Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03831763
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Analyze & Realize
Information provided by (Responsible Party):
Enzymatica AB

Brief Summary:
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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 25, 2018
Actual Primary Completion Date : June 5, 2018
Actual Study Completion Date : June 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

Arm Intervention/treatment
Active Comparator: ColdZyme Device: 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



Primary Outcome Measures :
  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 Outcome Measures:
  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.



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.


Layout table for eligibility information
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:

    • 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

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): NCT03831763


Locations
Layout table for location information
Germany
analyze & realize GmbH
Berlin, Germany
Barbara Grube
Berlin, Germany
Dr. med. Petra Sandow and Eugenia Fischkina
Berlin, Germany
Dr. med. Ruhland
Berlin, Germany
Klinische Forschung Berlin
Berlin, Germany
POLIKUM Institut GmbH
Berlin, Germany
Thomas Wünsche
Berlin, Germany
Sponsors and Collaborators
Enzymatica AB
Analyze & Realize
Investigators
Layout table for investigator information
Principal Investigator: Ralf Uebelhack, Prof. MD analyze & realize GmbH

Layout table for additonal information
Responsible Party: Enzymatica AB
ClinicalTrials.gov Identifier: NCT03831763     History of Changes
Other Study ID Numbers: 016317
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: August 21, 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 hte 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 hte approved proposal. Proposals should be directed to fredrik.lindberg@enzymatica.com. To gain access, data requestors will need to signa data access agreement.

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