PEEP as Rescue Therapy for Asthmatics With Elevated BMI

NCT02696980 | Completed Phase 1 Results DMC

• 1 other identifier: M16-060
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the effect of increasing lung volume with a simple hand-held device to both prevent, and also to relieve, airway constriction in people with asthma and a BMI ≥ 30 kg/m2. Twenty people with late onset non-allergic asthma and a BMI of ≥ 30 kg/m2 will be recruited. The efficacy of elevating lung volume on both preventing and reversing bronchoconstriction will be tested. Lung volume will be modulated by breathing out against a small level of resistance (positive expiratory pressure).

Conditions

Asthma

Keywords

obesity; asthma

Outcome Measures

Primary Outcomes (1)

• Central and Peripheral Elastance

  Investigators compare changes in respiratory system elastance to methacholine. Respiratory system impedance was measured at the 8-min time point and fit with the two-compartment series model of respiratory mechanics. The elastances of the central and distal compartments obtained from good quality fits of this model are reported for each of the following conditions: V2: PEP of 0 was administered during (0-4.5 min) and after (4.5-8 min) methacholine administration. V3: PEP of 0 was administered during (0-4.5 min) and PEP of 10 cmH2O after (4.5-8 min) methacholine administration. V4: This is a repeat of V2 above to test for stability of the response. V5: PEP of 10 cmH2O was administered both during (0-4.5 min) and after (4.5-8 min) methacholine administration. V1 was a baseline visit to establish physiologic parameters required for conducting Visits 2-5. There are no outcome measures for Visit 1.

  The end of the experiment (at the 8-min time point)

Study Arms (3)

Rescue

EXPERIMENTAL

Intervention: Positive expiratory pressure (PEEP) 10 will be applied after the administration of methacholine

Device: Positive Expiratory Pressure

Prophylaxis

EXPERIMENTAL

Intervention: Positive expiratory pressure (PEEP) 10 will be applied during the administration of methacholine

Device: Positive Expiratory Pressure

No PEEP

PLACEBO COMPARATOR

Intervention: Positive expiratory pressure (PEEP) 0 will be applied during the administration of methacholine

Device: Positive Expiratory Pressure

Interventions

Positive Expiratory Pressure DEVICE

Patient will exhale against positive expiratory pressure 0 mm or 10 mm while inhaling methacholine

Also known as: PEEP

No PEEP; Prophylaxis; Rescue

Eligibility Criteria

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

You may qualify if:

• PC20 to methacholine \< 16 mg/ml
• Asthma diagnosis when ≥ 18 years of age
• Serum Immunoglobulin E \< 100 IU/ml
• Ages ≥ 18 years
• BMI ≥ 30 kg/m2

You may not qualify if:

• Asthma exacerbation (defined as a hospitalization, ED visit, urgent care visit for asthma or new corticosteroids for asthma) in prior 6 weeks.
• Forced Expiratory Volume in 1 second \< 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

Vermont Lung Center

Colchester, Vermont, 05446, United States

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Asthma; Obesity

Interventions

Positive-Pressure Respiration

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

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Anne Dixon, MD
• Organization: University of Vermont

anne.dixon@uvm.edu

802 847 2700

Study Officials

• Anne Dixon, BM BCh

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 2, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 17, 2024
• Results First Posted: July 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Clinical study report published December 2021.

Locations

US (1)