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The Severe Asthma Research Program III-Boston Clinical Site

NCT01761630 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2021-03-12

No results posted yet for this study

Summary

Asthma is a disease characterized by inflammation in the airways. The body naturally makes compounds that reduce inflammation. Unfortunately, for patients with severe asthma, the pathway these compounds use to reduce inflammation seems to be perturbed. Investigators have chosen to focus on the anti-inflammatory compounds called lipoxins and how they work through the "ALX Axis", a name given to the ALX receptor pathway and its ligands. Work from the Brigham and Women's Hospital has suggested that in patients with severe asthma, the ALX axis may not work properly and therefore may not shut off inflammation as expected. Also, there is information to suggest that in some cases, steroids (prednisone and similar drugs), which are commonly used to treat asthma, may affect the ALX axis in a negative way, paradoxically making the inflammation worse instead of better.

As part of the NIH Severe Asthma Research Program the Asthma Research Center's goal is to identify what causes the problems in the ALX axis in severe asthma. To do so, participants with severe asthma will be compared to participants with milder forms of asthma. Investigators will use samples taken directly from the lungs of people with asthma, as well as blood, urine and CT scans of the lungs to better understand how the ALX axis changes both before and after corticosteroid treatment and throughout a three year span. Participants will come into the Asthma Research Center to have the procedures done.

Investigators expect participants will perform breathing tests and complete questionnaires and diaries. To better understand if corticosteroids negatively affect the ALX axis in severe asthma, researchers will take samples before and after a one time steroid injection equivalent to a prednisone treatment for asthma. Participants will perform two bronchoscopy procedures, before and after corticosteroid treatment, where biopsies and cells will be obtained from the participant's lungs. Investigators will use these samples to observe any changes that the corticosteroid may have on the ALX axis. At the end of the study, researchers at the Brigham and Women's Hospital expect to understand the ALX axis in such a way that will allow them to formulate new therapies and drug targets to treat people with asthma, especially severe asthma, more effectively.

In Boston, this study will be run together by the Asthma Research Center at the Brigham and Women's Hospital (adults) and Boston Children's Hospital (children).

Conditions

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Elliot Israel, MD

    lead OTHER

Principal Investigators

  • Elliot Israel, M.D. · Brigham and Women's Hospital/Harvard Medical School

  • Bruce Levy, M.D. · Brigham and Women's Hospital/Harvard Medical School

Eligibility

Min Age
6 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2020-03-15
Completion
2021-01-15

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01761630 on ClinicalTrials.gov