NCT03435237 Phenotyping Asthma for Bronchial Thermoplasty
| NCT ID | NCT03435237 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Severe Asthma |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-05-10 |
| Primary Completion | 2024-10 |
Trial Parameters
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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 for severe asthmatic patients. The aim of this study is to learn more about how airways respond to this new treatment. In the future the investigators hope OCT will aid clinicians in the initial assessment, management and long-term follow up of patients receiving bronchial thermoplasty.
Eligibility 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
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