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Procedure

Image Guided Bronchial Thermoplasty for Asthma

N/A
Waitlist Available
Led By Grace E Parraga, PhD
Research Sponsored by Dr. Grace Parraga
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
Beta-agonist reversibility of FEV1>12%, OR Methacholine FEV1 PC20 ≤ 8 mg/ml if not receiving ICS or ≤ 16mg/ml if receiving an ICS.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 +/- 2 weeks post bronchial thermoplasty
Awards & highlights

Study Summary

This trial is comparing two ways to do bronchial thermoplasty, a treatment for severe asthma. One way uses images to guide the treatment, and the other does not.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 +/- 2 weeks post bronchial thermoplasty treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 +/- 2 weeks post bronchial thermoplasty treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Whole lung and lobe specific ventilation defect percent (VDP) as measured by 3He or 129Xe
Secondary outcome measures
Dyspnea Scales
Pulmonary function measurements
Quality of Life questionnaires

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Image guided bronchial thermoplastyExperimental Treatment1 Intervention
At pre-treatment Visit 3, imaging data will be acquired to generate a patient-specific bronchial thermoplasty treatment plan which will include 15-20 target airways, prioritized in order of importance and grouped by lobe, to be targeted during a single session BT treatment procedure. Airways demonstrating dynamic or static bronchoconstriction will be targeted for BT treatment based on their spacial proximity to ventilation defects.
Group II: Conventional bronchial thermoplastyActive Control1 Intervention
Patients in this group will undergo conventional 3 stage bronchial thermoplasty (during 3 separate bronchoscopies).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Image Guided Bronchial Thermoplasty
2014
N/A
~30

Find a Location

Who is running the clinical trial?

Dr. Grace ParragaLead Sponsor
5 Previous Clinical Trials
459 Total Patients Enrolled
4 Trials studying Asthma
259 Patients Enrolled for Asthma
McMaster UniversityOTHER
877 Previous Clinical Trials
2,596,035 Total Patients Enrolled
19 Trials studying Asthma
894 Patients Enrolled for Asthma
Grace E Parraga, PhDPrincipal InvestigatorRobarts Research Institute, The University of Western Ontario
14 Previous Clinical Trials
1,338 Total Patients Enrolled
4 Trials studying Asthma
259 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025