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This study evaluates the performance of ColdZyme® mouth spray on prevention and alleviation of induced rhinovirus upper respiratory tract infection in healthy volunteers. Half of participants will receive ColdZyme® mouth spray while the other half will receive placebo.
Common colds can be caused by a number of viruses, e.g. rhinoviruses, coronaviruses, influenza viruses and others. The majority of colds are however caused by rhinovirus infection, which is responsible for up to 80% of all common colds. This study evaluates the effect of creating a physical barrier on the pharyngeal mucosal membrane to prevent or reduce virus cell entry during common cold infection to reduce total virus load and common cold symptoms in vivo in relation to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ColdZyme | Active Comparator | ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. |
|
| Placebo | Placebo Comparator | Sugar based mouth spray 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 in Viral Load in the URT | Reduction in viral load in the URT(Upper Respiratory Tract), after challenge with rhinovirus, in relation to placebo | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of Symptomatic URTI (Upper Respiratory Tract Infection) | Reduction of number of days having a total symptom severity score of 6 or higher using a 5-graded Jackson scale, in relation to placebo. Will be assessed by the severity of cold symptoms quantified by the modified method of Jackson at peak day (day with highest score). A subject is considered to be a success if the total symptom score is below 6. Otherwise will the subject be classified as a failure to prevent symptomatic URTI. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecilia Ahlström Emanuelsson, MD | Otorhinolaryngology, Skåne University Hospital, Lund. | Principal Investigator |
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| Label | URL |
|---|---|
| Published article: A Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Study on ColdZyme® Mouth Spray against Rhinovirus-Induced Common Cold | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ColdZyme | ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. ColdZyme® mouth spray |
| FG001 | Placebo | Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ColdZyme | ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. ColdZyme® mouth spray |
| BG001 | Placebo | Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction in Viral Load in the URT | Reduction in viral load in the URT(Upper Respiratory Tract), after challenge with rhinovirus, in relation to placebo | Posted | Least Squares Mean | Standard Error | log 10 copies/mL | 7 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ColdZyme | ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. ColdZyme® mouth spray |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysmenorrhoea | Reproductive system and breast disorders |
Due to the small sample size and the low infection rate of 76% and the power calculation being based on an estimated infection rate of >85%, exploratory analyses of subjects who experienced an infection (subjects with a value of viral load above 0 in pharyngeal or nasal sample any time during the study period) were performed. Peak viral load turned out to be an unreliable parameter with sometimes two peaks for the same subject. Thus, viral load as AUC was analyzed in the post hoc analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enzymatica AB | Enzymatica AB | +46 46 286 31 00 | info@enzymatica.com |
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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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|
| 11 days |
| Prevention of Asymptomatic URTI | Asymptomatic URTI will be assessed by quantification of viral load at peak day (day with highest viral load measured by oropharyngeal swab). Will be assessed by quantification of viral load at peak day (day with highest viral load). A subject is considered to be a success if the viral load is not different from the base-line value (from day 0). Otherwise will the subject be classified as a failure to prevent asymptomatic URTI. | 11 days |
| Fewer Days With Symptomatic URTI | The number of days with cold is defined as the sum of all days with a total score of ≥ 6 according to the modified method of Jackson. | 11 days |
| Fewer Days With Asymptomatic URTI | The number of days with asymptomatic URTI is defined as the sum of all days with a viral load significantly different from the baseline. | 11 days |
| Lower Level of Proinflammatory Proteins | Nasal samples will be analysed for the quantity of IL-6 (Interleukin 6), IL-8 and IFNα (Interferon alpha). | 11 days |
| Lower Daily Total Symptom Score | Jackson score was used and the *mean* sum of the score is reported. Jackson score is based on the sum of 5 severity points in the following scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 =very severe), where 0 is minimum and 4 is maximum score, for eight cold symptoms: sneezing, nasal obstruction, nasal discharge, sore throat, cough, headache, chilliness, and malaise. | Day 0-10 |
| Lower Daily Score of Individual Symptoms | Mean (average) value of the participants' score per symptom on day 10 is reported, i.e. per symptom, the total sum of participants self-reported Jackson score from 0 to 4, divided with number of participants on day 10. The Jackson scale for eight cold symptoms is used in the rating, using the following scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 =very severe , where 0 is no symptom and 4 is maximum symptoms (worsed), for eight cold symptoms: sneezing, nasal obstruction, nasal discharge, sore throat, cough, headache, chilliness, and malaise. | Day 10 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Prevention of Symptomatic URTI (Upper Respiratory Tract Infection) | Reduction of number of days having a total symptom severity score of 6 or higher using a 5-graded Jackson scale, in relation to placebo. Will be assessed by the severity of cold symptoms quantified by the modified method of Jackson at peak day (day with highest score). A subject is considered to be a success if the total symptom score is below 6. Otherwise will the subject be classified as a failure to prevent symptomatic URTI. | Posted | Count of Participants | Participants | 11 days |
