Recruitment

Recruitment Status
Completed
Estimated Enrollment
24

Inclusion Criteria

Age 18 to < 40 years of age, any gender, any racial/ethnic origin.
Subjects must be able to understand and provide written informed consent
Participant must be willing to comply with study procedures and requirements. Participant must be considered eligible for participation based on results of screening procedures conducted by protocol number 20100686 at VCU and IRB# 12656 at UVA.
Age 18 to < 40 years of age, any gender, any racial/ethnic origin.
Subjects must be able to understand and provide written informed consent
Participant must be willing to comply with study procedures and requirements. Participant must be considered eligible for participation based on results of screening procedures conducted by protocol number 20100686 at VCU and IRB# 12656 at UVA.

Exclusion Criteria

Absolute neutrophil count (ANC) < 1800 cells/mm3 (or 1.8 K/uL) detected during screening within 6 weeks of enrollment.
Inability or unwillingness of a participant or subject's legal representative to give written informed consent and HIPPA authorization
Who have required nasal or sinus surgery, excluding surgery for a deviated septum within 12 months prior to enrollment.
...
Absolute neutrophil count (ANC) < 1800 cells/mm3 (or 1.8 K/uL) detected during screening within 6 weeks of enrollment.
Inability or unwillingness of a participant or subject's legal representative to give written informed consent and HIPPA authorization
Who have required nasal or sinus surgery, excluding surgery for a deviated septum within 12 months prior to enrollment.
Positive test for serum neutralizing antibody to RV-16. Subjects with a neutralizing antibody titer > 1:4 will be excluded.
Who have a 5 pack/year history of smoking, or any smoking within the last 6 months.
Female subjects who are or who plan to become pregnant during the study, or who are nursing a baby. Additionally, to be included in this study, a woman of child-bearing potential must have a negative urine pregnancy test at screening, during the run-in, and prior to viral inoculation and agree to use an effective method of birth control such as, but not limited to, birth control pills, contraceptive foam, diaphragm, IUD, abstinence, or condoms.
Chronic heart disease, lung diseases other than asthma, or other chronic illnesses, including primary and/or secondary immunodeficiency.
An upper or lower respiratory tract infection within six weeks prior to enrollment

Summary

Conditions
Asthma
Type
Interventional
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 40 years
Gender
Both males and females

Description

Using rhinovirus strain 16 (RV-16) for inoculation, this study is designed to examine mechanisms of the asthmatic response to RV in the atopic host. In keeping with this, the primary objective of this investigation will be to test the hypothesis that mild asthmatics enrolled in this study will exper...

Using rhinovirus strain 16 (RV-16) for inoculation, this study is designed to examine mechanisms of the asthmatic response to RV in the atopic host. In keeping with this, the primary objective of this investigation will be to test the hypothesis that mild asthmatics enrolled in this study will experience significantly increased lower respiratory tract symptoms over the first 4 days after experimental inoculation with RV-16 than non-allergic, non-asthmatic controls (as shown in our previous studies). It is anticipated that the results will serve to guide the development of new treatments to prevent asthma attacks provoked by RV. This will be a 5 week longitudinal study of 18 young allergic adults with mild asthma and 18 non-asthmatic controls who will be evaluated for 1 week to establish baseline symptoms and lung function, followed by an inoculation with rhinovirus (strain-16) and subsequent clinical and laboratory (mechanistic) monitoring for an additional 4 weeks. To participate in this study, subjects must live within 90 minutes by car from the University of Virginia. Note: This study has been reviewed and is being monitored for safety by the NIH/NIAID Safety Monitoring Committee and by teh University of Virginia IRB (#12673). The virus pool used for inoculation has been produced under GMP conditions and is approved for this research by the FDA.

Inclusion Criteria

Age 18 to < 40 years of age, any gender, any racial/ethnic origin.
Subjects must be able to understand and provide written informed consent
Participant must be willing to comply with study procedures and requirements. Participant must be considered eligible for participation based on results of screening procedures conducted by protocol number 20100686 at VCU and IRB# 12656 at UVA.
Age 18 to < 40 years of age, any gender, any racial/ethnic origin.
Subjects must be able to understand and provide written informed consent
Participant must be willing to comply with study procedures and requirements. Participant must be considered eligible for participation based on results of screening procedures conducted by protocol number 20100686 at VCU and IRB# 12656 at UVA.

Exclusion Criteria

Absolute neutrophil count (ANC) < 1800 cells/mm3 (or 1.8 K/uL) detected during screening within 6 weeks of enrollment.
Inability or unwillingness of a participant or subject's legal representative to give written informed consent and HIPPA authorization
Who have required nasal or sinus surgery, excluding surgery for a deviated septum within 12 months prior to enrollment.
...
Absolute neutrophil count (ANC) < 1800 cells/mm3 (or 1.8 K/uL) detected during screening within 6 weeks of enrollment.
Inability or unwillingness of a participant or subject's legal representative to give written informed consent and HIPPA authorization
Who have required nasal or sinus surgery, excluding surgery for a deviated septum within 12 months prior to enrollment.
Positive test for serum neutralizing antibody to RV-16. Subjects with a neutralizing antibody titer > 1:4 will be excluded.
Who have a 5 pack/year history of smoking, or any smoking within the last 6 months.
Female subjects who are or who plan to become pregnant during the study, or who are nursing a baby. Additionally, to be included in this study, a woman of child-bearing potential must have a negative urine pregnancy test at screening, during the run-in, and prior to viral inoculation and agree to use an effective method of birth control such as, but not limited to, birth control pills, contraceptive foam, diaphragm, IUD, abstinence, or condoms.
Chronic heart disease, lung diseases other than asthma, or other chronic illnesses, including primary and/or secondary immunodeficiency.
An upper or lower respiratory tract infection within six weeks prior to enrollment

Tracking Information

NCT #
NCT02111772
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
  • Principal Investigator: Heymann W Peter, MD University of Virginia
  • Heymann W Peter, MD University of Virginia
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