Effectiveness of a Nasal Spray on Viral Respiratory Infections

Patients are recruited at the study site by the principal investigator, who gives a brief presentation of the study. Eligible, informed patients who sign a consent form are included and randomized.

All patients undergo three nasal swabs: at the time of enrolment, then 24 hours and 84 hours later, and complete a daily questionnaire on a secure mobile application dedicated to patient reported outcomes to assess their symptoms and provide information on any analgesic or antipyretic medication they may have been taking.

Patients randomized to the intervention group are asked to use the nasal spray as recommended and to report any difficulties with the device.

A final visit is organized on day 8 at the investigation center under the supervision of the investigator.

Inclusion criteria

• With early symptoms of respiratory infection (onset less than 48 hours before inclusion) of mild to moderate intensity (TSS ≥ 2 and < 9).
• Having a mobile phone allowing using the patient reported outcome App. (NursTrial®).
• Patient able to understand and comply with protocol requirements and instructions, including answering a questionnaire on a mobile phone, as required by protocol.
• Signed informed consent.
• Affiliated to a French Health insurance scheme.

Exclusion criteria

• Concomitant disease or infection that could interfere with participation in the study: acute ear, nose, and throat and respiratory tract disease other than the common cold, flu or COVID (e.g., tonsillitis, otitis, bronchitis) and chronic sinusitis or allergic rhinitis, or other reasons for nasal obstruction and other past or present conditions and treatments that could influence symptom scores.
• Severe nasal septum deviation or other conditions that could cause nasal obstruction such as the presence of nasal polyps.
• Known or suspected intolerance or hypersensitivity, including history of allergies, to any component investigational device material, any history of drug hypersensitivity.
• Concomitant treatment that might impair the trial results (i.e., decongestants, local anesthetics, topical corticosteroids, saline solution) during the seven days prior to inclusion.
• Smokers.
• Have a condition or is taking a medication that the Investigator and/or designee believes could jeopardize the safety of the subject, would interfere with the evaluation, or confound the interpretation of the study results.
• Non-compliant or may not respect the constraints imposed by the protocol.
• Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial;
• Woman of childbearing age (except menopausal, hysterectomised, sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant, or condoms).
• Person belonging to a population referred to in articles 64 (incapacitated subjects), 65 (minors), 66 (pregnant or breastfeeding women), 67 (persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision) and 68 (patients in emergency) of the Medical Device Regulation.