Severe Asthma Research Program



Status:Active, not recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:6 - Any
Updated:8/18/2018
Start Date:October 2012
End Date:December 2019

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The mission of the SARP is to improve the understanding of severe asthma through integrated
study of its clinical and biological features and to evaluate their changes over time. The
ultimate goal of these efforts is to promote better treatments for severe asthma.

The mission of the SARP is to improve the understanding of severe asthma to develop better
treatments. The SARP will gain a better understanding of asthma and its endotypes, in
children and adults, by defining the disease at the molecular and cellular levels in the
context of the temporal phenotypic expression of the disease. To this end, the SARP
investigators will utilize both mechanistic and evoked phenotype approaches to: 1)
characterize developmental molecular, cellular and physiologic phenotypes in children and
adults with mild to severe asthma, and 2) to further elucidate the evolving pathobiology and
pathogenesis of severe asthma and its sub-phenotypes and 3) compare these features over time.
This approach involves a shared longitudinal protocol conducted across all participating
centers which includes common information on all SARP participants. Additionally, the SARP
investigators have each identified mechanistic research questions to be included in the
shared longitudinal protocol. Together, these longitudinal and mechanistic approaches will
enable prediction of phenotype stability/fluctuation and pharmacologic responses and
identification of novel, disease-modifying targets for treatment.

Asthmatic Patients:

Inclusion Criteria:

1. Physician diagnosis of asthma,

2. Age 6 years and older

3. Evidence of historical reversibility, including either:

- FEV1 bronchodilator reversibility ≥ 12%, or

- Airway hyperresponsiveness reflected by a methacholine PC20 ≤16 mg/mL.

Exclusion Criteria:

1. Pregnancy during the characterization phase,

2. Current smoking,

3. 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),

4. 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 respiratory symptoms and
at the PI's discretion), severe scoliosis or chest wall deformities that affect lung
function, or congenital disorders of the lungs or airways,

5. History of premature birth before 35 weeks gestation,

6. Unwillingness to receive an intramuscular triamcinolone acetonide injection,

7. Evidence that the participant or family may be unreliable or poorly adherent to their
asthma treatment or study procedures,

8. Planning to relocate from the clinical center area before study completion,

9. Any other criteria that place the subject at unnecessary risk according to the
judgment of the Principal Investigator and/or attending physician(s) of record, or

10. Currently participating in an investigational drug trial for asthma therapies.

Healthy Controls:

Inclusion criteria: Healthy subjects between the age of 18 and 65 years. At least 3 of the
7 subjects per center should be aged 35 years or older.

Exclusion criteria

1. History of chronic diseases that affect the lungs,

2. A history suggestive of allergic rhinitis, eczema or chronic sinusitis,

3. An improvement in FEV1 of more than 12% following 4 puffs of albuterol,

4. Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years
if <30 years of age, or any smoking within the past year,

5. Respiratory tract infection within the past 4 weeks,

6. Pregnancy,

7. History of premature birth (<35 weeks).
We found this trial at
12
sites
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Boston, Massachusetts 02115
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Madison, Wisconsin 53706
(608) 263-2400
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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Saint Louis, Missouri 63110
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Saint Louis, MO
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San Francisco, California 94143
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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