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This study evaluates the performance of ColdZyme® mouth spray on prevention of common cold symptoms on experimentally induced rhinovirus upper respiratory tract infection in healthy volunteers. Half of participants will receive ColdZyme® mouth spray while the other half will receive placebo.
88 subjects will be inoculated with rhinovirus 16 via the nasal route. The subjects will be randomized 1:1 to ColdZyme® or placebo. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. The subjects will visit the investigational clinic on 6 occasions. During these visits the subjects will leave nasal (lavage) and pharyngeal (swab) samples for quantification of virus replication. All subjects will have a diary for scoring of cold symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ColdZyme | Experimental | ColdZyme® mouth spray liquid. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. |
|
| Placebo | Placebo Comparator | Sugar based mouth spray liquid manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ColdZyme® mouth spray | Device |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of virus load | The primary objective is to investigate the protective effect of ColdZyme® mouth spray against infection in the oropharynx by common cold virus (rhinovirus 16) in vivo in relation to placebo | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce the number of days with common cold symptoms | 11 days | |
| Reduce the number of days with virus present in oropharynx | 11 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Mallia, MD | NHLI, Imperial College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Heart and Lung Institute, Imperial College | London | W2 1PG | United Kingdom |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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|
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |