Severe Asthma Research Program

NCT ID: NCT01606826

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2026-12-31

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.

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Asthmatics

Subjects with active asthma.

No interventions assigned to this group

Healthy Controls

Subjects without any known pulmonary disease.

No interventions assigned to this group

Eligibility Criteria

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.

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).

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:

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

dave mauger

Professor of Public Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sally Wenzel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Elliot Israel, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham & Women's Hospital, Boston

Bruce Levy, MD

Role: STUDY_CHAIR

Brigham & Women's Hospital, Boston

John Fahy, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Suzy Comhair, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Loren Denlinger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Wendy Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Mario Castro, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

David Mauger, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

University of California, San Francisco

San Francisco, California, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Children's Hospital, Boston

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Countries

United States

References

Huang BK, Elicker BM, Henry TS, Kallianos KG, Hahn LD, Tang M, Heng F, McCulloch CE, Bhakta NR, Majumdar S, Choi J, Denlinger LC, Fain SB, Hastie AT, Hoffman EA, Israel E, Jarjour NN, Levy BD, Mauger DT, Sumino K, Wenzel SE, Castro M, Woodruff PG, Fahy JV, Sarp FTNSARP. Persistent mucus plugs in proximal airways are consequential for airflow limitation in asthma. JCI Insight. 2024 Feb 8;9(3):e174124. doi: 10.1172/jci.insight.174124.

Reference Type: DERIVED

PMID: 38127464 (View on PubMed)

Coverstone AM, Boomer JS, Lew D, Bacharier LB, Castro M; Severe Asthma Research Program (SARP) Investigators. Type 2 inflammation in the sputum of adolescents with asthma. Ann Allergy Asthma Immunol. 2021 Mar;126(3):297-299. doi: 10.1016/j.anai.2020.11.018. Epub 2020 Dec 2. No abstract available.

Reference Type: DERIVED

PMID: 33276117 (View on PubMed)

Ross KR, Gupta R, DeBoer MD, Zein J, Phillips BR, Mauger DT, Li C, Myers RE, Phipatanakul W, Fitzpatrick AM, Ly NP, Bacharier LB, Jackson DJ, Celedon JC, Larkin A, Israel E, Levy B, Fahy JV, Castro M, Bleecker ER, Meyers D, Moore WC, Wenzel SE, Jarjour NN, Erzurum SC, Teague WG, Gaston B. Severe asthma during childhood and adolescence: A longitudinal study. J Allergy Clin Immunol. 2020 Jan;145(1):140-146.e9. doi: 10.1016/j.jaci.2019.09.030. Epub 2019 Oct 14.

Reference Type: DERIVED

PMID: 31622688 (View on PubMed)

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. Development and initial validation of the Asthma Severity Scoring System (ASSESS). J Allergy Clin Immunol. 2020 Jan;145(1):127-139. doi: 10.1016/j.jaci.2019.09.018. Epub 2019 Oct 8.

Reference Type: DERIVED

PMID: 31604088 (View on PubMed)

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). Mucus plugs in patients with asthma linked to eosinophilia and airflow obstruction. J Clin Invest. 2018 Mar 1;128(3):997-1009. doi: 10.1172/JCI95693. Epub 2018 Feb 5.

Reference Type: DERIVED

PMID: 29400693 (View on PubMed)

Ricklefs I, Barkas I, Duvall MG, Cernadas M, Grossman NL, Israel E, Bleecker ER, Castro M, Erzurum SC, Fahy JV, Gaston BM, Denlinger LC, Mauger DT, Wenzel SE, Comhair SA, Coverstone AM, Fajt ML, Hastie AT, Johansson MW, Peters MC, Phillips BR, Levy BD; National Heart Lung and Blood Institute's Severe Asthma Research Program-3 Investigators. ALX receptor ligands define a biochemical endotype for severe asthma. JCI Insight. 2017 Jul 20;2(14):e93534. doi: 10.1172/jci.insight.93534. eCollection 2017 Jul 20.

Reference Type: DERIVED

PMID: 28724795 (View on PubMed)

Phipatanakul W, Mauger DT, Sorkness RL, Gaffin JM, Holguin F, Woodruff PG, Ly NP, Bacharier LB, Bhakta NR, Moore WC, Bleecker ER, Hastie AT, Meyers DA, Castro M, Fahy JV, Fitzpatrick AM, Gaston BM, Jarjour NN, Levy BD, Peters SP, Teague WG, Fajt M, Wenzel SE, Erzurum SC, Israel E; Severe Asthma Research Program. Effects of Age and Disease Severity on Systemic Corticosteroid Responses in Asthma. Am J Respir Crit Care Med. 2017 Jun 1;195(11):1439-1448. doi: 10.1164/rccm.201607-1453OC.

Reference Type: DERIVED

PMID: 27967215 (View on PubMed)

Related Links

http://www.severeasthma.org/

Severe Asthma Research Program (SARP) Public Website

Other Identifiers

1U10HL109086

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SARP003

Identifier Type: -

Identifier Source: org_study_id

NCT01761058

Identifier Type: -

Identifier Source: nct_alias