Clinical trial NCT03794804: Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold
Official title: Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Cold
Lead sponsor: Enzymatica AB
Sponsor class: INDUSTRY
Collaborators: name: Analyze & Realize
First posted: 2019-01-07
Enrollment: 701
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: WURSS-21 QoL sub score
timeFrame: Days 1-8 (day 1 is the first day of symptoms)
Secondary outcomes:
measure: 1. Composite daily severity of all symptoms within the Jackson score
timeFrame: Days 1-8 (day 1 is the first day of symptoms)
measure: 2. Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms
timeFrame: Days 1-4 (day 1 is the first day of symptoms)
measure: Other secondary endpoints: AUC days 1-8 for each single WURSS-21 QoL subscore item
timeFrame: Days 1-8 (day 1 is the first day of symptoms)
measure: AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening)
timeFrame: Days 1-8 (day 1 is the first day of symptoms)
measure: AUC days 1-8 composite daily severity of each individual symptom of the Jackson score (mean of morning and evening)
timeFrame: Days 1-8 (day 1 is the first day of symptoms)
measure: Frequency of subjects with use of concomitant treatment that may affect common cold symptoms or any medication/treatment known to affect common cold symptoms - at any dose
timeFrame: Days 1-4
measure: Assessment of duration of first intense phase
timeFrame: From enrolment through study completion, maximum 16 weeks
measure: Assessment of symptom intensity
timeFrame: Days 1-4
measure: Assessment of symptom sore throat per Sore Throat Scale
timeFrame: Days 1-8
measure: Percentage of subjects with confirmed common cold at Visit 2
timeFrame: 1-3 days after symptom start
measure: Global evaluation of efficacy by subjects and investigators at study end
timeFrame: From enrolment through study completion, maximum 16 weeks
Other outcomes:
measure: Safety endpoint: Physical examination
timeFrame: From enrolment through study completion, maximum 16 weeks
measure: Safety endpoint: Vital signs
timeFrame: From enrolment through study completion, maximum 16 weeks
measure: Safety endpoint: Vital signs
timeFrame: From enrolment through study completion, maximum 16 weeks
measure: Safety endpoint: Global evaluation of tolerability by subjects and investigators
timeFrame: From enrolment through study completion, maximum 16 weeks
measure: Safety endpoint: Assessment of adverse events
timeFrame: From enrolment through study completion, maximum 16 weeks
measure: Safety endpoint: Assessment of device deficiencies
timeFrame: From enrolment through study completion, maximum 16 weeks
Locations:
city: Berlin
country: Germany
facility: analyze & realize GmbH
city: Berlin
country: Germany
facility: emovis GmbH
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: Klinische Forschung Berlin
city: Berlin
country: Germany
facility: Polikum Institut GmbH
city: Berlin
country: Germany
facility: Praxis Frau Barbara Grube
city: Berlin
country: Germany
facility: Thomas Wünsche
city: Esslingen
country: Germany
facility: BioTeSys GmbH
city: Koßdorf
country: Germany
facility: Praxis Dr. med. Gudrun Ruhland
city: Leipzig
country: Germany
facility: SIBAmed Studienzentrum GmbH und Co. KG
Study officials:
affiliation: analyze & realize GmbH
name: Ralf Uebelhack, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: