Increased Lung Volume as Controller Therapy for Asthma
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ClinicalTrials.gov Identifier: NCT02953431 |
Recruitment Status :
Recruiting
First Posted : November 2, 2016
Last Update Posted : May 31, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Device: CPAP | Phase 1 Phase 2 |
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
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Increased Lung Volume as Controller Therapy for Asthma |
Actual Study Start Date : | May 7, 2018 |
Estimated Primary Completion Date : | August 2022 |
Estimated Study Completion Date : | April 2023 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Sham CPAP
Participants will be randomized to Sham CPAP
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Device: CPAP
CPAP will be administered with a CPAP machine |
Active Comparator: CPAP 10
Participants will be randomized to CPAP 10
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Device: CPAP
CPAP will be administered with a CPAP machine |
- 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
- Change in spirometric lung function (FEV1 and FVC) [ Time Frame: 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 [ Time Frame: 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for people with asthma:
- Physician diagnosis of asthma
- PC20 to methacholine < 16 mg/ml
- IgE < 100 IU/ml
- Ages 18-65 years
- BMI >=30 kg/m2
Inclusion Criteria for controls:
- No physician diagnosis of asthma
- PC20 to methacholine > 16 mg/ml
- IgE < 100 IU/ml
- Ages 18-65 years
- BMI >=30 kg/m2
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
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953431
Contact: Anne Dixon, BM BCh | 802 656 3525 | anne.dixon@uvm.edu | |
Contact: Olivia Johnson, MS, RDN | 802-847-2160 | olivia.johnson@uvmhealth.org |
United States, Vermont | |
Vermont Lung Center | Recruiting |
Colchester, Vermont, United States, 05446 | |
Contact: Olivia Johnson, MS, RDN 802-847-2160 olivia.johnson@uvmhealth.org |
Principal Investigator: | Anne Dixon, BM BCh | University of Vermont |
Responsible Party: | Anne Dixon, Professor of Medicine, University of Vermont |
ClinicalTrials.gov Identifier: | NCT02953431 |
Other Study ID Numbers: |
16-061 |
First Posted: | November 2, 2016 Key Record Dates |
Last Update Posted: | May 31, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Asthma Obesity |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |