Severe Asthma Research Program (SARP)- San Francisco Clinical Site

NCT01718197 | Completed DMC

• 2 other identifiers: SARP-SF5U10HL109146-04
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

The mission of 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 Asthma; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Lung function decline

  Changes in lung function parameters over time.

  Enrollment, 1 year, 2 years, 3 years

Secondary Outcomes (2)

• Exacerbation frequency

  Monthly for 3 years

• Inflammatory cellular markers

  Enrollment, 1 year, 2 years, 3 years

Study Arms (3)

Mild-to-Moderate Asthma

Those with mild-to-moderate persistent asthma as defined by the NAEPP EPR-3 guidelines.

Severe Asthma

Major Criteria: (1 required) 1. Treatment with oral corticosteroids for at least 6 of the previous 12 months 2. Treatment with high-dose inhaled corticosteroids (ICS) for at least 10 of the previous 12 months Minor Criteria: (2 required) 1. Daily treatment with an asthma controller medication in addition to ICS, or 2. Asthma symptoms requiring short-acting bronchodilator use on a daily or near daily basis, or 3. Persistent airway obstruction with baseline FEV1 \<80% predicted, or 4. ≥ 1 urgent visits for asthma in the previous 12 months, or 5. ≥ 3 systemic corticosteroid bursts in the previous 12 months, or 6. Prompt deterioration with a reduction in oral or inhaled corticosteroid dose, or 7. A near-fatal asthma event (i.e., intubation) in the past

Healthy Controls

Those without asthma or other chronic lung disease.

Eligibility Criteria

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

Study Population

A diverse sample of subjects with asthma is needed to gain better understanding of asthma and its endotypes. SARP will therefore enroll subjects 6 years and older with a physician diagnosis of asthma. The target recruitment goal for each center is 75% adults (age 18 and older) and 25% children age 6-17 years. Within the pediatric age group, an attempt will be made to enroll equal numbers of children 6-11 and 12-17 years of age. Similarly, an attempt will be made to enroll at least 50% females and 30% minorities.

You may qualify if:

• 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,
• 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.
• 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

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (2)

• 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

• 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

Related Links

• Severe Asthma Research Program Main Webpage
• UCSF Recruitment Website

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• John V Fahy, MD, MSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2012
• First Posted: October 31, 2012
• Study Start: November 1, 2012
• Primary Completion: February 18, 2020
• Study Completion: March 1, 2021
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1)