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

Inclusion Criteria: I1. Subject aged between 18 and 65 years (limits included); I2. Subjects with earlysymptoms of common cold (onset less than or equal to 48 hours before inclusion uponsubjects' declaration); I3. Subjects with:

• A minimum nasal congestion score (blocked nose) of 2 (moderate) according to a 4-pointscale (0 not present; 1 mild; 2 moderate; and 3 severe) assessed by Likert scale,
• Presenting a minimum of two common cold symptoms (runny nose, blocked nose, sorethroat, and/or cough) at inclusion visit (V1) assessed with a score ≥ 1 according to a 4-point scale (0 not present; 1 mild; 2 moderate; and 3 severe) assessed by Likert,
• Minimum plugged nose (nasal congestion) score of 3 (≥ 3) assessed by WURSS-21; I4. For women:
• Non menopausal with the same reliable contraception since at least 2 cycles before thebeginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicide gel, any oral contraceptive, intrauterine device, subcutaneouscontraceptive implant, vaginal ring, surgical intervention (bilateral tubal ligationor ovariectomy or hysterectomy), ESSURE system),
• Menopausal without or with hormone replacement therapy; I5. Subject with good generaland mental health according to the investigator opinion: no clinically significant andrelevant abnormalities of medical history or physical examination; I6. Subject ableand willing to participate to the study by complying with the protocol procedures asevidenced by his dated and signed informed consent form; I7. Subject affiliated with asocial security scheme; I8. Subject who agree to be registered on the volunteers inbiomedical research file.

Exclusion Criteria: E1. Subjects with nasal polyps/polyposis or nasal septum malformations or other nasalstructural abnormalities that would compromise administration of the nasal spray (based onthe declaration of the subjects); E2. Subjects with any other acute ear, nose, and throatand respiratory tract disease than the common cold (eg, tonsillitis, otitis, bronchitis)and chronic sinusitis or allergic rhinitis; E3. Subject suffering from a severe chronicdisease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, or otherchronic respiratory trouble, etc.); E4. Subject under:

• Concomitant treatment that might impair the trial results (eg, decongestants, localanesthetics, topical corticosteroids, saline solution) during the seven days prior toenrollment in the trial,
• Cough treatment or NSAID or any other treatment for the common cold during the sevendays prior to enrollment in the trial,
• Any dietary supplement or probiotic; E5. Subjects with known or suspectedhypersensitivity to the investigational device ingredients or to ingredients whichcould cause crossed allergia as cypress, peach or citrus fruit; E6. Subjects not fullyvaccinated against SARS-CoV-2 virus; E7. Subjects positive for SARS-CoV-2 tested byrapid antigen test at V1; E8. Subjects with fever ≥ 38 °C; E9. Pregnant or lactatingwomen or intending to become pregnant within the month ahead and during the wholestudy; E10. Having a lifestyle deemed incompatible with the study according to the investigator asdescribed below:
• Consuming more than 2 standard drinks of alcoholic daily or 14 weekly or not agreeingto 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 intensephysical activity a week, walking excluded); E11. Subject taking part in anotherclinical trial or being in the exclusion period of a previous clinical trial; E12.Subject having received, during the last 12 months, indemnities for clinical trialhigher 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 informedconsent;