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Severe Asthma Research Program - Wake Forest University (SARP3)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750411
First Posted: December 17, 2012
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
  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.

Further study details as provided by Wake Forest University Health Sciences ( Wake Forest University ):

Primary Outcome Measures:
  • Change in pulmonary function over time [ Time Frame: 36 months ]
    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 ]

    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: March 1, 2018
Estimated Primary Completion Date: March 1, 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 all following eligibility criteria as outlined below:

Criteria

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
  Contacts and Locations
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): NCT01750411


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Eugene R Bleecker, MD University of Arizona Department of Medicine
Principal Investigator: Deborah A Meyers, PhD University of Arizona Department of Medicine
Principal Investigator: Wendy C Moore, MD Wake Forest University Health Sciences
  More Information

Additional Information:
Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT01750411     History of Changes
Other Study ID Numbers: SARP3, 1U10 HL109164-01
1U10HL109164-01 ( U.S. NIH Grant/Contract )
First Submitted: December 12, 2012
First Posted: December 17, 2012
Last Update Posted: November 6, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences ( 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