Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Brent Brown, MD; Phone Number: 405-271-6173; Email: brent-brown@ouhsc.edu
• Study Contact Backup: Name: Clinical Trials Manager; Email: research@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • OUHSC
      • Contact: Clinical Trials Manager; Email: research@ouhsc.edu
      • Contact: Brent Brown, MD; Phone Number: 405-271-6173
      • Principal Investigator: Brent Brown, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Retrospective review of Asthma Patients' records

Description

Inclusion Criteria:

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

Exclusion Criteria:

• < 18 years of age

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Past Bronchial Thermoplasty data; Data will be collected from records of patients who, in the past, have undergone bronchial thermoplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Brent Brown, MD, OUHSC

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimated): September 16, 2014

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: asthma; thermoplasty
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 3790 (Other Identifier: OUHSC IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified data may only be shared upon review of OUHSC Legal office and IRB. Data sharing agreement required. Contact research@ouhsc.edu to initiate data requests. No personally identifiable data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No