Severe Asthma Research Program (SARP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01606826
First received: May 24, 2012
Last updated: April 6, 2015
Last verified: April 2015
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Severe Asthma Research Program

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Pulmonary function test results [ Time Frame: 36 months after enrollment ] [ Designated as safety issue: No ]
    Pulmonary function test results include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).


Secondary Outcome Measures:
  • Frequency of severe asthma exacerbations [ Time Frame: 36 months after enrollment ] [ Designated as safety issue: No ]

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


Estimated Enrollment: 700
Study Start Date: October 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asthmatics

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Given the mission of SARP, a diverse sample of subjects with asthma is needed to gain better understanding of asthma and its endotypes. Because there are a number of respiratory disorders that may be confused with asthma or confound asthma assessment, SARP enrollees must meet the eligibility criteria as outlined below.

Approximately 49 Health Control patients, matching the demographic characteristics of the asthma patients, will also be recruited across the 7 site partnerships in order to generate reference data for biospecimens collected from asthmatic patients.

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 18y and 65y. At least 3 of the 7 subjects per center should be aged 35y or older.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606826

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0130
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Rainbow Babies and Children's Hospital, Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908-0386
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0225
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Study Chair: 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
Principal Investigator: John Fahy, MD University of California, San Francisco
Principal Investigator: Benjamin Gaston, MD Rainbow Babies and Children's Hospital, Case Western Reserve University
Principal Investigator: Nizar Jarjour, MD University of Wisconsin, Madison
Principal Investigator: Eugene Bleecker, MD Wake Forest School of Medicine
Principal Investigator: Mario Castro, MD Washington University School of Medicine
Principal Investigator: David T. Mauger, PhD Penn State College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: dave mauger, Professor of Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01606826     History of Changes
Other Study ID Numbers: SARP003, 1U10HL109086
Study First Received: May 24, 2012
Last Updated: April 6, 2015
Health Authority: United States: Federal Government

Keywords provided by Milton S. Hershey Medical Center:
Severe

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2015