Recruiting

Bronchial Thermoplasty

Sponsor:

Massachusetts General Hospital

Code:

NCT03435237

Conditions

Severe Asthma

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT03435237

Start date

May 10, 2021

Status verified date

May, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Evaluate OCT for assessing bronchial thermoplasty [ Time Frame: 1 year ]
  • Evaluate OCT for assessing bronchial thermoplasty [ Time Frame: 1 year ]
  • Evaluate OCT for assessing bronchial thermoplasty [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 29, 2024

Last verified

May, 2024

Keywords

  • Optical Coherence Tomography
  • Bronchial Thermoplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2024-05-29.