A Study to Evaluate the Safety and Use of Human Rhinovirus in Healthy and Asthmatic Participants (MK-0000-218)

NCT ID: NCT01866306

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-22
• Study Completion Date: 2016-01-18

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 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. .

Conditions

Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy 10 TCID50 (Part 1)

Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.

Group Type: EXPERIMENTAL

RV16UB

Intervention Type: BIOLOGICAL

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.

Healthy 100 TCID50 (Part 1)

Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.

Group Type: EXPERIMENTAL

RV16UB

Intervention Type: BIOLOGICAL

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.

Healthy 1000 TCID50 (Part 1)

Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.

Group Type: EXPERIMENTAL

RV16UB

Intervention Type: BIOLOGICAL

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 non-LABA 10 TCID50 (Part 1)

Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.

Group Type: EXPERIMENTAL

RV16UB

Intervention Type: BIOLOGICAL

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 non-LABA 100 TCID50 (Part 1)

Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.

Group Type: EXPERIMENTAL

RV16UB

Intervention Type: BIOLOGICAL

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 LABA 100 TCID50 (Part 1)

Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.

Group Type: EXPERIMENTAL

RV16UB

Intervention Type: BIOLOGICAL

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.

LABA

Intervention Type: DRUG

Asthmatic participants were treated with LABA as part of their standard of care

Asthmatic non-LABA 100 TCID50 (Part 2)

Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.

Group Type: EXPERIMENTAL

RV16UB

Intervention Type: BIOLOGICAL

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.

Interventions

RV16UB

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.

Intervention Type: BIOLOGICAL

LABA

Asthmatic participants were treated with LABA as part of their standard of care

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U-BIOPRED Consortium

UNKNOWN

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2013-000618-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0000-218

Identifier Type: -

Identifier Source: org_study_id