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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01750411
Other study ID # IRB00021507
Secondary ID 1U10HL109164-01
Status Completed
Phase
First received
Last updated
Start date December 2012
Est. completion date January 15, 2021

Study information

Verified date February 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date January 15, 2021
Est. primary completion date February 18, 2020
Accepts healthy volunteers No
Gender All
Age group 6 Years and older
Eligibility 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 methacholine PC20=16 mg/mL. Exclusion Criteria: 1. No primary medical caregiver 2. Pregnancy (only if undergoing methacholine challenge or bronchoscopy) 3. Current smoking 4. 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) 5. 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 6. History of premature birth before 35 weeks gestation 7. Planning to relocate from the clinical center area before study completion

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Emory University Atlanta Georgia
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pulmonary function over time Pulmonary function test results include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). 36 months
Secondary Frequency of severe asthma exacerbations Frequency of severe asthma exacerbations
Utilization of hospital based care (Emergency Department, Hospitalization, ICU)
Need for supplemental oral corticosteroids
36 months
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