NCT02953431Completed
Increased Lung Volume as Controller Therapy for Asthma
Source: ClinicalTrials.gov · Last updated 25 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 29 Apr 2016
- Start date
- 7 May 2018
- Primary completion date
- 1 Aug 2023
- Lead sponsor
- University of Vermont
- NCT number
- NCT02953431
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 7 May 2018 to the primary completion date, 1 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Asthma exacerbation in the prior 6 weeks
- Stoke or heart attack in the prior 3 months
- Recent eye surgery (within the last month)
Other illness
- Other significant disease that in the opinion of the investigator would interfere with study.
- Renal failure
- A known severe heart, vascular, liver, renal, or hematological disease
- Active allergic rhinitis
Other
- FEV1 \< 60 % predicted
- 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
- Known aortic aneurysm
Who the study is looking for
- Physician diagnosis of asthma
- PC20 to methacholine \< 16 mg/ml
- IgE \< 100 IU/ml
- Ages 18-65 years
- BMI \>=30 kg/m2
- No physician diagnosis of asthma
- PC20 to methacholine \> 16 mg/ml
- IgE \< 100 IU/ml
- Ages 18-65 years
- BMI \>=30 kg/m2
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vermont Lung Center Coordinator of this site? Confirm its status | Colchester | United States | Unknown status |
Related publications
- A randomized trial of continuous positive airway pressure for the asthma of obesity.Respir Res · 2025 · PMID 41225496
This page is information, not medical advice. Discuss any trial with your doctor.