Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02241265

Enrollment

Registered

2014-09-16

Start date

2014-02-28

Completion date

2026-09-30

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, thermoplasty

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* \>18 years of age * severe asthma diagnosis * decreased FEV1

Exclusion criteria

* \< 18 years of age

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactBrent Brown, MD

brent-brown@ouhsc.edu405-271-6173

Backup ContactClinical Trials Manager

research@ouhsc.edu

Outcome results