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
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Condition or disease |
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Asthma |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
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 |
Study Start Date : | December 2012 |
Estimated Primary Completion Date : | January 2017 |
Estimated Study Completion Date : | May 2017 |
Group/Cohort |
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Severe Asthma
Subjects with Severe Asthma (SARP protocol definition)
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Well controlled asthma
subjects with well controlled asthma
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- Lung Function [ Time Frame: baseline and 3 years ]decline in lung function (FEV1) over 3 years
- 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
Biospecimen Description:

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Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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:
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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.

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): NCT01761058
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT01761058 |
Other Study ID Numbers: |
16400 1U10HL109164-01 ( U.S. NIH Grant/Contract ) |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | July 2, 2013 |
Last Verified: | July 2013 |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Disease |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |