Asthma
Conditions
Keywords
Asthma, Obesity
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
Interventions
DEVICECPAP
CPAP will be administered with a CPAP machine
Sponsors
Icahn School of Medicine at Mount Sinai
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
for people with asthma: 1. Physician diagnosis of asthma 2. PC20 to methacholine \< 16 mg/ml 3. IgE \< 100 IU/ml 4. Ages 18-65 years 5. BMI \>=30 kg/m2 Inclusion Criteria for controls: 1. No physician diagnosis of asthma 2. PC20 to methacholine \> 16 mg/ml 3. IgE \< 100 IU/ml 4. Ages 18-65 years 5. BMI \>=30 kg/m2
Exclusion criteria
1. FEV1 \< 60 % predicted 2. Other significant disease that in the opinion of the investigator would interfere with study. 3. Inability to perform required testing. 4. Smoking within last 6 months. 5. ≥ 20 pack year smoking history 6. Inability to provide informed consent 7. Pregnancy 8. Known obstructive sleep apnea/ high likelihood of obstructive sleep apnea 9. Asthma exacerbation in the prior 6 weeks 10. Stoke or heart attack in the prior 3 months 11. Known aortic aneurysm 12. Renal failure 13. A known severe heart, vascular, liver, renal, or hematological disease 14. Active allergic rhinitis 15. Recent eye surgery (within the last month)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in impedance of lung in response to methacholine measured by forced oscillation | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in spirometric lung function (FEV1 and FVC) | Through study completion, an average of one week | Average change in lung function in response to methacholine in participants assigned to Sham CPAP versus CPAP 10 |
| Change in asthma control | Through study completion, an average of one week | Average change in asthma control in response to methacholine in participants assigned to Sham CPAP versus CPAP 10 |
Countries
United States
Outcome results
None listed