|
|
|
| Secondary | Prevention of Asymptomatic URTI | Asymptomatic URTI will be assessed by quantification of viral load at peak day (day with highest viral load measured by oropharyngeal swab). Will be assessed by quantification of viral load at peak day (day with highest viral load). A subject is considered to be a success if the viral load is not different from the base-line value (from day 0). Otherwise will the subject be classified as a failure to prevent asymptomatic URTI. | Posted | Count of Participants | Participants | 11 days |
|
|
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| Secondary | Fewer Days With Symptomatic URTI | The number of days with cold is defined as the sum of all days with a total score of ≥ 6 according to the modified method of Jackson. | Posted | Median | Standard Deviation | Days with symptomatic cold | 11 days |
|
|
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| Secondary | Fewer Days With Asymptomatic URTI | The number of days with asymptomatic URTI is defined as the sum of all days with a viral load significantly different from the baseline. | Posted | Mean | Standard Deviation | Days with asymptomatic cold | 11 days |
|
|
|
| Secondary | Lower Level of Proinflammatory Proteins | Nasal samples will be analysed for the quantity of IL-6 (Interleukin 6), IL-8 and IFNα (Interferon alpha). | Posted | Mean | Standard Deviation | pg*day/mL | 11 days |
|
|
|
| Secondary | Lower Daily Total Symptom Score | Jackson score was used and the *mean* sum of the score is reported. Jackson score is based on the sum of 5 severity points in the following scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 =very severe), where 0 is minimum and 4 is maximum score, for eight cold symptoms: sneezing, nasal obstruction, nasal discharge, sore throat, cough, headache, chilliness, and malaise. | Posted | Least Squares Mean | Standard Error | score on a 5 graded scale (0-4) | Day 0-10 |
|
|
|
| Secondary | Lower Daily Score of Individual Symptoms | Mean (average) value of the participants' score per symptom on day 10 is reported, i.e. per symptom, the total sum of participants self-reported Jackson score from 0 to 4, divided with number of participants on day 10. The Jackson scale for eight cold symptoms is used in the rating, using the following scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 =very severe , where 0 is no symptom and 4 is maximum symptoms (worsed), for eight cold symptoms: sneezing, nasal obstruction, nasal discharge, sore throat, cough, headache, chilliness, and malaise. | Posted | Mean | Standard Deviation | score on a scale | Day 10 |
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| Post-Hoc | Area Under the Curve (AUC) for Day 3-10 in the Oropharyngeal Samples of Viral Load | Subjects with no viral load during the study excluded | Posted | Mean | Standard Deviation | copies*day/mL | Day 3, 4, 5, 7, 10 |
|
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|
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| Post-Hoc | Number of Days With Asymptomatic Cold (Oropharyngeal Sample) | Subjects with no viral load during the study excluded | Posted | Median | Standard Deviation | Days with asymptomatic cold | 11 days |
|
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| Post-Hoc | Number of Days With Asymptomatic Cold (Nasal Sample) | Subjects with no viral load during the study excluded | Posted | Mean | Standard Deviation | Days with asymptomatic cold | 11 days |
|
|
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| Post-Hoc | Number of Days With Symptomatic Cold | Subjects with no symptomatic cold during the study excluded | Posted | Median | Standard Deviation | Days with symptomatic cold | 11 days |
|
|
|
| 0 |
| 23 |
| 3 |
| 23 |
| EG001 | Placebo | Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. Placebo | 0 | 23 | 4 | 23 |
| Herpes simplex | Infections and infestations |
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| Urticaria | Skin and subcutaneous tissue disorders |
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| Pyrexia | General disorders |
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| Enlarged uvula | Gastrointestinal disorders |
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| Urinary tract infection | Infections and infestations |
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| Dyspepsia | Gastrointestinal disorders |
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| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| IFNα |
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| Day 2 |
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| Day 3 |
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| Day 4 |
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| Day 5 |
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| Day 6 |
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| Day 7 |
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| Day 8 |
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| Day 9 |
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| Day 10 |
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| Nasal obstruction Day 10 |
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| Sore/scratchy throat Day 10 |
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| Cough Day 10 |
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| Headache Day 10 |
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| Malaise Day 10 |
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| Hoarseness Day 10 |
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| Chilliness Day 10 |
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