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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham CPAP | Placebo Comparator | Participants will be randomized to Sham CPAP |
|
| CPAP 10 | Active Comparator | Participants will be randomized to CPAP 10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | CPAP will be administered with a CPAP machine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in impedance of lung in response to methacholine measured by forced oscillation | Average change in impedance in response to methacholine in participants assigned to Sham CPAP versus CPAP 10 | Through study completion, an average of one week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in spirometric lung function (FEV1 and FVC) | Average change in lung function in response to methacholine in participants assigned to Sham CPAP versus CPAP 10 | Through study completion, an average of one week |
| Change in asthma control |
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Inclusion Criteria for people with asthma:
Inclusion Criteria for controls:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Dixon, BM BCh | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vermont Lung Center | Colchester | Vermont | 05446 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25342709 | Result | Bates JH, Dixon AE. Potential role of the airway wall in the asthma of obesity. J Appl Physiol (1985). 2015 Jan 1;118(1):36-41. doi: 10.1152/japplphysiol.00684.2014. Epub 2014 Oct 23. | |
| 25138203 | Result | Chapman DG, Irvin CG, Kaminsky DA, Forgione PM, Bates JH, Dixon AE. Influence of distinct asthma phenotypes on lung function following weight loss in the obese. Respirology. 2014 Nov;19(8):1170-7. doi: 10.1111/resp.12368. Epub 2014 Aug 19. |
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Results will be published in the archival literature, and this will include a complete description of experimental and analytical methods used. All original data will be stored and available to interested investigators with appropriate regulatory approvals in place
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Average change in asthma control in response to methacholine in participants assigned to Sham CPAP versus CPAP 10
| Through study completion, an average of one week |
| 24821412 | Result | Al-Alwan A, Bates JH, Chapman DG, Kaminsky DA, DeSarno MJ, Irvin CG, Dixon AE. The nonallergic asthma of obesity. A matter of distal lung compliance. Am J Respir Crit Care Med. 2014 Jun 15;189(12):1494-502. doi: 10.1164/rccm.201401-0178OC. |
| 41225496 | Derived | Dixon AE, Garrow OJ, Duchene B, Martin F, Kaminsky DA, Callas P, Skloot GS, Bose SS, Bates JHT. A randomized trial of continuous positive airway pressure for the asthma of obesity. Respir Res. 2025 Nov 12;26(1):314. doi: 10.1186/s12931-025-03396-2. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |