Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- University of Oklahoma
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The primary endpoints are improvements in prebronchodilator FEV1 and FVC.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\>18 years of age
- •severe asthma diagnosis
- •decreased FEV1
Exclusion Criteria
- •\< 18 years of age
Outcomes
Primary Outcomes
The primary endpoints are improvements in prebronchodilator FEV1 and FVC.
Time Frame: 1 year after thermoplasty
The primary endpoints are improvements in prebronchodilator FEV1 and FVC by 12% predicted.
Secondary Outcomes
- Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness.(1 year after thermoplasty)