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Severe Asthma Research Program (SARP)

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ClinicalTrials.gov Identifier: NCT01606826
Recruitment Status : Recruiting
First Posted : May 28, 2012
Last Update Posted : February 2, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Severe Asthma Research Program
Actual Study Start Date : October 2012
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Frequency of severe asthma exacerbations [ Time Frame: 36 months after enrollment ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606826


Contacts
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Contact: David Mauger, PhD 717-531-7178 dmauger@psu.edu
Contact: Kendall Baab 717-531-7178 kthomas@phs.psu.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143-0130
Contact: Kelly Wong McGrath    415-476-5043    Kelly.Wong@nursing.ucsf.edu   
Principal Investigator: John Fahy, MD         
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Brittany Dioneda    617-732-6641    bfopmrfs@partners.org   
Principal Investigator: Elliot Israel, MD         
Principal Investigator: Bruce Levy, MD         
Children's Hospital, Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Amparito Cunningham    857-218-5531    Amparito.cunningham@childrens.harvard.edu   
Sub-Investigator: Wanda Phipatanakul, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Rachel Weaver    314-362-3627    rweaver@dom.wustl.edu   
Principal Investigator: Mario Castro, MD         
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Regina Smith    336-713-8551    rvsmith@wakehealth.edu   
Principal Investigator: Eugene Bleecker, MD         
United States, Ohio
Rainbow Babies and Children's Hospital, Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Laurie Logan    216-844-7927    Laurie.Logan@UHhospitals.org   
Sub-Investigator: James Chmiel, MD         
Principal Investigator: Benjamin Gaston, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Emmea Mattox    216-636-5149    cleggee@ccf.org   
Sub-Investigator: Serpil Erzurum, MD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Louise Martin, BSN CCRC    412-692-4747    martinlp@upmc.edu   
Principal Investigator: Sally Wenzel, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908-0386
Contact: Kristin Wavell    434-924-6874    kww7d@virginia.edu   
Sub-Investigator: Gerald Teague, MD         
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Gina Crisafi    608-263-0524    pulm-research@medicine.wisc.edu   
Principal Investigator: Nizar Jarjour, MD         
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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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
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: dave mauger, Professor of Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01606826    
Other Study ID Numbers: SARP003
1U10HL109086 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2012    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by dave mauger, Milton S. Hershey Medical Center:
Severe
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases