Evaluation of the Use of Various Assessments of Common Cold Symptoms for Proof of Efficacy of ColdZyme Mouth Spray

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-25

Study Completion Date

2018-06-05

Brief Summary

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This study evaluates the use of various assessments of common cold symptoms for proof of efficacy of ColdZyme Mouth Spray on naturally acquired common colds. Half of the participants will receive ColdZyme® Mouth Spray while the other half may use optional care as needed.

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Detailed Description

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Conditions

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Common Cold

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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ColdZyme

Group Type ACTIVE_COMPARATOR

ColdZyme

Intervention Type DEVICE

ColdZyme® Mouth Spray is a CE-marked medical device with the following composition: glycerol, water, cod trypsin, ethanol (\<1 %), calcium chloride, trometamol and menthol.

ColdZyme® Mouth Spray consists of a 20 ml bottle, pump, spray nozzle and protective cap.

Optional care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ColdZyme

ColdZyme® Mouth Spray is a CE-marked medical device with the following composition: glycerol, water, cod trypsin, ethanol (\<1 %), calcium chloride, trometamol and menthol.

ColdZyme® Mouth Spray consists of a 20 ml bottle, pump, spray nozzle and protective cap.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Men and women
2. Age 18 to 70 years old
3. Increased risk for common cold (at least 3 self-reported occurences of common cold within the last 12 months prior to V1) but generally in good health
4. Readiness to comply with trial procedures:

* Use of IP as recommended (verum group)
* Filling in diary
* Keeping habitual diet and physical activity level
5. Women of child-bearing potential:

* Have to agree to use appropriate contraception methods
* Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1

Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.

Exclusion Criteria

1. Known allergy or hypersensitivity to the components of the investigational product
2. History and/or presence of clinically significant condition/ disorder (self-reported), which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:

* Nasal disorder (e.g. polyposis, relevant septal deviation, ulcer etc.) and/or reconstructive surgery
* Acute/chronic airways disease/disorder (e.g. chronic obstructive lung disease, asthma, chronic cough of any origin)
* Acute psychiatric disorders
* Any other acute/chronic serious organ or systemic diseases
3. Influenza vaccination within the last 3 months prior to V1 and during the study
4. Regular use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/antirheumatics, anti-phlogistics, antitussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) within the last 4 weeks prior to V1 and during the study (except for the defined optional care)
5. Pregnancy or nursing
6. History of (in the past 12 months prior to V1) or current abuse of drugs, alcohol or medication
7. Participation in the present study of a person living in the same household as the subject
8. Inability to comply with study requirements according to investigator's judgement
9. Participation in another clinical study in the 30 days prior to V1 and during the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes