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N/A N=194 Randomized Triple-blind Treatment

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

Asthma

Enrolled (actual)
194
Serious AEs
1.0%
Results posted
May 2017
Primary outcome: Primary: Methacholine Reactivity — 2.13; 1.48; 1.44; 1.60 mg/mL — p=0.51

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Continuous Positive Airway Pressure device (Resmed, Swift, Mirage) (Device)
Age
Pediatric, Adult · 15+ yrs
Sex
All
Sponsor
American Lung Association Asthma Clinical Research Centers
Primary completion
Oct 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Methacholine Reactivity
2.13; 1.48; 1.44; 1.60; 1.37; 1.27 0.51

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.

Eligibility Criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01629823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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