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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 : Recruiting
First Posted : January 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 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) ]
    WURSS-21 QoL sub score



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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


Contacts
Contact: Ida Nelson +46 46 286 31 00 ida.nelson@enzymatica.com

Locations
Germany
analyze & realize GmbH Recruiting
Berlin, Germany
Contact: Udo Bongartz, Dr. med.         
emovis GmbH Recruiting
Berlin, Germany
Contact: Luci Magimaiseelan         
Klinische Forschung Berlin-Mitte GmbH Recruiting
Berlin, Germany
Contact: Candy von Münchhausen         
Klinische Forschung Berlin Recruiting
Berlin, Germany
Contact: Isabelle Schenkenberger         
Polikum Institut GmbH Recruiting
Berlin, Germany
Contact: Felix Pröpper, Dr.         
Praxis Frau Barbara Grube Recruiting
Berlin, Germany
Contact: Barbara Grube         
Thomas Wünsche Recruiting
Berlin, Germany
Contact: Thomas Wünsche         
BioTeSys GmbH Recruiting
Esslingen, Germany
Contact: Daniel Menzel, Dr. med.         
Praxis Dr. med. Gudrun Ruhland Recruiting
Koßdorf, Germany
Contact: Gudrun Ruhland, Dr. med.         
SIBAmed Studienzentrum GmbH und Co. KG Recruiting
Leipzig, Germany
Contact: Helena Sigal         
Sponsors and Collaborators
Enzymatica AB
Investigators
Principal Investigator: Ralf Uebelhack, Prof. Dr. med. analyze & realize GmbH

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: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases