Clinical trial NCT03831763: Evaluation of the Use of Various Assessments of Common Cold Symptoms for Proof of Efficacy of ColdZyme Mouth Spray
Official title: Single (Investigator)-Blind, Randomized, Parallel-group Study to Evaluate the Use of Various Assessments of Common Cold Symptoms for Proof of Efficacy of CMS016317
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Cold
Lead sponsor: Enzymatica AB
Sponsor class: INDUSTRY
Collaborators: name: Analyze & Realize
First posted: 2019-02-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ColdZyme® Mouth Spray while the other half may use optional care as needed.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in the Jackson scale between the study groups
timeFrame: 16+/-4 days from start of common cold symptoms
measure: Difference in WURSS-21 Quality of Life sub score between the study groups
timeFrame: 16+/-4 days from start of common cold symptoms
measure: Difference in the Sore Throat Scale between the study groups
timeFrame: 16+/-4 days from start of common cold symptoms
measure: Difference in the Irritated Throat Scale between the study groups
timeFrame: 16+/-4 days from start of common cold symptoms
measure: Percentage of subjects with prevention of cold outburst
timeFrame: Within 3 days from symptom start
measure: Difference in number of findings during physical examination compared between the study groups
timeFrame: From randomisation through study completion, maximum 16 weeks
measure: Blood pressure (mmHg) compared between the study groups
timeFrame: From randomisation through study completion, maximum 16 weeks
measure: Pulse rate (bpm) compared between the study groups
timeFrame: From randomisation through study completion, maximum 16 weeks
measure: Number of subjects with adverse events
timeFrame: From randomisation through study completion, maximum 16 weeks
measure: Number of device deficiencies
timeFrame: During IP use, maximum 12 days from symptom start
Secondary outcomes:
Other outcomes:
measure: Duration of common cold symptoms
timeFrame: 16+/-4 days from start of common cold symptoms
measure: Use of concomitant treatment/remedies
timeFrame: 16+/-4 days from start of common cold symptoms
measure: Global evaluation of efficacy by subjects at study end
timeFrame: 16+/-4 days from start of common cold symptoms
Locations:
city: Berlin
country: Germany
facility: analyze & realize GmbH
city: Berlin
country: Germany
facility: Barbara Grube
city: Berlin
country: Germany
facility: Dr. med. Petra Sandow and Eugenia Fischkina
city: Berlin
country: Germany
facility: Dr. med. Ruhland
city: Berlin
country: Germany
facility: Klinische Forschung Berlin
city: Berlin
country: Germany
facility: POLIKUM Institut GmbH
city: Berlin
country: Germany
facility: Thomas Wünsche
Study officials:
affiliation: analyze & realize GmbH
name: Ralf Uebelhack, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: