Severe Asthma Research Program (SARP)
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| ClinicalTrials.gov Identifier: NCT01606826 |
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Recruitment Status :
Recruiting
First Posted : May 28, 2012
Last Update Posted : February 2, 2023
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Sponsor:
Milton S. Hershey Medical Center
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
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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 |
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 |
| 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, 2026 |
| Estimated Study Completion Date : | December 31, 2026 |
| Group/Cohort |
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Asthmatics
Subjects with active asthma.
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Healthy Controls
Subjects without any known pulmonary disease.
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Primary Outcome Measures :
- 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 :
- 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
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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:
- Physician diagnosis of asthma,
- Age 6 years and older
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Evidence of historical reversibility, including either:
- FEV1 bronchodilator reversibility ≥ 12%, or
- Airway hyperresponsiveness reflected by a methacholine PC20 ≤16 mg/mL.
Exclusion Criteria:
- 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:
Inclusion criteria: Healthy subjects between the age of 18 and 65 years. Exclusion criteria
- 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,
- Respiratory tract infection within the past 4 weeks,
- Pregnancy,
- 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
| Contact: David Mauger, PhD | 717-531-7178 | dmauger@psu.edu | |
| Contact: Kendall Baab | 717-531-7178 | kthomas@phs.psu.edu |
Locations
| 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
| 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):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | dave mauger, Professor of Public Health Sciences, Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT01606826 |
| Obsolete Identifiers: | NCT01761058 |
| Other Study ID Numbers: |
SARP003 1U10HL109086 ( U.S. NIH Grant/Contract ) |
| First Posted: | May 28, 2012 Key Record Dates |
| Last Update Posted: | February 2, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
Keywords provided by dave mauger, Milton S. Hershey Medical Center:
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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 |