Increased Lung Volume as Controller Therapy for Asthma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- University of Vermont
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in impedance of lung in response to methacholine measured by forced oscillation
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
The effect of 10 versus 0 cmH2O CPAP on airways responsiveness to inhaled methacholine will be studied using an adaptive "3+3" phase I/II study design. Dose Titration Phase (phase I): The efficacy of 8 hours of CPAP on airway responsiveness will be tested in three subjects. Efficacy will be defined as a 25% improvement in the impedance response to methacholine in all three subjects. If this occurs in all subjects, shorter durations of CPAP will be studied (4 hours then one hour). Conversely, if "dose escalation" is required, 3 nights, then 7 nights of CPAP will be studied. Randomized-controlled study phase (phase II): Participants will be randomized to CPAP 10 or Sham 0. The duration of CPAP will be determined in the dose titration phase. The effect on response to inhaled methacholine, lung function and asthma control will be determined in patients with asthma and a BMI ≥ 30 kg/m2, and also in healthy controls without asthma
Investigators
Anne Dixon
Professor of Medicine
University of Vermont
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Change in impedance of lung in response to methacholine measured by forced oscillation
Time Frame: Through study completion, an average of one week
Average change in impedance in response to methacholine in participants assigned to Sham CPAP versus CPAP 10
Secondary Outcomes
- Change in spirometric lung function (FEV1 and FVC)(Through study completion, an average of one week)
- Change in asthma control(Through study completion, an average of one week)