Phenotyping Asthma for Bronchial Thermoplasty
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|ClinicalTrials.gov Identifier: NCT03435237|
Recruitment Status : Not yet recruiting
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
|Condition or disease|
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 symptoms.
The exact mechanisms behind the development of asthma are unknown. However, the excessive contraction of airway smooth muscle leading to airway constriction is thought to be responsible for the majority of the symptoms of asthma. A new treatment option, termed bronchial thermoplasty, can offer relief for individuals with severe asthma. Bronchial thermoplasty works by reducing smooth muscle with thermal energy.
This new imaging technology, called optical coherence tomography (OCT) is the first imaging modality that is capable to visualize airway smooth muscle in humans. In this study the investigators will examine the asthmatic airways before and after bronchial thermoplasty to learn about how airways respond to this treatment. The long term goal of this study is to use OCT to look at the airways with the hope of helping clinicians monitor and predict the response to bronchial thermoplasty.
During the scheduled bronchial thermoplasty procedure, OCT imaging will be performed. The study imaging will add less than 10 minutes to the time required for the standard procedure.Twelve months following the completion of bronchial thermoplasty, the investigators will ask the participants to return to the hospital to undergo follow-up tests including a CT scan and a bronchoscopy procedure with repeat OCT imaging. The investigators expect these test to be accomplished in 2 additional visits.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Phenotyping Asthma for Bronchial Thermoplasty: Airway Smooth Muscle Structure and Function|
|Anticipated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||December 2022|
- Evaluate OCT for assessing bronchial thermoplasty [ Time Frame: 1 year ]Does OCT imaging detect biomarkers that may predict patient's clinical response to bronchial thermoplasty as assessed by the Asthma Quality of Life Questionnaire.
- Evaluate OCT for assessing bronchial thermoplasty [ Time Frame: 1 year ]Does OCT imaging detect biomarkers that may predict patient's clinical response to bronchial thermoplasty as assessed by the pulmonary function tests.
- Evaluate OCT for assessing bronchial thermoplasty [ Time Frame: 1 year ]Does OCT imaging detect biomarkers that may predict patient's clinical response to bronchial thermoplasty as assessed by airway inflammation.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435237
|Contact: Melissa J Suter, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center||Not yet recruiting|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Melissa J Suter, PhD||Massachusetts General Hospital|