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

Common Cold Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831763
• Other study ID #: 016317
• Status: Completed
• Phase: N/A
• Start date: January 25, 2018
• Est. completion date: June 5, 2018

Study information

• Verified date: August 2019
• Source: Enzymatica AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 5, 2018
• Est. primary completion date: June 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Common Cold

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	analyze & realize GmbH	Berlin
Germany	Barbara Grube	Berlin
Germany	Dr. med. Petra Sandow and Eugenia Fischkina	Berlin
Germany	Dr. med. Ruhland	Berlin
Germany	Klinische Forschung Berlin	Berlin
Germany	POLIKUM Institut GmbH	Berlin
Germany	Thomas Wünsche	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Enzymatica AB	Analyze & Realize

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of common cold symptoms	Number of days since start of cold symptoms until the end of the symptoms (defined as the last day with one or more symptoms followed by at least two symptom-free days (subjects have to answer "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row)).	16+/-4 days from start of common cold symptoms
Other	Use of concomitant treatment/remedies	Use of any concomitant treatment/remedies, reported in subject diary once daily, in the evening	16+/-4 days from start of common cold symptoms
Other	Global evaluation of efficacy by subjects at study end	The subjects in the verum group will evaluate the efficacy of the IP (global scaled evaluation with "very good", "good", "moderate" and "poor") at study end.	16+/-4 days from start of common cold symptoms
Primary	Difference in the Jackson scale between the study groups	Jackson scale - total score, local symptoms, systemic symptoms, 2-item score (sore throat & malaise) as recorded in subject diary twice daily, morning and evening). The Jackson score is calculated by summing the following 8 symptom scores: sore throat, blocked nose, runny nose, cough and sneezing (local symptoms) as well as headache, malaise, and chilliness (systemic symptoms). Symptoms are assessed on a 4-point scale: 0 = none (symptom not present), 1 = mild (sensible, but not disturbing or irritating), 2 = moderate (symptoms sometimes disturbing/irritating), 3 = severe (symptoms disturbing/ irritating most of the time).	16+/-4 days from start of common cold symptoms
Primary	Difference in WURSS-21 Quality of Life sub score between the study groups	WURSS-21 Quality of Life (QoL) recorded in subject diary once daily, in the evening. WURSS-21 is an evaluative illness-specific quality of life instrument with 21 items, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). In this study, the QoL part of the WURSS-21 will be applied, from item 12 ("think clearly") to item 20 ("live your personal life").	16+/-4 days from start of common cold symptoms
Primary	Difference in the Sore Throat Scale between the study groups	The Sore Throat Scale is a 0-10 Likert scale where 0=not sore and 10=very sore. Recorded in subject diary twice daily, morning and evening.	16+/-4 days from start of common cold symptoms
Primary	Difference in the Irritated Throat Scale between the study groups	Irritated Throat Scale is a 0-10 Likert scale where 0=not irritated and 10=very irritated. Recorded in subject diary twice daily, morning and evening.	16+/-4 days from start of common cold symptoms
Primary	Percentage of subjects with prevention of cold outburst	Based on the assessment of the symptoms recorded in the diary by means of the specified criteria for a common cold episode, as well as the evaluation of any symptoms by the investigator at V2 (whether they are attributable to common cold), the percentage of subjects with prevention of common cold outburst (upon originally having experienced initial symptoms) will be assessed.	Within 3 days from symptom start
Primary	Difference in number of findings during physical examination compared between the study groups	Physical examination will be performed using standard products and procedures at all study visits. Physical examination by standard clinical examination of the gastrointestinal tract, cardiovascular system, eyes, respiratory tract, lymph nodes, musculoskeletal system, neurological functions, urogenital tract, thyroid gland and skin.	From randomisation through study completion, maximum 16 weeks
Primary	Blood pressure (mmHg) compared between the study groups	Sitting blood pressure (mmHg), systolic and diastolic, will be measured using standard products and procedures at all study visits.	From randomisation through study completion, maximum 16 weeks
Primary	Pulse rate (bpm) compared between the study groups	Pulse rate (bpm) will be measured using standard products and procedures at all study visits.	From randomisation through study completion, maximum 16 weeks
Primary	Number of subjects with adverse events	Any AE that occurs during the course of the study.	From randomisation through study completion, maximum 16 weeks
Primary	Number of device deficiencies	Device deficiencies occurring in the active group (verum)	During IP use, maximum 12 days from symptom start