Effect of Positive Airway Pressure on Reducing Airway Reactivity in Patients With Asthma (CPAP)

Completed · Not applicable

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01629823

Run by

American Lung Association Asthma Clinical Research Centers

People needed

209

Starts

2012-07-01

Expected to finish

2014-12-01

Last updated by the study team

2017-05-15

Who can join

Age: 15 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 15 - 60 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.

Where it is running

• 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, 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

Full record on ClinicalTrials.gov

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