Status:
COMPLETED
Evaluation of the Use of Various Assessments of Common Cold Symptoms for Proof of Efficacy of ColdZyme Mouth Spray
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 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 Cold...
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:
- Use of IP as recommended (verum group)
- Filling in diary
- Keeping habitual diet and physical activity level
- 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
- 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
- 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
- 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/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)
- 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 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2018
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03831763
Start Date
January 25 2018
End Date
June 5 2018
Last Update
August 21 2019
Active Locations (7)
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1
analyze & realize GmbH
Berlin, Germany
2
Barbara Grube
Berlin, Germany
3
Dr. med. Petra Sandow and Eugenia Fischkina
Berlin, Germany
4
Dr. med. Ruhland
Berlin, Germany