Trial Outcomes & Findings for Evaluating the Asthmatic Response to an Experimental Infection With Rhinovirus in the Atopic (NCT NCT02111772)

Last Updated: 2018-07-09

Results Overview

The primary endpoint will be based on the comparison of cumulative lower respiratory tract symptom scores (CLRTS) in the asthmatic subjects compared to the non-asthmatic subjects over the first 4 days of acute infection. The symptoms evaluated daily included wheeze, chest tightness, shortness of breath, and cough. Symptom scores, including wheeze, shortness of breath, and chest discomfort were recorded by subjects twice daily. Each symptom was scored on a scale of 1-3. Therefore, the total maximum (worst) score for a day would be 24. The scores recorded daily could range from 0 to 24.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

4 days

Results posted on

2018-07-09

Participant Flow

Participant milestones

Participant milestones
Measure	Asthmatic Subjects Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus. Rhinovirus	Without Asthma Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus Rhinovirus
Overall Study STARTED	12	14
Overall Study COMPLETED	12	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Asthmatic Response to an Experimental Infection With Rhinovirus in the Atopic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asthmatic Subjects n=12 Participants Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus. Rhinovirus	Without Asthma n=14 Participants Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus Rhinovirus	Total n=26 Participants Total of all reporting groups
Age, Continuous	24.1 years n=99 Participants	21.9 years n=107 Participants	22.9 years n=206 Participants
Sex: Female, Male Female	9 Participants n=99 Participants	10 Participants n=107 Participants	19 Participants n=206 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	4 Participants n=107 Participants	7 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=99 Participants	14 Participants n=107 Participants	26 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) White	10 Participants n=99 Participants	14 Participants n=107 Participants	24 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Total IgE level	1239 International Units/ml n=99 Participants	14 International Units/ml n=107 Participants	110 International Units/ml n=206 Participants
Negative serum antibody to Rhinovirus-16	12 Participants n=99 Participants	14 Participants n=107 Participants	26 Participants n=206 Participants

PRIMARY outcome

Timeframe: 4 days

Population: One asthmatic subject completed the study, but was dropped according to protocol because that subject acquired a cold after enrollment, but before rhinovirus inoculation. One subject without asthma was dropped according to protocol, because they did not develop a cold after inoculation with rhinovirus.

Outcome measures

Outcome measures
Measure	Asthmatic Subjects n=11 Participants Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus. Rhinovirus	Without Asthma n=13 Participants Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus Rhinovirus
Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection	8.72 units on a scale Interval 1.55 to 15.91	2.77 units on a scale Interval 0.22 to 5.32

SECONDARY outcome

Timeframe: 4 days

Symptom scores, including wheeze, shortness of breath, and chest discomfort were recorded by subjects twice daily. Each symptom was scored on a scale of 1-3. Therefore, the total maximum (worst) score for a day would be 18. The scores recorded daily could range from 0 to 18.

Outcome measures

Outcome measures
Measure	Asthmatic Subjects n=11 Participants Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus. Rhinovirus	Without Asthma n=13 Participants Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus Rhinovirus
Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection Evaluated Without Cough.	6.09 units on a scale Interval 0.47 to 11.71	0.08 units on a scale Interval 0.0 to 0.24

Adverse Events

Asthmatic Subjects

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Without Asthma

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Asthmatic Subjects n=12 participants at risk Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus. Rhinovirus	Without Asthma n=14 participants at risk Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus Rhinovirus
Blood and lymphatic system disorders Neutropenia	0.00% 0/12 • 5 years Collection of adverse events is described in our protocol reviewed and approved by our IRB and the NIH.	7.1% 1/14 • Number of events 2 • 5 years Collection of adverse events is described in our protocol reviewed and approved by our IRB and the NIH.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	8.3% 1/12 • Number of events 1 • 5 years Collection of adverse events is described in our protocol reviewed and approved by our IRB and the NIH.	0.00% 0/14 • 5 years Collection of adverse events is described in our protocol reviewed and approved by our IRB and the NIH.
Gastrointestinal disorders Upset stomach	8.3% 1/12 • Number of events 1 • 5 years Collection of adverse events is described in our protocol reviewed and approved by our IRB and the NIH.	0.00% 0/14 • 5 years Collection of adverse events is described in our protocol reviewed and approved by our IRB and the NIH.

Additional Information

Dr. Peter W. Heymann

University of Virginia

Phone: 434-242-8209

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place