The Severe Asthma Research Program III-Boston Clinical Site

Completed

Conditions studied: Asthma

In brief

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).

Key facts

Study ID: NCT01761630
Run by: Elliot Israel, MD
People needed: 126
Starts: 2012-12-01
Expected to finish: 2021-01-15
Last updated by the study team: 2021-03-12

Who can join

Age: 6 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Ages 6-60
FEV1 bronchodilator reversibility ≥12% or methacholine PC20 ≤16 mg/mL
Ability to provide informed consent
Ability to perform pulmonary function tests

You may not qualify if…

Pregnancy (if undergoing methacholine challenge or bronchoscopy)
Current smoking
Smoking history > 10 pack years if ≥ 30 years of age or smoking history > 5 pack years if < 30 years of age (Note: If a subject has a smoking history, no smoking within the past year)
Other chronic pulmonary disorders associated with asthma-like symptoms, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction that is the sole cause of asthma symptoms, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways
Participants who cannot undergo bronchoscopy due to: 1) hospitalization for asthma within the 6 weeks prior to bronchoscopy, 2) > 12 asthma exacerbations within the 6 months prior to bronchoscopy, 3) intubation for asthma within the 6 months prior to bronchoscopy, 4) older than 60 years of age, 5) increased corticosteroid use in the 14 days prior to bronchoscopy. (Increased corticosteroid use recognized as a dose which is both numerically at least twice that of baseline, and which is at least 20 mg/day greater than the baseline dose.)
History of premature birth before 35 weeks gestation
Planning to relocate from the clinical center area before study completion
Currently participating in an investigational drug trial
Unwillingness to receive an intramuscular triamcinolone acetonide injection.

Where it is running

Boston Children's Hospital — Boston, Massachusetts, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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