Last updated: February 19, 2024
Sponsor: CEN Biotech
Overall Status: Active - Recruiting
Phase
N/A
Condition
Common Cold
Acute Rhinitis
Respiratory Syncytial Virus (Rsv) Infection
Treatment
Nasal Spray HSV Treatment
Clinical Study ID
NCT06278324
C1736
2023-A02286-39
Ages 18-84 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- With early symptoms of respiratory infection (onset less than 48 hours beforeinclusion) 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
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 allergicrhinitis, or other reasons for nasal obstruction and other past or present conditionsand treatments that could influence symptom scores.
- Severe nasal septum deviation or other conditions that could cause nasal obstructionsuch as the presence of nasal polyps.
- Known or suspected intolerance or hypersensitivity, including history of allergies, toany component investigational device material, any history of drug hypersensitivity.
- Concomitant treatment that might impair the trial results (i.e., decongestants, localanesthetics, topical corticosteroids, saline solution) during the seven days prior toinclusion.
- Smokers.
- Have a condition or is taking a medication that the Investigator and/or designeebelieves could jeopardize the safety of the subject, would interfere with theevaluation, 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 previousclinical trial;
- Woman of childbearing age (except menopausal, hysterectomised, sterilized) not usingeffective contraception (oral contraceptives, intra-uterine device, contraceptiveimplant, or condoms).
- Person belonging to a population referred to in articles 64 (incapacitated subjects), 65 (minors), 66 (pregnant or breastfeeding women), 67 (persons performing mandatorymilitary service, persons deprived of liberty, persons who, due to a judicialdecision) and 68 (patients in emergency) of the Medical Device Regulation.
Study Design
Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Nasal Spray HSV Treatment
Phase:
Study Start date:
January 26, 2024
Estimated Completion Date:
July 31, 2024
Study Description
Connect with a study center
Cen Experimental
Dijon, Burgundy 21000
FranceActive - Recruiting
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