University of Wisconsin Severe Asthma Research Program III
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ClinicalTrials.gov Identifier: NCT01760915 |
Recruitment Status :
Suspended
(Due to COVID-19)
First Posted : January 4, 2013
Last Update Posted : April 3, 2020
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Condition or disease | Intervention/treatment |
---|---|
Asthma | Other: NC100182 Hyperpolarized 3He |
Study Type : | Observational |
Estimated Enrollment : | 120 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Severe Asthma Research Program (SARP) - University of Wisconsin |
Actual Study Start Date : | November 28, 2012 |
Estimated Primary Completion Date : | February 2021 |
Estimated Study Completion Date : | February 2021 |
Group/Cohort | Intervention/treatment |
---|---|
Severe asthma
Subjects with severe asthma (SARP protocol definition)
|
Other: NC100182 Hyperpolarized 3He
Magnetic Resonance Imaging (MRI) will take place and include inhalation of hyperpolarized helium to construct an image of the lungs.
Other Name: helium |
Well controlled asthma
Subjects with well controlled asthma
|
Other: NC100182 Hyperpolarized 3He
Magnetic Resonance Imaging (MRI) will take place and include inhalation of hyperpolarized helium to construct an image of the lungs.
Other Name: helium |
Normal control
Subjects that are healthy normals
|
Other: NC100182 Hyperpolarized 3He
Magnetic Resonance Imaging (MRI) will take place and include inhalation of hyperpolarized helium to construct an image of the lungs.
Other Name: helium |
- Lung function [ Time Frame: Baseline versus 3 years ]Changes in airway function after a severe exacerbation, and longitudinally over 3 years, as measured by lung function.
- Plethysmographic lung volumes [ Time Frame: Baseline versus 3 years ]Changes in airway function after a severe exacerbation, and longitudinally over 3 years, as measured by Plethysmographic lung volumes.
- Hyperpolarized gas magnetic resonance imaging [ Time Frame: Baseline versus 3 years ]Changes in airway function after a severe exacerbation, and longitudinally over 3 years, as measured by Hyperpolarized gas magnetic resonance imaging.
- Multidetector computed tomography imaging [ Time Frame: Baseline versus 3 years ]Changes in airway function after a severe exacerbation, and longitudinally over 3 years, as measured by Multidetector computed tomography imaging (adults only).
- Exacerbations [ Time Frame: Baseline versus 3 years ]Exacerbation requiring systemic steroids
- Plasma levels of biomarkers [ Time Frame: Baseline versus 3 years ]Changes in airway function after a severe exacerbation, and longitudinally over 3 years, as measured by plasma levels of biomarkers.
- Induced sputum mediators [ Time Frame: Baseline versus 3 years ]Changes in airway function after a severe exacerbation, and longitudinally over 3 years, as measured by induced sputum mediators.
- Nasal washing samples for virology [ Time Frame: Baseline versus 3 years ]Changes in airway function after a severe exacerbation, and longitudinally over 3 years, as measured by nasal washing samples for virology.
- Bronchoscopy samples for virology, inflammatory cells and mediators [ Time Frame: Baseline versus 3 years ]Changes in airway function after a severe exacerbation, and longitudinally over 3 years, as measured by bronchoscopy samples for virology, inflammatory cells and mediators (adults only).
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Physician diagnosis of asthma
- Age 6 years and older
- Evidence of historical reversibility, including either:
1. FEV1 bronchodilator reversibility ≥ 12%, or
2. Airway hyperresponsiveness reflected by a methacholine PC20 ≤16 mg/mL.
Exclusion Criteria:
- No primary medical caregiver,
- Pregnancy (if undergoing methacholine challenge or bronchoscopy),
- 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 asthma symptoms, 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,
- 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, or
- 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.

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): NCT01760915
United States, Wisconsin | |
UW Madison | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Nizar N Jarjour, MD | UW Madison |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT01760915 |
Other Study ID Numbers: |
2012-0571 4U10HL109168 ( U.S. NIH Grant/Contract ) A534285 ( Other Identifier: UW, Madison ) SMPH/MEDICINE/PULMON MED ( Other Identifier: UW, Madison ) |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | April 3, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
asthma severe |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |