AsthmaNCT02953431
Increased Lung Volume as Controller Therapy for Asthma
A study testing CPAP in people with Asthma, run by University of Vermont at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- PC20 to methacholine > 16 mg/ml
- IgE < 100 IU/ml
- Ages 18-65 years
- BMI >=30 kg/m2
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Conditions
- Asthma
- Being tested
- CPAP
- Keywords
- Asthma, Obesity
- Medical subject headings
- Asthma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
CPAP will be administered with a CPAP machine
| Study group | Role | What they receive |
|---|---|---|
| Sham CPAP | Placebo comparator | Participants will be randomized to Sham CPAP Receives: Device: CPAP |
| CPAP 10 | Active comparator | Participants will be randomized to CPAP 10 Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of one week
Secondary outcomes (2)
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
Measured: Through study completion, an average of one week
Change in asthma control
Average change in asthma control in response to methacholine in participants assigned to Sham CPAP versus CPAP 10
Measured: Through study completion, an average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start7 May 2018
- Primary completion1 Aug 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Anne Dixon, University of Vermont
- Investigators
- Anne Dixon, BM BCh, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953431
- Sponsor's protocol ID
- 16-061
- Status last verified
- Jun 2024
- First submitted
- 29 Apr 2016
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 25342709Chapman 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.
PubMed 25138203Al-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.
PubMed 24821412Dixon 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.
PubMed 41225496
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Lung Volume as Controller Therapy for Asthma
- ClinicalTrials.gov ID
- NCT02953431
- Acronym / sponsor ID
- 16-061
- Conditions
- Asthma
- Keywords
- Asthma, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 7 May 2018 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham CPAP | Placebo comparator | Device: CPAPParticipants will be randomized to Sham CPAP |
| CPAP 10 | Active comparator | Device: CPAPParticipants will be randomized to CPAP 10 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Physician diagnosis of asthma
- PC20 to methacholine < 16 mg/ml
- IgE < 100 IU/ml
- Ages 18-65 years
- BMI >=30 kg/m2
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPCPAP will be administered with a CPAP machine | Device | CPAP 10, Sham CPAP |
Primary outcome
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
2 secondary outcomes
Change in spirometric lung function (FEV1 and FVC)
Time frame: Through study completion, an average of one week
Change in asthma control
Time frame: Through study completion, an average of one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Results publication: PubMed 25342709Bates 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.
- Results publication: PubMed 25138203Chapman 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.
- Results publication: PubMed 24821412Al-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.
- Derived from this study: PubMed 41225496Dixon 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.
- Individual participant dataSharing planned: Yes. 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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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Dixon, BM BCh principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Asthma, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in impedance of lung in response to methacholine measured by forced oscillation (time frame: Through study completion, an average of one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953431, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.