N/A
N=194
Effect of Positive Airway Pressure on Reducing Airway Reactivity in Patients With Asthma (CPAP)
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01629823 ↗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
| Outcome | Result | p-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.
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.