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Increased Lung Volume as Controller Therapy for Asthma

Primary Purpose

Asthma

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CPAP

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Vermont Lung CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sham CPAP

CPAP 10

Arm Description

Participants will be randomized to Sham CPAP

Participants will be randomized to CPAP 10

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Change in asthma control

Average change in asthma control in response to methacholine in participants assigned to Sham CPAP versus CPAP 10

Full Information

NCT ID

NCT02953431

First Posted

April 29, 2016

Last Updated

March 17, 2023

Sponsor

University of Vermont

Collaborators

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT02953431

Brief Title

Increased Lung Volume as Controller Therapy for Asthma

Official Title

Increased Lung Volume as Controller Therapy for Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 7, 2018 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Vermont

Collaborators

Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sham CPAP

Arm Type

Placebo Comparator

Arm Description

Participants will be randomized to Sham CPAP

Arm Title

CPAP 10

Arm Type

Active Comparator

Arm Description

Participants will be randomized to CPAP 10

Intervention Type

Device

Intervention Name(s)

CPAP

Intervention Description

CPAP will be administered with a CPAP machine

Primary Outcome Measure Information:

Title

Change in impedance of lung in response to methacholine measured by forced oscillation

Description

Average change in impedance in response to methacholine in participants assigned to Sham CPAP versus CPAP 10

Time Frame

Through study completion, an average of one week

Secondary Outcome Measure Information:

Title

Change in spirometric lung function (FEV1 and FVC)

Description

Average change in lung function in response to methacholine in participants assigned to Sham CPAP versus CPAP 10

Time Frame

Through study completion, an average of one week

Title

Change in asthma control

Description

Average change in asthma control in response to methacholine in participants assigned to Sham CPAP versus CPAP 10

Time Frame

Through study completion, an average of one week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anne Dixon, BM BCh

Phone

802 656 3525

anne.dixon@uvm.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Olivia Johnson, MS, RDN

Phone

802-847-2160

olivia.johnson@uvmhealth.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Dixon, BM BCh

Organizational Affiliation

University of Vermont

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vermont Lung Center

City

Colchester

State/Province

Vermont

ZIP/Postal Code

05446

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivia Johnson, MS, RDN

Phone

802-847-2160

olivia.johnson@uvmhealth.org

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

25342709

Citation

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.

Results Reference

result

PubMed Identifier

25138203

Citation

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.

Results Reference

result

PubMed Identifier

24821412

Citation

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.

Results Reference

result

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Increased Lung Volume as Controller Therapy for Asthma

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