Severe Asthma Research Program - Wake Forest University (SARP3)
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Purpose
The mission of SARP is to improve the understanding of severe asthma through the integrated study of the effect of genetics on the clinical and biological features of asthma and to investigate how these change over time. The ultimate goal of these efforts is to promote better treatments for severe asthma.
| Condition |
|---|
|
Asthma Severe Persistent Asthma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Severe Asthma Research Program at Wake Forest University - Longitudinal Phenomics and Genetics of Severe Asthma. |
- Change in pulmonary function over time [ Time Frame: 36 months ] [ Designated as safety issue: No ]Pulmonary function test results include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).
- Frequency of severe asthma exacerbations [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Frequency of severe asthma exacerbations
- Utilization of hospital based care (Emergency Department, Hospitalization, ICU)
- Need for supplemental oral corticosteroids
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: | December 2012 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Asthma
Severe Asthma Not severe 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, SARP investigators have each identified mechanistic research questions to be included in the shared longitudinal protocol. At Wake Forest University investigators are specifically interested in genetic influences on disease severity and the use of statistical modeling techniques to better understand disease phenotypes. 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: | No |
| Sampling Method: | Probability Sample |
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 all following eligibility criteria as outlined below:
Inclusion Criteria:
- Physician diagnosis of asthma,
- Age 6 years and older
Evidence of historical reversibility, including either:
- FEV1 bronchodilator reversibility ≥ 12%, or
- Airway hyperresponsiveness reflected by methacholine PC20≤16 mg/mL.
Exclusion Criteria:
- No primary medical caregiver
- Pregnancy (only if undergoing methacholine challenge or bronchoscopy)
- 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 asthma symptoms, 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
- Planning to relocate from the clinical center area before study completion
Contacts and Locations| Contact: Eugene R Bleecker, MD | 336-713-7520 | ebleeck@wakehealth.edu |
| Contact: Wendy C Moore, MD | 336-713-7520 | wmoore@wakehealth.edu |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Anne M Fitzpatrick, PhD 404-727-9112 anne.fitzpatrick@emory.edu | |
| Contact: Denise Whitlock 404-712-1773 drwhitl@emory.edu | |
| Sub-Investigator: Anne M Fitzpatrick, PhD | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Wendy C Moore, MD 336-713-7520 wmoore@wakehealth.edu | |
| Contact: Regina V Smith, BS 336-713-8550 rvsmith@wakehealth.edu | |
| Principal Investigator: Eugene R Bleecker, MD | |
| Sub-Investigator: Wendy C Moore, MD | |
| Sub-Investigator: Deborah A Meyers, PhD | |
| Sub-Investigator: Stephen P Peters, MD, PhD | |
| Sub-Investigator: Annette T Hastie, PhD | |
| Sub-Investigator: Gregory A Hawkins, PhD | |
| Principal Investigator: | Eugene R Bleecker, MD | Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eugene R. Bleecker, MD, Professor and Director, Center for Genomics and Personalized Medicine Research, Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01750411 History of Changes |
| Other Study ID Numbers: | SARP3, 1U10 HL109164-01, 1U10HL109164-01 |
| Study First Received: | December 12, 2012 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Data and Safety Monitoring Board United States: Federal Government United States: Institutional Review Board |
Keywords provided by Wake Forest University:
|
Severe Asthma SARP |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013