CompletedNot Applicable

Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold

46 participantsStarted 2013-03

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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.

What they're measuring

Reduction in Viral Load in the URT

Timeframe: 7 days

Trial details

NCT IDNCT02522949

SponsorEnzymatica AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-06

Results submitted2022-01-18

View on ClinicalTrials.gov More Common Cold trials