Evaluating airway responses in severe asthma treatment
Phenotyping Asthma for Bronchial Thermoplasty: Airway Smooth Muscle Structure and Function
Massachusetts General Hospital · NCT03435237
This study is testing a new imaging technique to see how well bronchial thermoplasty works for people with severe asthma by looking at their airways before and after the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT03435237 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of bronchial thermoplasty in patients with severe asthma using a novel imaging technology called optical coherence tomography (OCT). The study will visualize airway smooth muscle before and after the bronchial thermoplasty procedure to understand how the airways respond to this treatment. Participants will undergo OCT imaging during their scheduled bronchial thermoplasty, and follow-up tests will be conducted 12 months later to monitor changes in their condition. The ultimate goal is to enhance the management and long-term follow-up of severe asthma patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 who are undergoing elective bronchial thermoplasty for severe asthma.
Not a fit: Patients who are pregnant or have co-existing lung diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the monitoring and treatment outcomes for patients with severe asthma.
How similar studies have performed: While bronchial thermoplasty has been studied, the use of OCT for monitoring airway responses is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient undergoing elective bronchial thermoplasty 2. Patient is between the ages of 18 and 60 3. Patient is able to give informed consent 4. Negative pregnancy test for all female of childbearing potential who are sexually active and not using contraception, are seeking to become pregnant, or who are nursing. 5. Nonsmoking (\<5 pack year tobacco exposure) 6. No history of co-existing lung disease 7. Meet American Thoracic Society criteria for diagnosis of asthma with either/or 1. Bronchodilator response to albuterol (≥12% change in FEV1) 2. Positive methacholine bronchoprovocation (PC20 \< 25 mg/ml) Exclusion Criteria: 1. Patients who are pregnant. 2. Patient does not meet the requirements to undergo clinical bronchial thermoplasty, as determined by the treating physician
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Melissa J Suter, PhD — Massachusetts General Hospital
- Study coordinator: Melissa J Suter, PhD
- Email: msuter@mgh.harvard.edu
- Phone: 617-724-7691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Severe Asthma, Optical Coherence Tomography, Bronchial Thermoplasty