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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Melissa J. Suter, Massachusetts General Hospital

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.

Condition or disease
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
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phenotyping Asthma for Bronchial Thermoplasty: Airway Smooth Muscle Structure and Function
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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
Bronchoalveolar lavage samples will be taken before and after the completion of the bronchial thermoplasty procedure to determine inflammation level of the lung.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Melissa J Suter, PhD 617-724-7691 msuter@mgh.harvard.edu

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

Responsible Party: Melissa J. Suter, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03435237     History of Changes
Other Study ID Numbers: 2017P000962
1R01HL133664-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Melissa J. Suter, Massachusetts General Hospital:
Optical Coherence Tomography
Bronchial Thermoplasty

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases