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Severe Asthma | Phenotyping Asthma for Bronchial Thermoplasty

Severe Asthma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Severe Asthma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Not yet recruiting

Start Date: April 2018

Completed Date: December 2022

Phase: N/A

Type: Observational

Design:

Primary Outcome: Evaluate OCT for assessing bronchial thermoplasty

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Melissa J Suter, PhD

Lead Sponsor: Massachusetts General Hospital

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

More information:https://clinicaltrials.gov/show/NCT03435237

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