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NCT Number: NCT03831763

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

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.

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Key information

Conditions

Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barbara Grube, Berlin, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ColdZyme

Device

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 outcomes

  1. 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).

  2. 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").

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Number of device deficiencies

    Time frame: During IP use, maximum 12 days from symptom start

    Device deficiencies occurring in the active group (verum)

Other outcomes

  1. 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)).

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Enzymatica AB

Industry

Collaborators

  • Analyze & Realize

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2019
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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