Clinical trial NCT02522949: Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold
Official title: Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Induced Rhinovirus Upper Respiratory Tract Infection in Healthy Volunteers. A Double-blind, Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Cold
Lead sponsor: Enzymatica AB
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy male or female subjects between 18-65 years. The investigator judges the definition of healthy by detailed medical history and physical examination.
2. 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.
3. Signed informed consent form prior to any study-related procedures.
4. Willingness and ability to complete the study.
5. Perceived to have had at least one cold per year.

Exclusion Criteria:

1. Smoker, during the last 12 months.
2. Any cold symptom within the last month such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough.
3. Presence of serum neutralising antibodies against human rhinovirus16 at screening.
4. Active allergic rhinitis, asthma or chronic obstructive pulmonary disease in last year.
5. 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.
6. Nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
7. Females: Pregnant, breast-feeding or intentions to become pregnant during the study.
8. Active autoimmune disease in last year.
9. Evidence or history of drug or alcohol abuse.
10. 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.
11. 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.
12. Participation in other clinical study within 60 days

Primary outcomes:
measure: Reduction in Viral Load in the URT
timeFrame: 7 days
Secondary outcomes:
measure: Prevention of Symptomatic URTI (Upper Respiratory Tract Infection)
timeFrame: 11 days
measure: Prevention of Asymptomatic URTI
timeFrame: 11 days
measure: Fewer Days With Symptomatic URTI
timeFrame: 11 days
measure: Fewer Days With Asymptomatic URTI
timeFrame: 11 days
measure: Lower Level of Proinflammatory Proteins
timeFrame: 11 days
measure: Lower Daily Total Symptom Score
timeFrame: Day 0-10
measure: Lower Daily Score of Individual Symptoms
timeFrame: Day 10
Other outcomes:
Locations:
Study officials:
affiliation: Otorhinolaryngology, Skåne University Hospital, Lund.
name: Cecilia Ahlström Emanuelsson, MD
role: PRINCIPAL_INVESTIGATOR
References: