A Study to Evaluate the Safety and Use of Human Rhinovirus in Healthy and Asthmatic Participants (MK-0000-218)
Condition: Asthma
MeSH terms: Asthma
Intervention: RV16UB; LABA
Intervention description: RV16UB is administered by spraying an atomized viral suspension into a single nostril. Planned doses of RV16UB in Part 1 are 10 Tissue Culture Infective Dose 50 (TCID50), 100 TCID50, 1000 TCID50 and 10,000 TCID50.; Asthmatic participants were treated with LABA as part of their standard of care
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to establish the safety and tolerability of Unbiased Biomarkers
      for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) human rhinovirus 16 (RV16UB)
      in healthy and asthmatic participants, and to identify an appropriate dosage of RV16UB in
      order to study biomarkers in asthmatic participants. The study is divided into 2 parts. Part
      1 is a dose-finding study where healthy participants, and asthmatic participants, who were
      either treated or not treated with a class of long-acting beta antagonists (LABA) will be
      recruited to undergo nasal challenge with increasing doses of RV16UB. Part 2 is a biomarker
      study where mild to moderate asthmatics undergo challenge with the most appropriate dose of
      RV16UB identified in Part 1, based on tolerability and viral effects. .
    

Eligibility criteria:

        Inclusion Criteria:

        Parts 1 and 2:

          -  have a Body Mass Index (BMI) between =< 35 kg/m^2 and > 17 kg/m^2

          -  female of childbearing potential is not pregnant and agrees to use 2 acceptable
             methods of birth control until 10 days after the last visit,; or female is of
             non-childbearing potential

          -  is a non-smoker, or has not smoked within prior 12 months, with a history of =< 10
             pack-years

        Part 1:

        Either of the following:

          -  healthy (may have out-of season seasonal allergies)

          -  mild to moderate-asthmatic with a history of spontaneous or exertional wheezing; and
             with all of the following for > 4 weeks prior: daytime symptoms twice weekly or less,
             no activity limitation, no nocturnal symptoms, uses reliever treatment twice daily or
             less, with an unchanged asthma medication dose, and uses inhaled corticosteroid (ICS)
             at a stable dose-equivalent of =< 500 mcg/day fluticasone propionate

        Part 2:

          -  mild to moderate-asthmatics only with a history of spontaneous or exertional wheezing;
             and with all of the following for > 4 weeks prior: daytime symptoms twice weekly or
             less, no activity limitation, no nocturnal symptoms, uses reliever treatment twice
             daily or less, with an unchanged asthma medication dose, and uses ICS at a stable
             dose-equivalent of =< 500 mcg/day fluticasone propionate

          -  had a mild change in symptoms associated with viral syndrome, leading to temporarily
             increased short acting beta agonist use or increased ICS dose within the past 5 years

        Exclusion Criteria:

          -  has a history of severe or difficult to manage allergies (e.g. food, drug, latex)

          -  has a history of asthma-related ventilatory failure in adolescence or adulthood

          -  is positive for hepatitis B surface antigen, hepatitis C antibodies or human
             immunodeficiency virus (HIV)

          -  has significant nasal septum deviation, nasal polyps or other nasal anatomical
             abnormality

          -  shares the same household or has intimate contact with an infant, pregnant or
             lactating woman, or immunosuppressed individual

          -  has a history or current evidence of any upper or lower respiratory tract infection
             within 6 weeks prior to baseline assessment

          -  had major surgery or lost 1 unit (500 mL) of blood within prior 4 weeks

          -  has participated in another investigational trial within the prior 10 weeks

          -  is pregnant or a nursing mother

          -  uses excluded prescription or non-prescription medications within 2 weeks prior to
             initial viral challenge and throughout the trial