Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma

NCT ID: NCT02241265

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2026-09-30

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.

Conditions

Asthma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Past Bronchial Thermoplasty data

Data will be collected from records of patients who, in the past, have undergone bronchial thermoplasty.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• < 18 years of age

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brent Brown, MD

Role: PRINCIPAL_INVESTIGATOR

OUHSC

Locations

OUHSC

Oklahoma City, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brent Brown, MD

Role: CONTACT

brent-brown@ouhsc.edu

405-271-6173

Clinical Trials Manager

Role: CONTACT

research@ouhsc.edu

Facility Contacts

Brent Brown, MD

Role: primary

405-271-6173

Clinical Trials Manager

Role: backup

research@ouhsc.edu

Other Identifiers

3790

Identifier Type: OTHER

Identifier Source: secondary_id

3790

Identifier Type: -

Identifier Source: org_study_id