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

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ClinicalTrials.gov Identifier: NCT03794804
Recruitment Status : Completed
First Posted : January 7, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Analyze & Realize
Information provided by (Responsible Party):
Enzymatica AB

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.

Condition or disease Intervention/treatment Phase
Common Cold Device: ColdZyme Device: ColdZyme Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 701 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold
Actual Study Start Date : January 28, 2019
Actual Primary Completion Date : June 26, 2019
Actual Study Completion Date : June 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

Arm Intervention/treatment
Active Comparator: ColdZyme

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.

Device: ColdZyme

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.


Placebo Comparator: Placebo

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.

Device: ColdZyme Placebo
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 Measures :
  1. WURSS-21 QoL sub score [ Time Frame: Days 1-8 (day 1 is the first day of symptoms) ]
    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. 1. Composite daily severity of all symptoms within the Jackson score [ Time Frame: Days 1-8 (day 1 is the first day of symptoms) ]
    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. 2. Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms [ Time Frame: Days 1-4 (day 1 is the first day of 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).

  3. Other secondary endpoints: 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) ]
    AUC days 1-8 for each single WURSS-21 QoL subscore item

  4. AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) [ Time Frame: Days 1-8 (day 1 is the first day of symptoms) ]
    AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item

  5. AUC days 1-8 composite daily severity of each individual symptom of the Jackson score (mean of morning and evening) [ Time Frame: Days 1-8 (day 1 is the first day of symptoms) ]
    AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item

  6. 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 [ Time Frame: Days 1-4 ]
    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

  7. Assessment of duration of first intense phase [ Time Frame: From enrolment through study completion, maximum 16 weeks ]
    Assessment of duration of first intense phase, expressed as number of days from start of treatment until scoring <5 in total Jackson score

  8. Assessment of symptom intensity [ Time Frame: Days 1-4 ]
    Assessment of symptom intensity, expressed as mean total Jackson score days 1-4

  9. Assessment of symptom sore throat per Sore Throat Scale [ Time Frame: Days 1-8 ]
    Assessment of symptom sore throat per Sore Throat Scale, expressed as AUC days 1-8

  10. Percentage of subjects with confirmed common cold at Visit 2 [ Time Frame: 1-3 days after symptom start ]
    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

  11. Global evaluation of efficacy by subjects and investigators at study end [ Time Frame: From enrolment through study completion, maximum 16 weeks ]
    Global evaluation of efficacy by subjects and investigators at study end, 4-point categorical scale: "very good", "good", "moderate" and "poor"


Other Outcome Measures:
  1. Safety endpoint: Physical examination [ Time Frame: From enrolment through study completion, maximum 16 weeks ]
    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.

  2. Safety endpoint: Vital signs [ Time Frame: From enrolment through study completion, maximum 16 weeks ]
    Vital signs: blood pressure (mmHg)

  3. Safety endpoint: Vital signs [ Time Frame: From enrolment through study completion, maximum 16 weeks ]
    Vital signs: pulse rate (bpm)

  4. Safety endpoint: Global evaluation of tolerability by subjects and investigators [ Time Frame: From enrolment through study completion, maximum 16 weeks ]
    Global evaluation of tolerability by subjects and investigators at study end, 4-point categorical scale: "very good", "good", "moderate" and "poor"

  5. Safety endpoint: Assessment of adverse events [ Time Frame: From enrolment through study completion, maximum 16 weeks ]
    Assessment of adverse events throughout the study

  6. Safety endpoint: Assessment of device deficiencies [ Time Frame: From enrolment through study completion, maximum 16 weeks ]
    Assessment of device deficiencies at V2 and V3



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794804


Locations
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Germany
analyze & realize GmbH
Berlin, Germany
emovis GmbH
Berlin, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, Germany
Klinische Forschung Berlin
Berlin, Germany
Polikum Institut GmbH
Berlin, Germany
Praxis Frau Barbara Grube
Berlin, Germany
Thomas Wünsche
Berlin, Germany
BioTeSys GmbH
Esslingen, Germany
Praxis Dr. med. Gudrun Ruhland
Koßdorf, Germany
SIBAmed Studienzentrum GmbH und Co. KG
Leipzig, Germany
Sponsors and Collaborators
Enzymatica AB
Analyze & Realize
Investigators
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Principal Investigator: Ralf Uebelhack, Prof. Dr. med. analyze & realize GmbH

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Responsible Party: Enzymatica AB
ClinicalTrials.gov Identifier: NCT03794804     History of Changes
Other Study ID Numbers: 008618
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Beginning 3 months and ending 5 years following article publication.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases