Severe Asthma Research Program - University of Virginia (SARP3)
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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 |
- Lung Function [ Time Frame: 3 years ] [ Designated as safety issue: No ]decline in lung function (FEV1) over 3 years
- Asthma Control Questionnaire [ Time Frame: 3 years ] [ Designated as safety issue: No ]change in score in ACQ. Subjects report having worst asthma symptoms.
- Puberty Changes [ Time Frame: 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: 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, we 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, we propose to study a new component that is informative for longitudinal assessment of severe asthma phenotypes: gender effects. We 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 |
Children with asthma (severe, well controlled)from the Charlottesville enactment area.
Inclusion Criteria:
Physician diagnosis of asthma
• Age 6 years to 17 years old Evidence of historical reversibility, including either;
- FEV1 bronchodilator reversibility greater than or equal to 12%, or
- Airway hyperresponsivesness reflected by a methacholine PC20 less than or equal to 16 mg/ml.
Exclusion Criteria:
Exclusion criteria include any of the following:
- Pregnancy during the characterization phase*,
- 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 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,
- History of premature birth before 35 weeks gestation,
- Unwillingness to receive an intramuscular triamcinolone acetonide injection.
- Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures,
- Planning to relocate from the clinical center area before study completion,
- 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
- Currently participating in an investigational drug trial.
Contacts and Locations| Contact: Donna L Wolf, PhD | 434-982-4206 | dlw9t@virginia.edu |
| Contact: Kristin W Wavell, BS | 434-924-6874 | kww7d@virginia.edu |
| 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 | |
| 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: | January 2, 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 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