothorax, pathologically low blood pressure, dehydration, cerebrospinal fluid leak, recent cranial surgery, trauma, bypassed upper (supraglottic) airway
- Known sleep disorders that are currently under treatment by a sleep specialist
- Known intolerance to methacholine
- Absolute contraindications to methacholine that include: current use of beta-adrenergic blocking agent, heart attack or stroke in the last 3 months, uncontrolled hypertension, known aortic aneurysm
- Use of investigative drugs or intervention trials in the 30 days prior to screening or during the duration of the study
- Prior use of CPAP for any reason Homelessness, lack of telephone access, or intention to move within the next 4 months of the trial.
- For blinding purposes, members from the same household cannot participate in the study at the same time.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
University of Arizona
Tucson, Arizona, United States
University of California, San Diego
San Diego, California, United States
National Jewish Health
Denver, Colorado, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
University of Miami/ University of South Florida
Miami, Florida, United States
Illinois Consortium
Chicago, Illinois, United States
St. Vincent Hospital and Health Care Center, Inc
Indianapolis, Indiana, 46260, United States
Louisiana State University Health Sciences Center, The Ernest N. Morial Asthma, Allergy and Respiratory Disease Center
New Orleans, Louisiana, United States
University of Missouri, Kansas City School of Medicine
Kansas City, Missouri, United States
Washington University/ St. Louis University
St Louis, Missouri, United States
Hofstra University School of Medicine
Hempstead, New York, United States
Columbia University - New York University Consortium
New York, New York, United States
New York Medical College
Valhalla, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University Medical Center/ Columbus Children's Hospital
Columbus, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
Northern New England Consortium
Colchester, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Related Publications (1)
Holbrook JT, Sugar EA, Brown RH, Drye LT, Irvin CG, Schwartz AR, Tepper RS, Wise RA, Yasin RZ, Busk MF; American Lung Association Airways Clinical Research Centers. Effect of Continuous Positive Airway Pressure on Airway Reactivity in Asthma. A Randomized, Sham-controlled Clinical Trial. Ann Am Thorac Soc. 2016 Nov;13(11):1940-1950. doi: 10.1513/AnnalsATS.201601-043OC.
PMID: 27398992DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Janet T Holbrook, PhD, MPH
- Organization
- ALA-ACRC
Study Officials
- PRINCIPAL INVESTIGATOR
Janet Holbrook, PHD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Robert A. Wise, M.D
Study Record Dates
First Submitted
June 25, 2012
First Posted
June 28, 2012
Study Start
July 1, 2012
Primary Completion
October 1, 2014
Study Completion
December 1, 2014
Last Updated
May 15, 2017
Results First Posted
May 15, 2017
Record last verified: 2017-04