N/A
N=46
Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold
Common Cold
Bottom Line
View on ClinicalTrials.gov: NCT02522949 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Reduction in Viral Load in the URT — 3.6; 3.3; 4.9; 4.1 log 10 copies/mL — p=0.7146
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ColdZyme® mouth spray (Device); Placebo (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Enzymatica AB
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Viral Load in the URT |
3.6; 3.3; 4.9; 4.1 | 0.7146 |
| SECONDARY Prevention of Symptomatic URTI (Upper Respiratory Tract Infection) |
21; 16; 2; 7 | — |
| SECONDARY Prevention of Asymptomatic URTI |
18; 15; 5; 8 | — |
| SECONDARY Fewer Days With Symptomatic URTI |
2.0; 3.0 | — |
| SECONDARY Fewer Days With Asymptomatic URTI |
1.0; 1.4 | — |
| SECONDARY Lower Level of Proinflammatory Proteins |
273.93; 254.45; 1863.36; 2057.59; 101.24; 101.15 | — |
| SECONDARY Lower Daily Total Symptom Score |
0.9; 0.2; 1.5; 1.4; 4.0; 4.3 | — |
| SECONDARY Lower Daily Score of Individual Symptoms |
0.22; 0.17; 0.52; 0.57; 0.39; 0.52 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Healthy male or female subjects between 18-65 years. The investigator judges the definition of healthy by detailed medical history and physical examination.
- Females of childbearing potential: should use reliable method of birth control. Reliable methods are hormonal contraceptives (combination pills, injections or implants), intrauterine device, condom or declared absence of sexual contact. Post-menopausal woman is defined as absence of menstrual discharge for at least two years.
- Signed informed consent form prior to any study-related procedures.
- Willingness and ability to complete the study.
- Perceived to have had at least one cold per year.
Exclusion Criteria
- Smoker, during the last 12 months.
- Any cold symptom within the last month such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough.
- Presence of serum neutralising antibodies against human rhinovirus16 at screening.
- Active allergic rhinitis, asthma or chronic obstructive pulmonary disease in last year.
- Positive for fur allergy (if subject is likely to come in contact with the specific pet) and/or dust-mite allergy in skin prick test at screening.
- Nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
- Females: Pregnant, breast-feeding or intentions to become pregnant during the study.
- Active autoimmune disease in last year.
- Evidence or history of drug or alcohol abuse.
- Use of any prescribed or non-prescribed medication (except for contraceptives, paracetamol and ibuprofen) within 2 weeks prior to the first administration of investigational product until the end of study.
- Use of any over the counter cold prophylaxis products such as C-vitamins, zinc or Echinacea within 1 month prior to the first administration of investigational product until the end of study.
- Participation in other clinical study within 60 days
Data sourced from ClinicalTrials.gov (NCT02522949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.