Phase 2
Completed N=18
PEEP as Rescue Therapy for Asthmatics With Elevated BMI
Source: ClinicalTrials.gov NCT02696980 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Central and Peripheral Elastance — 391; 461; 587; 334 cmH2O/L
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Central and Peripheral Elastance |
391; 461; 587; 334; 103; 82 | — |
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
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. Informational only — not medical advice.