Phenotyping Asthma for Bronchial Thermoplasty

Severe Asthma Clinical Trial

Official title:

Phenotyping Asthma for Bronchial Thermoplasty: Airway Smooth Muscle Structure and Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03435237
• Other study ID #: 2017P000962
• Secondary ID: 1R01HL133664-01A
• Status: Recruiting
• Start date: May 10, 2021
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: Massachusetts General Hospital
• Contact: Melissa J Suter, PhD
• Phone: 617-724-7691
• Email: msuter[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate OCT for assessing bronchial thermoplasty	Does OCT imaging detect biomarkers that may predict patient's clinical response to bronchial thermoplasty as assessed by the Asthma Quality of Life Questionnaire.	1 year
Primary	Evaluate OCT for assessing bronchial thermoplasty	Does OCT imaging detect biomarkers that may predict patient's clinical response to bronchial thermoplasty as assessed by the pulmonary function tests.	1 year
Primary	Evaluate OCT for assessing bronchial thermoplasty	Does OCT imaging detect biomarkers that may predict patient's clinical response to bronchial thermoplasty as assessed by airway inflammation.	1 year