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Severe Asthma Research Program - University of Virginia (SARP3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Virginia
Sponsor:
Collaborators:
Case Western Reserve University
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT01761058
First received: January 2, 2013
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

The overall goal of this proposal is to better understand the basis of airway remodeling in severe asthma and how remodeling changes overtime. The investigators propose to study a well characterized cohort of individuals with severe asthma using a multidisciplinary state-of-the-art-approach.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Severe Asthma Research Program at University of Virginia - Airway Redox Biochemistry as a Determinant of Asthma Phenotype During Adolescence

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Lung Function [ Time Frame: baseline and 3 years ] [ Designated as safety issue: No ]
    decline in lung function (FEV1) over 3 years


Secondary Outcome Measures:
  • Asthma Control Questionnaire [ Time Frame: baseline and 3 years ] [ Designated as safety issue: No ]
    change in score in ACQ. Subjects report having worst asthma symptoms.

  • Puberty Changes [ Time Frame: baseline and 3 years ] [ Designated as safety issue: No ]
    Lung function will worsen in girls with severe asthma at the time of menarche and the decline will be greater in women with severe asthma than men. And fewer girls than boys will outgrow severe asthma during puberty

  • Exacerbation [ Time Frame: baseline and 3 years ] [ Designated as safety issue: No ]
    Exacerbation requiring systemic steroids


Biospecimen Description:

Blood: CBC/DIFF, total IgE, Serum, plasma, DNA, RNA, sputum, urine, exhaled breath condensate


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Severe Asthma
Subjects with Severe Asthma (SARP protocol definition)
Well controlled asthma
subjects with well controlled asthma

Detailed Description:

Through innovative metabolomics and redox biochemistry, methodologies that are a strength and unique to our collaborative efforts, the investigators identified clinically relevant phenotypes of asthma. The phenotypes are defined by biomarkers specific to underlying biochemical mechanistic abnormalities, including eosinophil-mediated oxidation, depletion of antioxidants and protective airway S-nitrosothiols, and airway acidification. Here,the investigators propose to study a new component that is informative for longitudinal assessment of severe asthma phenotypes: gender effects. The investigators reason that identification of the metabolic mechanism(s) underlying onset of severe asthma in young women during adolescence, and resolution of severe asthma in boys, will reveal fundamental pathophysiology of severe asthma. Importantly, we aim to develop clinical testing procedures to accurately assign metabolic asthma phenotypes; and to follow patients in each phenotype to uncover clinical longitudinal outcomes. At the conclusion of the project, we anticipate that we will have 1) developed clinically relevant tests to identify severe asthma phenotypes; 2) determined the longitudinal outcome of the phenotypes; and 3) identified the mechanisms underlying the preponderance of women in the severe asthma population. This application will focus on the development or clinically relevant metabolic tests to identify subphenotypes of adults and children with severe asthma and will lead to new targeted innovative treatments.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children with asthma (severe, well controlled)from the Charlottesville enactment area.

Criteria

Inclusion Criteria:

Physician diagnosis of asthma

• Age 6 years to 17 years old Evidence of historical reversibility, including either;

  1. FEV1 bronchodilator reversibility greater than or equal to 12%, or
  2. Airway hyperresponsivesness reflected by a methacholine PC20 less than or equal to 16 mg/ml.

Exclusion Criteria:

  • Exclusion criteria include any of the following:

    1. Pregnancy during the characterization phase*,
    2. Current smoking,
    3. 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),
    4. 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,
    5. History of premature birth before 35 weeks gestation,
    6. Unwillingness to receive an intramuscular triamcinolone acetonide injection.
    7. Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures,
    8. Planning to relocate from the clinical center area before study completion,
    9. 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
    10. Currently participating in an investigational drug trial.
  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: NCT01761058

Contacts
Contact: Donna L Wolf, PhD 434-982-4206 dlw9t@virginia.edu
Contact: Kristin W Wavell, BS 434-924-6874 kww7d@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Donna L Wolf, PhD    434-982-4206    dlw9t@virginia.edu   
Sub-Investigator: John Kennedy, MD         
Principal Investigator: W. Gerald Teague, MD         
Sub-Investigator: Julia Wisniewsk, MD         
Sub-Investigator: C. Edward Rose, MD         
Sub-Investigator: Mark DeBoer, MD         
Sponsors and Collaborators
University of Virginia
Case Western Reserve University
Investigators
Principal Investigator: W. Gerald Teague, MD University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT01761058     History of Changes
Other Study ID Numbers: 16400, 1U10HL109164-01
Study First Received: January 2, 2013
Last Updated: July 1, 2013
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Virginia:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Disease

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014