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NCT Number: NCT02241265

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.

Recruiting

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

OUHSC

Oklahoma City, Oklahoma, 73104, United States

Location status: Recruiting

Location contact

Brent Brown, MD

CONTACT

405-271-6173

Brent Brown, MD

PRINCIPAL_INVESTIGATOR

Clinical Trials Manager

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • < 18 years of age

Treatment and study plan

Primary outcomes

  1. 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

  1. Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness.

    Time frame: 1 year after thermoplasty

    Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness by 12% predicted.

Study contacts

Contact information is provided by the study sponsor or research team.

Brent Brown, MD

CONTACT

[email protected]

405-271-6173

Clinical Trials Manager

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2014
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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