Phenotyping Asthma for Bronchial Thermoplasty

NCT03435237 | Recruiting

• 2 other identifiers: 2017P0009621R01HL133664-01A1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Severe Asthma

Keywords

Optical Coherence Tomography; Bronchial Thermoplasty

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Patient undergoing elective bronchial thermoplasty
• Patient is between the ages of 18 and 60
• Patient is able to give informed consent
• 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.
• Nonsmoking (\<5 pack year tobacco exposure)
• No history of co-existing lung disease
• Meet American Thoracic Society criteria for diagnosis of asthma with either/or
• Bronchodilator response to albuterol (≥12% change in FEV1)
• Positive methacholine bronchoprovocation (PC20 \< 25 mg/ml)

You may not qualify if:

• Patients who are pregnant.
• Patient does not meet the requirements to undergo clinical bronchial thermoplasty, as determined by the treating physician

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoalveolar lavage samples will be taken before and after the completion of the bronchial thermoplasty procedure to determine inflammation level of the lung.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Melissa J Suter, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa J Suter, PhD

CONTACT

617-724-7691; msuter@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: February 15, 2018
• Study Start: May 10, 2021
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)