Status:
COMPLETED
Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold
Lead Sponsor:
Enzymatica AB
Collaborating Sponsors:
Analyze & Realize
Conditions:
Common Cold
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- Men and women
- Age 18 to 70 years old
- 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
- 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)
- 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
- Known allergy or hypersensitivity to the components of the investigational product
- 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
- Influenza vaccination within the last 3 months prior to V1 and during the study
- 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
- Pregnancy or nursing
- History of (in the past 12 months prior to V1) or current abuse of drugs, alcohol or medication
- Participation in the present study of a person living in the same household as the subject
- Inability to comply with study requirements according to investigator's judgement
- Participation in another clinical study in the 30 days prior to V1 and during the study
Key Trial Info
Start Date :
January 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2019
Estimated Enrollment :
701 Patients enrolled
Trial Details
Trial ID
NCT03794804
Start Date
January 28 2019
End Date
June 26 2019
Last Update
August 22 2019
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
analyze & realize GmbH
Berlin, Germany
2
emovis GmbH
Berlin, Germany
3
Klinische Forschung Berlin-Mitte GmbH
Berlin, Germany
4
Klinische Forschung Berlin
Berlin, Germany