Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold

Enzymatica

Status: Completed

Conditions: Common Cold

Treatments: Device: ColdZyme Placebo; Device: ColdZyme

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT03794804

008618

Details and patient eligibility

About

This study evaluates the impact of ColdZyme® Mouth Spray on quality of life during common cold. Half of the participants will receive ColdZyme® Mouth Spray, half will receive a placebo device.

Enrollment: 701 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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, including in particular:

   • Use of IP as recommended
   • Filling in diary
   • Keeping habitual life-style, including diet and physical activity level
   • No use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/anti-rheumatics, anti-phlogistics, anti-tussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) during the study (except for the defined "rescue" treatment)

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,

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
   • Asthma, chronic obstructive lung disease or any other acute/chronic airways disease/disorder (e.g. 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/anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) within the last 4 weeks prior to V1

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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701 participants in 2 patient groups, including a placebo group

ColdZyme

Active Comparator group

Description:

ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion. The IP use should start when following conditions have been fulfilled: * Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND * A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total.

Treatment:

Device: ColdZyme

Placebo

Placebo Comparator group

Description:

Water based mouth spray manufactured to be similar to ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion. The IP use should start when following conditions have been fulfilled: * Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND * A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total.

Treatment:

Device: ColdZyme Placebo