- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01750411
Severe Asthma Research Program - Wake Forest University (SARP3)
The Severe Asthma Research Program at Wake Forest University - Longitudinal Phenomics and Genetics of Severe Asthma.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
-
-
North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The target recruitment goal for each center is 75% adults (age 18 and older) and 25% children age 6-17 years. Within the pediatric age group, an attempt will be made to enroll equal numbers of children 6-11 and 12-17 years of age. Similarly, an attempt will be made to enroll at least 50% females and 30% minorities.
Given the mission of SARP, a diverse sample of subjects with asthma is needed to gain better understanding of asthma and its endotypes. Because there are a number of respiratory disorders that may be confused with asthma or confound asthma assessment, SARP enrollees must meet the all following eligibility criteria as outlined below:
Description
Inclusion Criteria:
- Physician diagnosis of asthma,
- Age 6 years and older
Evidence of historical reversibility, including either:
- FEV1 bronchodilator reversibility ≥ 12%, or
- Airway hyperresponsiveness reflected by methacholine PC20≤16 mg/mL.
Exclusion Criteria:
- No primary medical caregiver
- Pregnancy (only 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
- Planning to relocate from the clinical center area before study completion
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Asthma
Severe Asthma Not severe Asthma
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pulmonary function over time
Time Frame: 36 months
|
Pulmonary function test results include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of severe asthma exacerbations
Time Frame: 36 months
|
Frequency of severe asthma exacerbations
|
36 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eugene R Bleecker, MD, University of Arizona Department of Medicine
- Principal Investigator: Deborah A Meyers, PhD, University of Arizona Department of Medicine
- Principal Investigator: Wendy C Moore, MD, Wake Forest University Health Sciences
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00021507
- 1U10HL109164-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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