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

August 19, 2019 updated by: Enzymatica AB

Single (Investigator)-Blind, Randomized, Parallel-group Study to Evaluate the Use of Various Assessments of Common Cold Symptoms for Proof of Efficacy of CMS016317

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.

No Intervention: Optional care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the Jackson scale between the study groups
Time Frame: 16+/-4 days from start of common cold symptoms
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
Difference in WURSS-21 Quality of Life sub score between the study groups
Time Frame: 16+/-4 days from start of common cold symptoms
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
Difference in the Sore Throat Scale between the study groups
Time Frame: 16+/-4 days from start of common cold symptoms
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
Difference in the Irritated Throat Scale between the study groups
Time Frame: 16+/-4 days from start of common cold symptoms
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
Percentage of subjects with prevention of cold outburst
Time Frame: Within 3 days from symptom start
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
Difference in number of findings during physical examination compared between the study groups
Time Frame: From randomisation through study completion, maximum 16 weeks
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
Blood pressure (mmHg) compared between the study groups
Time Frame: From randomisation through study completion, maximum 16 weeks
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
Pulse rate (bpm) compared between the study groups
Time Frame: From randomisation through study completion, maximum 16 weeks
Pulse rate (bpm) will be measured using standard products and procedures at all study visits.
From randomisation through study completion, maximum 16 weeks
Number of subjects with adverse events
Time Frame: From randomisation through study completion, maximum 16 weeks
Any AE that occurs during the course of the study.
From randomisation through study completion, maximum 16 weeks
Number of device deficiencies
Time Frame: During IP use, maximum 12 days from symptom start
Device deficiencies occurring in the active group (verum)
During IP use, maximum 12 days from symptom start

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of common cold symptoms
Time Frame: 16+/-4 days from start 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
Use of concomitant treatment/remedies
Time Frame: 16+/-4 days from start of common cold symptoms
Use of any concomitant treatment/remedies, reported in subject diary once daily, in the evening
16+/-4 days from start of common cold symptoms
Global evaluation of efficacy by subjects at study end
Time Frame: 16+/-4 days from start of common cold symptoms
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2018

Primary Completion (Actual)

June 5, 2018

Study Completion (Actual)

June 5, 2018

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

February 5, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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