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

Not Applicable

Completed

• Conditions: Common Cold
• Interventions: Device: ColdZyme Placebo; Device: ColdZyme

• Registration Number: NCT03794804
• Lead Sponsor: Enzymatica AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-04
• Study First Posted: 2019-01-07
• Study Start: 2019-01-28
• Primary Completion: 2019-06-26
• Study Completion: 2019-06-26
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 701

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	ColdZyme Placebo	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.
ColdZyme	ColdZyme	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.

Primary Outcome Measures

Name	Time	Method
WURSS-21 QoL sub score	Days 1-8 (day 1 is the first day of symptoms)	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.

Secondary Outcome Measures

Name	Time	Method
1. Composite daily severity of all symptoms within the Jackson score	Days 1-8 (day 1 is the first day of symptoms)	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)
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 all local symptoms within the Jackson score (mean of morning and evening) item
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)	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).
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 for each single WURSS-21 QoL subscore item
Assessment of symptom sore throat per Sore Throat Scale	Days 1-8	Assessment of symptom sore throat per Sore Throat Scale, expressed as AUC days 1-8
Percentage of subjects with confirmed common cold at Visit 2	1-3 days after symptom start	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
Global evaluation of efficacy by subjects and investigators at study end	From enrolment through study completion, maximum 16 weeks	Global evaluation of efficacy by subjects and investigators at study end, 4-point categorical scale: "very good", "good", "moderate" and "poor"
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)	AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item
Assessment of symptom intensity	Days 1-4	Assessment of symptom intensity, expressed as mean total Jackson score days 1-4
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	Days 1-4	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
Assessment of duration of first intense phase	From enrolment through study completion, maximum 16 weeks	Assessment of duration of first intense phase, expressed as number of days from start of treatment until scoring \<5 in total Jackson score

Trial Locations

Locations (10)

analyze & realize GmbH; 🇩🇪 Berlin, Germany

Klinische Forschung Berlin; 🇩🇪 Berlin, Germany

Polikum Institut GmbH; 🇩🇪 Berlin, Germany

Klinische Forschung Berlin-Mitte GmbH; 🇩🇪 Berlin, Germany

Praxis Frau Barbara Grube; 🇩🇪 Berlin, Germany

emovis GmbH; 🇩🇪 Berlin, Germany

Thomas Wünsche; 🇩🇪 Berlin, Germany

BioTeSys GmbH; 🇩🇪 Esslingen, Germany

Praxis Dr. med. Gudrun Ruhland; 🇩🇪 Koßdorf, Germany

SIBAmed Studienzentrum GmbH und Co. KG; 🇩🇪 Leipzig, Germany