Severe Asthma Research Program

NCT01606826 | Active Not Recruiting DMC

• 2 other identifiers: SARP0031U10HL109086
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 8

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.

Conditions

Asthma

Keywords

Severe

Outcome Measures

Primary Outcomes (1)

• Pulmonary function test results

  Pulmonary function test results include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).

  36 months after enrollment

Secondary Outcomes (1)

• Frequency of severe asthma exacerbations

  36 months after enrollment

Study Arms (2)

Asthmatics

Subjects with active asthma.

Healthy Controls

Subjects without any known pulmonary disease.

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target study population will is 80% adults (age 18 and older) and 20% children age 6-17 years, 50% females, and 30% minorities. Approximately 100 Healthy Control patients, matching the demographic characteristics of the asthma patients, will also be recruited in order to generate reference data for biospecimens collected from asthmatic patients.

You may qualify if:

• Physician diagnosis of asthma,
• Age 6 years and older
• Evidence of historical reversibility, including either:
• FEV1 bronchodilator reversibility ≥ 12%, or
• Airway hyperresponsiveness reflected by a methacholine PC20 ≤16 mg/mL.

You may not qualify if:

• Pregnancy during the characterization phase,
• 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 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,
• History of premature birth before 35 weeks gestation,
• Unwillingness to receive an intramuscular triamcinolone acetonide injection,
• Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures,
• Planning to relocate from the clinical center area before study completion,
• 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
• Currently participating in an investigational drug trial for asthma therapies.
• Healthy Controls:
• History of chronic diseases that affect the lungs,
• A history suggestive of allergic rhinitis, eczema or chronic sinusitis,
• An improvement in FEV1 of more than 12% following 4 puffs of albuterol,
• 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,

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (8)

University of California, San Francisco

San Francisco, California, 94143-0130, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital, Boston

Boston, Massachusetts, 02115, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (7)

• 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.

  PMID: 38127464 DERIVED

• 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.

  PMID: 33276117 DERIVED

• 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.

  PMID: 31622688 DERIVED

• 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.

  PMID: 31604088 DERIVED

• 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.

  PMID: 29400693 DERIVED

• 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.

  PMID: 28724795 DERIVED

• 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.

  PMID: 27967215 DERIVED

Related Links

• Severe Asthma Research Program (SARP) Public Website

Biospecimen

Retention: SAMPLES WITH DNA

Blood: CBC/Diff, Total IgE, Serum, Plasma, DNA, RNA; Urine; EBC; Sputum: Supernatant, Cell Pellet; Bronch: BAL, Bronchial Brushings, Bronchial Biopsy

MeSH Terms

Conditions

Asthma; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• Sally Wenzel, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Elliot Israel, MD

  Brigham & Women's Hospital, Boston

  PRINCIPAL INVESTIGATOR

• Bruce Levy, MD

  Brigham & Women's Hospital, Boston

  STUDY CHAIR

• John Fahy, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Suzy Comhair, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Loren Denlinger, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Wendy Moore, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Mario Castro, MD

  University of Kansas

  PRINCIPAL INVESTIGATOR

• David Mauger, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Public Health Sciences

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 28, 2012
• Study Start: October 1, 2012
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (8)