Increased Lung Volume as Controller Therapy for Asthma

March 17, 2023 updated by: Anne Dixon, University of Vermont

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sham CPAP
Participants will be randomized to Sham CPAP
Device: CPAP
CPAP will be administered with a CPAP machine
Active Comparator: CPAP 10
Participants will be randomized to CPAP 10
Device: CPAP
CPAP will be administered with a CPAP machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of one week
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
Through study completion, an average of one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Anne Dixon, BM BCh, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2018

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

April 29, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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