Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma

Recruiting

• Conditions: Asthma

• Registration Number: NCT02241265
• Lead Sponsor: University of Oklahoma

Brief Summary

The investigators hypothesis is that there will be improvement in FEV1 in patients with severe asthma. This is a retrospective data study that reviews preexisting medical records; no patients will be enrolled.

Detailed Description

The investigators plan is to retrospectively evaluate spirometry on patients with severe asthma who have undergone bronchial thermoplasty. The procedure will have been done according to the recommended protocol of three separate sessions. For each patient all available spirometric data obtained before and after thermoplasty will be used. Data will be collected from two centers, OU Medical Center and St. Francis Hospital in Tulsa, OK. All procedures done at St. Francis have been performed by a single physician and he is providing their spirometric data for the investigators study. The following data will be collected for all participants undergoing bronchial thermoplasty: Age, height, sex, weight, medical history, smoking history, baseline spirometry before and after bronchodilators, post thermoplasty spirometry before and after bronchodilators.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-01
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• >18 years of age
• severe asthma diagnosis
• decreased FEV1

Exclusion Criteria

• < 18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoints are improvements in prebronchodilator FEV1 and FVC.	1 year after thermoplasty	The primary endpoints are improvements in prebronchodilator FEV1 and FVC by 12% predicted.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness.	1 year after thermoplasty	Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness by 12% predicted.

Trial Locations

Locations (1)

OUHSC; 🇺🇸 Oklahoma City, Oklahoma, United States