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Severe Asthma Research Program - University of Virginia (SARP3)

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ClinicalTrials.gov Identifier: NCT01761058
Recruitment Status : Unknown
Verified July 2013 by University of Virginia.
Recruitment status was:  Recruiting
First Posted : January 4, 2013
Last Update Posted : July 2, 2013
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Case Western Reserve University
Information provided by (Responsible Party):
University of Virginia

Tracking Information
First Submitted Date January 2, 2013
First Posted Date January 4, 2013
Last Update Posted Date July 2, 2013
Study Start Date December 2012
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2013)
Lung Function [ Time Frame: baseline and 3 years ]
decline in lung function (FEV1) over 3 years
Original Primary Outcome Measures
 (submitted: January 2, 2013)
Lung Function [ Time Frame: 3 years ]
decline in lung function (FEV1) over 3 years
Change History
Current Secondary Outcome Measures
 (submitted: July 1, 2013)
  • Asthma Control Questionnaire [ Time Frame: baseline and 3 years ]
    change in score in ACQ. Subjects report having worst asthma symptoms.
  • Puberty Changes [ Time Frame: baseline and 3 years ]
    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 ]
    Exacerbation requiring systemic steroids
Original Secondary Outcome Measures
 (submitted: January 2, 2013)
  • Asthma Control Questionnaire [ Time Frame: 3 years ]
    change in score in ACQ. Subjects report having worst asthma symptoms.
  • Puberty Changes [ Time Frame: 3 years ]
    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 ]
    Exacerbation requiring systemic steroids
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Severe Asthma Research Program - University of Virginia
Official Title The Severe Asthma Research Program at University of Virginia - Airway Redox Biochemistry as a Determinant of Asthma Phenotype During Adolescence
Brief Summary 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Blood: CBC/DIFF, total IgE, Serum, plasma, DNA, RNA, sputum, urine, exhaled breath condensate
Sampling Method Non-Probability Sample
Study Population Children with asthma (severe, well controlled)from the Charlottesville enactment area.
Condition Asthma
Intervention Not Provided
Study Groups/Cohorts
  • Severe Asthma
    Subjects with Severe Asthma (SARP protocol definition)
  • Well controlled asthma
    subjects with well controlled asthma
Publications * Dunican EM, Elicker BM, Gierada DS, Nagle SK, Schiebler ML, Newell JD, Raymond WW, Lachowicz-Scroggins ME, Di Maio S, Hoffman EA, Castro M, Fain SB, Jarjour NN, Israel E, Levy BD, Erzurum SC, Wenzel SE, Meyers DA, Bleecker ER, Phillips BR, Mauger DT, Gordon ED, Woodruff PG, Peters MC, Fahy JV; National Heart Lung and Blood Institute (NHLBI) Severe Asthma Research Program (SARP). Mucus plugs in patients with asthma linked to eosinophilia and airflow obstruction. J Clin Invest. 2018 Mar 1;128(3):997-1009. doi: 10.1172/JCI95693. Epub 2018 Feb 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 2, 2013)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01761058
Other Study ID Numbers 16400
1U10HL109164-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Virginia
Study Sponsor University of Virginia
Collaborators
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Case Western Reserve University
Investigators
Principal Investigator: W. Gerald Teague, MD University of Virginia
PRS Account University of Virginia
Verification Date July 2013