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Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold

Primary Purpose

Common Cold

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ColdZyme
ColdZyme Placebo
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, 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)

  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,

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
    • 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
  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/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
  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
  • emovis GmbH
  • Klinische Forschung Berlin-Mitte GmbH
  • Klinische Forschung Berlin
  • Polikum Institut GmbH
  • Praxis Frau Barbara Grube
  • Thomas Wünsche
  • BioTeSys GmbH
  • Praxis Dr. med. Gudrun Ruhland
  • SIBAmed Studienzentrum GmbH und Co. KG

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ColdZyme

Placebo

Arm Description

ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion. The IP use should start when following conditions have been fulfilled: Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total.

Water based mouth spray manufactured to be similar to ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion. The IP use should start when following conditions have been fulfilled: Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total.

Outcomes

Primary Outcome Measures

WURSS-21 QoL sub score
The primary endpoint is the AUC of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Quality of Life composite subscore during first 8 days of symptoms, to be assessed in comparison between verum and placebo.

Secondary Outcome Measures

1. Composite daily severity of all symptoms within the Jackson score
The first major secondary endpoint: AUC days 1-8 composite daily severity of all symptoms within the Jackson score (mean of morning and evening) (day 1 is the first day of symptom recording)
2. Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms
The second major secondary endpoint: Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms - immune suppressants/immune stimulants, analgesics/ anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray or any medication/treatment known to affect common cold symptoms - at any dose, expressed as number of days with concomitant treatment during the first 4 days for each subject (based on diary data).
Other secondary endpoints: AUC days 1-8 for each single WURSS-21 QoL subscore item
AUC days 1-8 for each single WURSS-21 QoL subscore item
AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening)
AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item
AUC days 1-8 composite daily severity of each individual symptom of the Jackson score (mean of morning and evening)
AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item
Frequency of subjects with use of concomitant treatment that may affect common cold symptoms or any medication/treatment known to affect common cold symptoms - at any dose
Frequency of subjects with use of concomitant treatment (including natural health products) that may affect common cold symptoms - immune suppressants/immune stimulants, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray or any medication/treatment known to affect common cold symptoms - at any dose
Assessment of duration of first intense phase
Assessment of duration of first intense phase, expressed as number of days from start of treatment until scoring <5 in total Jackson score
Assessment of symptom intensity
Assessment of symptom intensity, expressed as mean total Jackson score days 1-4
Assessment of symptom sore throat per Sore Throat Scale
Assessment of symptom sore throat per Sore Throat Scale, expressed as AUC days 1-8
Percentage of subjects with confirmed common cold at Visit 2
Percentage of subjects with confirmed common cold at Visit 2 (from all subjects with V2), which should take place within 1-3 days after symptom start
Global evaluation of efficacy by subjects and investigators at study end
Global evaluation of efficacy by subjects and investigators at study end, 4-point categorical scale: "very good", "good", "moderate" and "poor"

Full Information

First Posted
January 3, 2019
Last Updated
August 20, 2019
Sponsor
Enzymatica AB
Collaborators
Analyze & Realize
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1. Study Identification

Unique Protocol Identification Number
NCT03794804
Brief Title
Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold
Official Title
Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
June 26, 2019 (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 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.

