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

NCT03794804 | Completed

• 1 other identifier: 008618
• Study Type: interventional
• Target: 701
• Locations: 1 country
• Sites: 10

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.

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• WURSS-21 QoL sub score

  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.

  Days 1-8 (day 1 is the first day of symptoms)

Secondary Outcomes (11)

• 1. Composite daily severity of all symptoms within the Jackson score

  Days 1-8 (day 1 is the first day of symptoms)

• 2. Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms

  Days 1-4 (day 1 is the first day of symptoms)

• Other secondary endpoints: AUC days 1-8 for each single WURSS-21 QoL subscore item

  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)

  Days 1-8 (day 1 is the first day of symptoms)

• AUC days 1-8 composite daily severity of each individual symptom of the Jackson score (mean of morning and evening)

  Days 1-8 (day 1 is the first day of symptoms)

Other Outcomes (6)

• Safety endpoint: Physical examination

  From enrolment through study completion, maximum 16 weeks

• Safety endpoint: Vital signs

  From enrolment through study completion, maximum 16 weeks

• Safety endpoint: Vital signs

  From enrolment through study completion, maximum 16 weeks

Study Arms (2)

ColdZyme

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

Interventions

ColdZyme DEVICE

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.

ColdZyme

ColdZyme Placebo DEVICE

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, 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)
• 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,

You may not qualify if:

• 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
• 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
• 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/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
• 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

Sponsors & Collaborators

• Enzymatica AB: lead
• Analyze & Realize: collaborator

Study Sites (10)

analyze & realize GmbH

Berlin, Germany

Location

emovis GmbH

Berlin, Germany

Location

Klinische Forschung Berlin-Mitte GmbH

Berlin, Germany

Location

Klinische Forschung Berlin

Berlin, Germany

Location

Polikum Institut GmbH

Berlin, Germany

Location

Praxis Frau Barbara Grube

Berlin, Germany

Location

Thomas Wünsche

Berlin, Germany

Location

BioTeSys GmbH

Esslingen am Neckar, Germany

Location

Praxis Dr. med. Gudrun Ruhland

Koßdorf, Germany

Location

SIBAmed Studienzentrum GmbH und Co. KG

Leipzig, Germany

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Ralf Uebelhack, Prof. Dr. med.

  analyze & realize GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 7, 2019
• Study Start: January 28, 2019
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

DE (10)