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 range
15 Years – 60 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Methacholine Reactivity
Timeframe: 12 weeks after randomization
Trial details
NCT IDNCT01629823
SponsorAmerican Lung Association Asthma Clinical Research Centers