Status:
COMPLETED
A Study to Evaluate the Safety and Use of Human Rhinovirus in Healthy and Asthmatic Participants (MK-0000-218)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
U-BIOPRED Consortium
Conditions:
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2016
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01866306
Start Date
October 22 2013
End Date
January 18 2016
Last Update
September 4 2018
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