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
701 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ColdZyme
Arm Type
Active Comparator
Arm Description
ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion. The IP use should start when following conditions have been fulfilled: Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Water based mouth spray manufactured to be similar to ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion. The IP use should start when following conditions have been fulfilled: Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total.
Intervention Type
Device
Intervention Name(s)
ColdZyme
Intervention Description
ColdZyme® Mouth Spray, a CE -marked device with the following composition of the spray solution: glycerol, purified water, cod trypsin, ethanol (<1 %), calcium chloride, trometamol and menthol. ColdZyme is a non-sterile mouth spray packaged in a primary container consisting of a 20 ml semi-transparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.
Intervention Type
Device
Intervention Name(s)
ColdZyme Placebo
Intervention Description
The placebo mouth spray solution has the following composition: ethanol (<1 %), menthol and water. The placebo mouth spray is packaged in a primary container consisting of a 20 ml semitransparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.
Primary Outcome Measure Information:
Title
WURSS-21 QoL sub score
Description
The primary endpoint is the AUC of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Quality of Life composite subscore during first 8 days of symptoms, to be assessed in comparison between verum and placebo.
Time Frame
Days 1-8 (day 1 is the first day of symptoms)
Secondary Outcome Measure Information:
Title
1. Composite daily severity of all symptoms within the Jackson score
Description
The first major secondary endpoint: AUC days 1-8 composite daily severity of all symptoms within the Jackson score (mean of morning and evening) (day 1 is the first day of symptom recording)
Time Frame
Days 1-8 (day 1 is the first day of symptoms)
Title
2. Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms
Description
The second major secondary endpoint: Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms - immune suppressants/immune stimulants, analgesics/ anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray or any medication/treatment known to affect common cold symptoms - at any dose, expressed as number of days with concomitant treatment during the first 4 days for each subject (based on diary data).
Time Frame
Days 1-4 (day 1 is the first day of symptoms)
Title
Other secondary endpoints: AUC days 1-8 for each single WURSS-21 QoL subscore item
Description
AUC days 1-8 for each single WURSS-21 QoL subscore item
Time Frame
Days 1-8 (day 1 is the first day of symptoms)
Title
AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening)
Description
AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item
Time Frame
Days 1-8 (day 1 is the first day of symptoms)
Title
AUC days 1-8 composite daily severity of each individual symptom of the Jackson score (mean of morning and evening)
Description
AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item
Time Frame
Days 1-8 (day 1 is the first day of symptoms)
Title
Frequency of subjects with use of concomitant treatment that may affect common cold symptoms or any medication/treatment known to affect common cold symptoms - at any dose
Description
Frequency of subjects with use of concomitant treatment (including natural health products) that may affect common cold symptoms - immune suppressants/immune stimulants, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray or any medication/treatment known to affect common cold symptoms - at any dose
Time Frame
Days 1-4
Title
Assessment of duration of first intense phase
Description
Assessment of duration of first intense phase, expressed as number of days from start of treatment until scoring <5 in total Jackson score
Time Frame
From enrolment through study completion, maximum 16 weeks
Title
Assessment of symptom intensity
Description
Assessment of symptom intensity, expressed as mean total Jackson score days 1-4
Time Frame
Days 1-4
Title
Assessment of symptom sore throat per Sore Throat Scale
Description
Assessment of symptom sore throat per Sore Throat Scale, expressed as AUC days 1-8
Time Frame
Days 1-8
Title
Percentage of subjects with confirmed common cold at Visit 2
Description
Percentage of subjects with confirmed common cold at Visit 2 (from all subjects with V2), which should take place within 1-3 days after symptom start
Time Frame
1-3 days after symptom start
Title
Global evaluation of efficacy by subjects and investigators at study end
Description
Global evaluation of efficacy by subjects and investigators at study end, 4-point categorical scale: "very good", "good", "moderate" and "poor"
Time Frame
From enrolment through study completion, maximum 16 weeks
Other Pre-specified Outcome Measures:
Title
Safety endpoint: Physical examination
Description
Physical examination: 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 enrolment through study completion, maximum 16 weeks
Title
Safety endpoint: Vital signs
Description
Vital signs: blood pressure (mmHg)
Time Frame
From enrolment through study completion, maximum 16 weeks
Title
Safety endpoint: Vital signs
Description
Vital signs: pulse rate (bpm)
Time Frame
From enrolment through study completion, maximum 16 weeks
Title
Safety endpoint: Global evaluation of tolerability by subjects and investigators
Description
Global evaluation of tolerability by subjects and investigators at study end, 4-point categorical scale: "very good", "good", "moderate" and "poor"
Time Frame
From enrolment through study completion, maximum 16 weeks
Title
Safety endpoint: Assessment of adverse events
Description
Assessment of adverse events throughout the study
Time Frame
From enrolment through study completion, maximum 16 weeks
Title
Safety endpoint: Assessment of device deficiencies
Description
Assessment of device deficiencies at V2 and V3
Time Frame
From enrolment through study completion, maximum 16 weeks

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, 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf Uebelhack, Prof. Dr. med.
Organizational Affiliation
analyze & realize GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
analyze & realize GmbH
City
Berlin
Country
Germany
Facility Name
emovis GmbH
City
Berlin
Country
Germany
Facility Name
Klinische Forschung Berlin-Mitte GmbH
City
Berlin
Country
Germany
Facility Name
Klinische Forschung Berlin
City
Berlin
Country
Germany
Facility Name
Polikum Institut GmbH
City
Berlin
Country
Germany
Facility Name
Praxis Frau Barbara Grube
City
Berlin
Country
Germany
Facility Name
Thomas Wünsche
City
Berlin
Country
Germany
Facility Name
BioTeSys GmbH
City
Esslingen
Country
Germany
Facility Name
Praxis Dr. med. Gudrun Ruhland
City
Koßdorf
Country
Germany
Facility Name
SIBAmed Studienzentrum GmbH und Co. KG
City
Leipzig
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 the 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 the approved proposal. Proposals should be directed to fredrik.lindberg@enzymatica.com. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold

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