Phase 2 N=18 Randomized Treatment

PEEP as Rescue Therapy for Asthmatics With Elevated BMI

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT02696980 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Central and Peripheral Elastance — 391; 461; 587; 334 cmH2O/L

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Positive Expiratory Pressure (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Vermont
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Central and Peripheral Elastance	391; 461; 587; 334; 103; 82	—

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).

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02696980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.