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NCT02241265 Clinical Trial

Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma

Asthma Clinical Trial

Official title:
Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02241265
Other study ID # 3790
Secondary ID 3790
Status Recruiting
Phase
First received
Last updated
Start date February 2014
Est. completion date September 2025

Study information
Verified date December 2023
Source University of Oklahoma
Contact Brent Brown, MD
Phone 405-271-6173
Email brent-brown@ouhsc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date September 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - >18 years of age - severe asthma diagnosis - decreased FEV1 Exclusion Criteria: - < 18 years of age

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States OUHSC Oklahoma City Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary endpoints are improvements in prebronchodilator FEV1 and FVC. The primary endpoints are improvements in prebronchodilator FEV1 and FVC by 12% predicted. 1 year after thermoplasty
Secondary Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness. Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness by 12% predicted. 1 year after thermoplasty
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