NCT02241265

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
3mo left

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Feb 2014Sep 2026

Study Start

First participant enrolled

February 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

11.9 years

First QC Date

May 5, 2014

Last Update Submit

February 6, 2025

Conditions

Asthma

Keywords

asthmathermoplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    1 year after thermoplasty

Study Arms (1)

Past Bronchial Thermoplasty data

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective review of Asthma Patients' records

You may qualify if:

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

You may not qualify if:

  • \< 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OUHSC

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Brent Brown, MD

    OUHSC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brent Brown, MD

CONTACT

405-271-6173brent-brown@ouhsc.edu

Clinical Trials Manager

CONTACT

research@ouhsc.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2014

First Posted

September 16, 2014

Study Start

February 1, 2014

Primary Completion

January 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)