Increased Lung Volume as Controller Therapy for Asthma

NCT02953431 | Completed DMC FDA Device

• 1 other identifier: 16-061
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in spirometric lung function (FEV1 and FVC)

  Through study completion, an average of one week

• Change in asthma control

  Through study completion, an average of one week

Study Arms (2)

Sham CPAP

PLACEBO COMPARATOR

Participants will be randomized to Sham CPAP

Device: CPAP

CPAP 10

ACTIVE COMPARATOR

Participants will be randomized to CPAP 10

Device: CPAP

Interventions

CPAP DEVICE

CPAP will be administered with a CPAP machine

CPAP 10; Sham CPAP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• PC20 to methacholine \> 16 mg/ml
• IgE \< 100 IU/ml
• Ages 18-65 years
• BMI \>=30 kg/m2

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Vermont: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Vermont Lung Center

Colchester, Vermont, 05446, United States

Location

Related Publications (3)

• 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.

  PMID: 25342709 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.

  PMID: 25138203 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.

  PMID: 24821412 RESULT

MeSH Terms

Conditions

Asthma; Obesity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Dixon, BM BCh

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: November 2, 2016
• Study Start: May 7, 2018
• Primary Completion: August 1, 2023
• Study Completion: December 31, 2023
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)