Severe Asthma Research Program

Conditions

Asthma

Keywords

Severe

Brief summary

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.

Detailed description

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.

Brendan K. Huang, Brett M. Elicker, Travis S. Henry, Kimberly Kallianos, Lewis D. Hahn et al. (24 authors)

JCI Insight2023-12-2117 citations

10.1172/jci.insight.174124

Development and initial validation of the Asthma Severity Scoring System (ASSESS).

Fitzpatrick AM, Szefler SJ, Mauger DT, Phillips BR, Denlinger LC, Moore WC, Sorkness RL, Wenzel SE, Gergen PJ, Bleecker ER, Castro M, Erzurum SC, Fahy JV, Gaston BM, Israel E, Levy BD, Meyers DA, Teague WG, Bacharier LB, Ly NP, Phipatanakul W, Ross KR, Zein J, Jarjour NN.

2019-10-0826 citations

10.1016/j.jaci.2019.09.018

Mucus plugs in patients with asthma linked to eosinophilia and airflow obstruction.

Dunican EM, Elicker BM, Gierada DS, Nagle SK, Schiebler ML, Newell JD, Raymond WW, Lachowicz-Scroggins ME, Di Maio S, Hoffman EA, Castro M, Fain SB, Jarjour NN, Israel E, Levy BD, Erzurum SC, Wenzel SE, Meyers DA, Bleecker ER, Phillips BR, Mauger DT, Gordon ED, Woodruff PG, Peters MC, Fahy JV, National Heart Lung and Blood Institute (NHLBI) Severe Asthma Research Program (SARP).

2018-02-05436 citations

10.1172/jci95693

ALX receptor ligands define a biochemical endotype for severe asthma

Isabell Ricklefs, Ioanna Barkas, Melody G. Duvall, Manuela Cernadas, N. Grossman et al. (22 authors)

JCI Insight2017-07-1934 citations

10.1172/jci.insight.93534

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Pulmonary function test results	36 months after enrollment	Pulmonary function test results include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).

Secondary

Measure	Time frame
Frequency of severe asthma exacerbations	36 months after enrollment

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSally Wenzel, MD

University of Pittsburgh

PRINCIPAL_INVESTIGATORElliot Israel, MD

Brigham & Women's Hospital, Boston

STUDY_CHAIRBruce Levy, MD

Brigham & Women's Hospital, Boston

PRINCIPAL_INVESTIGATORJohn Fahy, MD

University of California, San Francisco

PRINCIPAL_INVESTIGATORSuzy Comhair, MD

The Cleveland Clinic

PRINCIPAL_INVESTIGATORLoren Denlinger, MD

University of Wisconsin, Madison

PRINCIPAL_INVESTIGATORWendy Moore, MD

Wake Forest University Health Sciences

PRINCIPAL_INVESTIGATORMario Castro, MD

University of Kansas

PRINCIPAL_INVESTIGATORDavid Mauger, PhD

Penn State College of Medicine

Outcome results