Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults

Exclusion Criteria

• •E1. Subjects with nasal polyps/polyposis or nasal septum malformations or other nasal structural abnormalities that would compromise administration of the nasal spray (based on the declaration of the subjects); E2. Subjects with any other acute ear, nose, and throat and respiratory tract disease than the common cold (eg, tonsillitis, otitis, bronchitis) and chronic sinusitis or allergic rhinitis; E3. Subject suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, or other chronic respiratory trouble, etc.);
• •E4. Subject under:
• •Concomitant treatment that might impair the trial results (eg, decongestants, local anesthetics, topical corticosteroids, saline solution) during the seven days prior to enrollment in the trial,
• •Cough treatment or NSAID or any other treatment for the common cold during the seven days prior to enrollment in the trial,
• •Any dietary supplement or probiotic; E5. Subjects with known or suspected hypersensitivity to the investigational device ingredients or to ingredients which could cause crossed allergia as cypress, peach or citrus fruit; E6. Subjects not fully vaccinated against SARS-CoV-2 virus; E7. Subjects positive for SARS-CoV-2 tested by rapid antigen test at V1; E8. Subjects with fever ≥ 38 °C; E9. Pregnant or lactating women or intending to become pregnant within the month ahead and during the whole study;
• •E10. Having a lifestyle deemed incompatible with the study according to the investigator as described below:
• •Consuming more than 2 standard drinks of alcoholic daily or 14 weekly or not agreeing to keep his alcohol consumption habits unchanged throughout the study,
• •Smoking more than five cigarettes daily or more than 60 mg of nicotine daily,
• •Practicing high level of physical activity (defined as more than 10 hours of intense physical activity a week, walking excluded); E11. Subject taking part in another clinical trial or being in the exclusion period of a previous clinical trial; E12. Subject having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros; E13. Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision; E14. Subject presenting a psychological or linguistic inability to sign the informed consent;