Severe Asthma Research Program (SARP)

July 25, 2023 updated by: dave mauger, Milton S. Hershey Medical Center
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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: David Mauger, PhD
  • Phone Number: 717-531-7178
  • Email: dmauger@psu.edu

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143-0130
        • University of California, San Francisco
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women'S Hospital
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital, Boston
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin-Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Asthmatics
Subjects with active asthma.
Healthy Controls
Subjects without any known pulmonary disease.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of severe asthma exacerbations
Time Frame: 36 months after enrollment
36 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Sally Wenzel, MD, University of Pittsburgh
  • Principal Investigator: Elliot Israel, MD, Brigham & Women's Hospital, Boston
  • Study Chair: Bruce Levy, MD, Brigham & Women's Hospital, Boston
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

May 25, 2012

First Posted (Estimated)

May 28, 2012

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SARP003
  • 1U10HL109086 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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