Effect of Positive Airway Pressure on Reducing Airway Reactivity in Patients With Asthma (CPAP) (NCT01629823) | Clinical Trial Compass
CompletedNot Applicable
Effect of Positive Airway Pressure on Reducing Airway Reactivity in Patients With Asthma (CPAP)
United States209 participantsStarted 2012-07
Plain-language 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.
Who can participate
Age range15 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
What they're measuring
1
Methacholine Reactivity
Timeframe: 12 weeks after randomization
Trial details
NCT IDNCT01629823
SponsorAmerican Lung Association Asthma Clinical Research Centers