Phenotyping Asthma for Bronchial Thermoplasty

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

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Asthma

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 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
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Melissa J Suter, PhD; Phone Number: 617-724-7691; Email: msuter@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Melissa J Suter, PhD
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Adnan Majid, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Division of Pulmonary and Critical Care Medicine at Massachusetts General Hospital or Beth Israel Deaconess Medical Center for bronchial thermoplasty for the treatment of uncontrolled asthma will be eligible for recruitment.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Melissa J Suter, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; Bronchial Thermoplasty
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2017P000962; 1R01HL133664-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No