Trial record 2 of 239 for:    asthma [CONDITION] AND child [AGE-GROUP] | Open Studies

Severe Asthma Research Program - Wake Forest University (SARP3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Wake Forest School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eugene R. Bleecker, MD, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01750411
First received: December 12, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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.

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750411

Contacts
Contact: Eugene R Bleecker, MD 336-713-7520 ebleeck@wakehealth.edu
Contact: Wendy C Moore, MD 336-713-7520 wmoore@wakehealth.edu

Locations
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         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Eugene R Bleecker, MD Wake Forest School of Medicine
  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 School of Medicine:
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 August 28, 2014