Increased Lung Volume as Controller Therapy for Asthma
Completed · Not applicable · Has a placebo group
Conditions studied: Asthma
In brief
This is an early phase clinical trial to test the efficacy of elevating lung volume with positive expiratory pressure (CPAP) as a controller therapy for asthma in patients with a BMI ≥ 30 kg/m2. There will be two phases to this trial. Phase I: In the first phase we will determine the optimal duration of CPAP that is effective as a controller therapy in asthma. Up to 9 participants will complete this this phase. Phase II: The 2nd phase will be a randomized double-blinded controlled trial of Sham CPAP versus CPAP 10 (using the duration of CPAP determined in phase I) as a controller therapy for asthma, and also to determine the effect o airway reactivity in healthy people with a BMI 30 kg/m2 and above. Twenty people with asthma and twenty controls will complete this phase.
Key facts
- Study ID
- NCT02953431
- Run by
- University of Vermont
- People needed
- 60
- Starts
- 2018-05-07
- Expected to finish
- 2023-12-31
- Last updated by the study team
- 2024-06-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- FEV1 < 60 % predicted
- Other significant disease that in the opinion of the investigator would interfere with study.
- Inability to perform required testing.
- Smoking within last 6 months.
- ≥ 20 pack year smoking history
- Inability to provide informed consent
- Pregnancy
- Known obstructive sleep apnea/ high likelihood of obstructive sleep apnea
- Asthma exacerbation in the prior 6 weeks
- Stoke or heart attack in the prior 3 months
- Known aortic aneurysm
- Renal failure
- A known severe heart, vascular, liver, renal, or hematological disease
- Active allergic rhinitis
- Recent eye surgery (within the last month)
Where it is running
- Vermont Lung Center — Colchester, Vermont, United States
Full record on ClinicalTrials.gov
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