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

Common Cold Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794804
• Other study ID #: 008618
• Status: Completed
• Phase: N/A
• Start date: January 28, 2019
• Est. completion date: June 26, 2019

Study information

• Verified date: August 2019
• Source: Enzymatica AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 701
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Common Cold

Intervention

Device:
• ColdZyme
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 Placebo
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.

Locations

Country	Name	City	State
Germany	analyze & realize GmbH	Berlin
Germany	emovis GmbH	Berlin
Germany	Klinische Forschung Berlin	Berlin
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	Polikum Institut GmbH	Berlin
Germany	Praxis Frau Barbara Grube	Berlin
Germany	Thomas Wünsche	Berlin
Germany	BioTeSys GmbH	Esslingen
Germany	Praxis Dr. med. Gudrun Ruhland	Koßdorf
Germany	SIBAmed Studienzentrum GmbH und Co. KG	Leipzig

Sponsors (2)

Lead Sponsor	Collaborator
Enzymatica AB	Analyze & Realize

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety endpoint: Physical examination	Physical examination: 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 enrolment through study completion, maximum 16 weeks
Other	Safety endpoint: Vital signs	Vital signs: blood pressure (mmHg)	From enrolment through study completion, maximum 16 weeks
Other	Safety endpoint: Vital signs	Vital signs: pulse rate (bpm)	From enrolment through study completion, maximum 16 weeks
Other	Safety endpoint: Global evaluation of tolerability by subjects and investigators	Global evaluation of tolerability by subjects and investigators at study end, 4-point categorical scale: "very good", "good", "moderate" and "poor"	From enrolment through study completion, maximum 16 weeks
Other	Safety endpoint: Assessment of adverse events	Assessment of adverse events throughout the study	From enrolment through study completion, maximum 16 weeks
Other	Safety endpoint: Assessment of device deficiencies	Assessment of device deficiencies at V2 and V3	From enrolment through study completion, maximum 16 weeks
Primary	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	1. Composite daily severity of all symptoms within the Jackson score	The first major secondary endpoint: AUC days 1-8 composite daily severity of all symptoms within the Jackson score (mean of morning and evening) (day 1 is the first day of symptom recording)	Days 1-8 (day 1 is the first day of symptoms)
Secondary	2. Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms	The second major secondary endpoint: Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms - immune suppressants/immune stimulants, analgesics/ anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray or any medication/treatment known to affect common cold symptoms - at any dose, expressed as number of days with concomitant treatment during the first 4 days for each subject (based on diary data).	Days 1-4 (day 1 is the first day of symptoms)
Secondary	Other secondary endpoints: AUC days 1-8 for each single WURSS-21 QoL subscore item	AUC days 1-8 for each single WURSS-21 QoL subscore item	Days 1-8 (day 1 is the first day of symptoms)
Secondary	AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening)	AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item	Days 1-8 (day 1 is the first day of symptoms)
Secondary	AUC days 1-8 composite daily severity of each individual symptom of the Jackson score (mean of morning and evening)	AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item	Days 1-8 (day 1 is the first day of symptoms)
Secondary	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	Frequency of subjects with use of concomitant treatment (including natural health products) that may affect common cold symptoms - immune suppressants/immune stimulants, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray or any medication/treatment known to affect common cold symptoms - at any dose	Days 1-4
Secondary	Assessment of duration of first intense phase	Assessment of duration of first intense phase, expressed as number of days from start of treatment until scoring <5 in total Jackson score	From enrolment through study completion, maximum 16 weeks
Secondary	Assessment of symptom intensity	Assessment of symptom intensity, expressed as mean total Jackson score days 1-4	Days 1-4
Secondary	Assessment of symptom sore throat per Sore Throat Scale	Assessment of symptom sore throat per Sore Throat Scale, expressed as AUC days 1-8	Days 1-8
Secondary	Percentage of subjects with confirmed common cold at Visit 2	Percentage of subjects with confirmed common cold at Visit 2 (from all subjects with V2), which should take place within 1-3 days after symptom start	1-3 days after symptom start
Secondary	Global evaluation of efficacy by subjects and investigators at study end	Global evaluation of efficacy by subjects and investigators at study end, 4-point categorical scale: "very good", "good", "moderate" and "poor"	From enrolment through study completion, maximum 16 weeks