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

Primary Purpose

Common Cold

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ColdZyme
Sponsored by
Enzymatica AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Cold

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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:

    • 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

Sites / Locations

  • analyze & realize GmbH
  • Barbara Grube
  • Dr. med. Petra Sandow and Eugenia Fischkina
  • Dr. med. Ruhland
  • Klinische Forschung Berlin
  • POLIKUM Institut GmbH
  • Thomas Wünsche

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

ColdZyme

Optional care only

Arm Description

Outcomes

Primary Outcome Measures

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).
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").
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.
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.
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.
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.
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.
Pulse rate (bpm) compared between the study groups
Pulse rate (bpm) will be measured using standard products and procedures at all study visits.
Number of subjects with adverse events
Any AE that occurs during the course of the study.
Number of device deficiencies
Device deficiencies occurring in the active group (verum)

Secondary Outcome Measures

Full Information

First Posted
January 21, 2019
Last Updated
August 19, 2019
Sponsor
Enzymatica AB
Collaborators
Analyze & Realize
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1. Study Identification

Unique Protocol Identification Number
NCT03831763
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
June 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enzymatica AB
Collaborators
Analyze & Realize

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ColdZyme
Arm Type
Active Comparator
Arm Title
Optional care only
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
ColdZyme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in the Jackson scale between the study groups
Description
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).
Time Frame
16+/-4 days from start of common cold symptoms
Title
Difference in WURSS-21 Quality of Life sub score between the study groups
Description
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").
Time Frame
16+/-4 days from start of common cold symptoms
Title
Difference in the Sore Throat Scale between the study groups
Description
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.
Time Frame
16+/-4 days from start of common cold symptoms
Title
Difference in the Irritated Throat Scale between the study groups
Description
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.
Time Frame
16+/-4 days from start of common cold symptoms
Title
Percentage of subjects with prevention of cold outburst
Description
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.
Time Frame
Within 3 days from symptom start
Title
Difference in number of findings during physical examination compared between the study groups
Description
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.
Time Frame
From randomisation through study completion, maximum 16 weeks
Title
Blood pressure (mmHg) compared between the study groups
Description
Sitting blood pressure (mmHg), systolic and diastolic, will be measured using standard products and procedures at all study visits.
Time Frame
From randomisation through study completion, maximum 16 weeks
Title
Pulse rate (bpm) compared between the study groups
Description
Pulse rate (bpm) will be measured using standard products and procedures at all study visits.
Time Frame
From randomisation through study completion, maximum 16 weeks
Title
Number of subjects with adverse events
Description
Any AE that occurs during the course of the study.
Time Frame
From randomisation through study completion, maximum 16 weeks
Title
Number of device deficiencies
Description
Device deficiencies occurring in the active group (verum)
Time Frame
During IP use, maximum 12 days from symptom start
Other Pre-specified Outcome Measures:
Title
Duration of common cold symptoms
Description
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)).
Time Frame
16+/-4 days from start of common cold symptoms
Title
Use of concomitant treatment/remedies
Description
Use of any concomitant treatment/remedies, reported in subject diary once daily, in the evening
Time Frame
16+/-4 days from start of common cold symptoms
Title
Global evaluation of efficacy by subjects at study end
Description
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.
Time Frame
16+/-4 days from start of common cold symptoms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf Uebelhack, Prof. MD
Organizational Affiliation
analyze & realize GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
analyze & realize GmbH
City
Berlin
Country
Germany
Facility Name
Barbara Grube
City
Berlin
Country
Germany
Facility Name
Dr. med. Petra Sandow and Eugenia Fischkina
City
Berlin
Country
Germany
Facility Name
Dr. med. Ruhland
City
Berlin
Country
Germany
Facility Name
Klinische Forschung Berlin
City
Berlin
Country
Germany
Facility Name
POLIKUM Institut GmbH
City
Berlin
Country
Germany
Facility Name
Thomas Wünsche
City
Berlin
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported, after deidentification (text, tables, figures and appendices) will be shared with researchers who provide a methodologically sound proposal, to achieve aims in hte approved proposal.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Individual participant data that underlie the results reported, after deidentification (text, tables, figures and appendices) will be shared with researchers who provide a methodologically sound proposal, to achieve aims in hte approved proposal. Proposals should be directed to fredrik.lindberg@enzymatica.com. To gain access, data requestors will need to signa data access agreement.

Learn more about this trial

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

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