N/A
N=26
Evaluating the Asthmatic Response to an Experimental Infection With Rhinovirus in the Atopic
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02111772 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection — 8.72; 2.77 units on a scale — p=0.049
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rhinovirus (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection |
8.72; 2.77 | 0.049 sig |
| SECONDARY Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection Evaluated Without Cough. |
6.09; 0.08 | <0.001 sig |
Summary
In patients with asthma, reactions to allergens in the environment (such as mold, pollen, weed, domestic pets, and dust allergens) play an important role in causing asthma symptoms. However, upper respiratory tract infections, typically those caused by the common cold virus, rhinovirus, can also cause asthma to get worse. In previous studies at the University of Virginia, it was found that mild asthmatics, who had high levels of the allergy antibody (called IgE) in their blood, developed more persistent cold and chest symptoms when they were given an infection with rhinovirus (the most frequent cause of the common cold). The cold symptoms produced by rhinovirus tend to peak during the first 4 -7 days of the cold. These symptoms, including nasal congestion, are similar to what you have experienced with previous colds.
This study is being done to learn how a common cold caused by a viral infection affects people with asthma. The goal is to learn how to improve the care of asthma symptoms caused by the common cold virus (called rhinovirus). Most adults experience one or two colds caused by rhinovirus every year. In addition, 75-80% of asthma exacerbations caused by viral infections are caused by this virus, primarily in children. Adults are less likely to experience significant changes in their asthma symptoms when they get colds, because they have developed protective immune responses from previous colds which help diminish symptoms.
Eligibility Criteria
Inclusion Criteria • ALL SUBJECTS:
- Subjects must be able to understand and provide written informed consent
- Age 18 to 19 at enrollment (See Appendix: Asthma Control Test).
- Short-acting beta-agonist use 70%, or FEV1/FVC ratio > 75% for subjects with FVC values between 80 and 87% predicted whose FEV1 values fall below 70%. a positive methacholine challenge test (i.e. at least a 20% fall in FEV1) at a methacholine concentration of 16 mg/ml or less (15). The methacholine test will not be done if subjects have used albuterol within 4 hours of the test procedure.Evidence for atopy demonstrated during screening (under IRB protocol# 12656) as judged by positive prick skin tests to one or more aero-allergens.
Control subjects. Criteria for inclusion will include those who do not have a history of asthma or allergic disorders (e.g. allergic rhinitis, atopic dermatitis, or food allergies).
Exclusion Criteria ALL SUBJECTS:
- Inability or unwillingness of a participant or subject's legal representative to give written informed consent and HIPPA authorization
- Positive test for serum neutralizing antibody to RV-16. Subjects with a neutralizing antibody titer > 1:4 will be excluded.
- 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
- Who have required nasal or sinus surgery, excluding surgery for a deviated septum within 12 months prior to enrollment.
- 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.
- Absolute neutrophil count (ANC) 4 days during the week before enrollment, or during the week before the inoculation with RV-16.
Control subjects
- Who have a positive methacholine test, or positive prick skin tests at screening under IRB protocol # 12656.
Data sourced from ClinicalTrials.gov (NCT02111772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.