Status:
RECRUITING
Phenotyping Asthma for Bronchial Thermoplasty
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Severe Asthma
Eligibility:
All Genders
18-60 years
Brief Summary
This study will evaluate a new imaging technology, called optical coherence tomography (OCT) to examine the asthmatic airways before and after bronchial thermoplasty, which is a new treatment option f...
Detailed Description
Asthma currently affects over 300 million individuals worldwide and the number of the affected patient is continuously increasing. Approximately 10% of asthmatics have poorly controlled, severe sympto...
Eligibility Criteria
Inclusion
- Patient undergoing elective bronchial thermoplasty
- Patient is between the ages of 18 and 60
- Patient is able to give informed consent
- 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.
- Nonsmoking (\<5 pack year tobacco exposure)
- No history of co-existing lung disease
- Meet American Thoracic Society criteria for diagnosis of asthma with either/or
- Bronchodilator response to albuterol (≥12% change in FEV1)
- Positive methacholine bronchoprovocation (PC20 \< 25 mg/ml)
Exclusion
- Patients who are pregnant.
- Patient does not meet the requirements to undergo clinical bronchial thermoplasty, as determined by the treating physician
Key Trial Info
Start Date :
May 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03435237
Start Date
May 10 2021
End Date
December 1 2024
Last Update
May 29 2024
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215