Trial Outcomes & Findings for Clinical Response to Rhinovirus Challenge (NCT NCT02910401)

Last Updated: 2024-01-09

Results Overview

Jackson criteria subjective score for: nasal secretion (0 - none; 1 - mild; 2 - moderate; 3 - severe), congestion (0 - none; 1 - mild; 2 - moderate; 3 - severe), cough (0 - none; 1 - mild; 2 - moderate; 3 - severe), pain/pressure (0 - none; 1 - mild; 2 - moderate; 3 - severe). Scoring was done twice a day and total score reported for a maximum range for each day of 0-24. Scoring was done daily for 4 weeks.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Change in symptom score from day 0 to day 4 after inoculation with the rhinovirus

Results posted on

2024-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Asthmatic Asthmatic subjects will be infected with Rhinovirus (GMP RV16 human (H)RV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only	Allergic Rhinitis Allergic rhinitis subjects will be infected with Rhinovirus (GMP RV16 HRV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only	Healthy Control Healthy controls will be infected with Rhinovirus (GMP RV16 HRV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only
Overall Study STARTED	6	17	15
Overall Study COMPLETED	5	17	13
Overall Study NOT COMPLETED	1	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Asthmatic Asthmatic subjects will be infected with Rhinovirus (GMP RV16 human (H)RV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only	Allergic Rhinitis Allergic rhinitis subjects will be infected with Rhinovirus (GMP RV16 HRV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only	Healthy Control Healthy controls will be infected with Rhinovirus (GMP RV16 HRV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only
Overall Study Study closure Study closure	0	0	2
Overall Study Physician Decision	1	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asthmatic n=6 Participants Asthmatic subjects will be infected with Rhinovirus (GMP RV16 human (H)RV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only	Allergic Rhinitis n=17 Participants Allergic rhinitis subjects will be infected with Rhinovirus (GMP RV16 HRV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only	Healthy Control n=15 Participants Healthy controls will be infected with Rhinovirus (GMP RV16 HRV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=15 Participants	0 Participants n=38 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=6 Participants	17 Participants n=17 Participants	15 Participants n=15 Participants	38 Participants n=38 Participants
Age, Categorical >=65 years	0 Participants n=6 Participants	0 Participants n=17 Participants	0 Participants n=15 Participants	0 Participants n=38 Participants
Age, Continuous	21.7 years STANDARD_DEVIATION 0.5 • n=6 Participants	21.5 years STANDARD_DEVIATION 0.7 • n=17 Participants	22.8 years STANDARD_DEVIATION 0.4 • n=15 Participants	21.9 years STANDARD_DEVIATION 0.4 • n=38 Participants
Sex: Female, Male Female	3 Participants n=6 Participants	10 Participants n=17 Participants	8 Participants n=15 Participants	21 Participants n=38 Participants
Sex: Female, Male Male	3 Participants n=6 Participants	7 Participants n=17 Participants	7 Participants n=15 Participants	17 Participants n=38 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	6 participants n=6 Participants	17 participants n=17 Participants	15 participants n=15 Participants	38 participants n=38 Participants

PRIMARY outcome

Timeframe: Change in symptom score from day 0 to day 4 after inoculation with the rhinovirus

Population: Jackson symptom score

Outcome measures

Outcome measures
Measure	Asthmatic n=5 Participants Asthmatic subjects will be infected with Rhinovirus (GMP RV16 human (H)RV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only	Allergic Rhinitis n=17 Participants Allergic rhinitis subjects will be infected with Rhinovirus (GMP RV16 HRV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only	Healthy Control n=13 Participants Healthy controls will be infected with Rhinovirus (GMP RV16 HRV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only
Change in Symptom Scores Induced by the Rhinovirus Using Jackson Criteria Including Nasal Congestion, Drainage, Cough, Wheezing	5.0 score on a scale Interval 0.0 to 10.0	4.2 score on a scale Interval 0.0 to 10.0	2.8 score on a scale Interval 0.0 to 10.0

Adverse Events

Asthmatic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Allergic Rhinitis

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Healthy Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Asthmatic n=6 participants at risk Asthmatic subjects will be infected with Rhinovirus (GMP RV16 human (H)RV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only	Allergic Rhinitis n=17 participants at risk Allergic rhinitis subjects will be infected with Rhinovirus (GMP RV16 HRV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only	Healthy Control n=15 participants at risk Healthy controls will be infected with Rhinovirus (GMP RV16 HRV-16) Rhinovirus (GMP RV16 HRV-16): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Adverse events were reported for each individual from the time of signing the informed consent form through the end of visit safety visit which was 4 weeks after the viral inoculation (5 weeks after signing consent form). All AEs were recorded on a log for the duration of the study (5 years).	5.9% 1/17 • Adverse events were reported for each individual from the time of signing the informed consent form through the end of visit safety visit which was 4 weeks after the viral inoculation (5 weeks after signing consent form). All AEs were recorded on a log for the duration of the study (5 years).	0.00% 0/15 • Adverse events were reported for each individual from the time of signing the informed consent form through the end of visit safety visit which was 4 weeks after the viral inoculation (5 weeks after signing consent form). All AEs were recorded on a log for the duration of the study (5 years).

Additional Information

Larry Borish, MD

University of Virginia

Phone: 4342436570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place