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

Status: Completed
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The main objective is to evaluate the efficacy of Azéol Spray Nasal, taken two times a day, versus placebo on nasal congestion in subject with common cold.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ I1. Subject aged between 18 and 65 years (limits included); I2. Subjects with early symptoms of common cold (onset less than or equal to 48 hours before inclusion upon subjects' declaration);

⁃ I3. Subjects with:

• A minimum nasal congestion score (blocked nose) of 2 (moderate) according to a 4-point scale (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, sore throat, 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 the beginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicide gel, any oral contraceptive, intrauterine device, subcutaneous contraceptive implant, vaginal ring, surgical intervention (bilateral tubal ligation or ovariectomy or hysterectomy), ESSURE system),

• Menopausal without or with hormone replacement therapy; I5. Subject with good general and mental health according to the investigator opinion: no clinically significant and relevant abnormalities of medical history or physical examination; I6. Subject able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form; I7. Subject affiliated with a social security scheme; I8. Subject who agree to be registered on the volunteers in biomedical research file.

Locations
Other Locations
France
CEN Nutriment
Dijon
Biofortis - Unité d'investigation clinique
Saint-herblain
Time Frame
Start Date: 2021-11-22
Completion Date: 2023-04-25
Participants
Target number of participants: 144
Treatments
Experimental: Azeol spray nasal group
Azéol Spray Nasal is a nasal spray. The constituents responsible for achieving the intended action are: Bifidobacterium breve LA 708, extract of cypres Cupressus sempervirens L., extract of Leguminosae Glycyrrhiza glabra L., glycerin and mannitol.
Placebo_comparator: Placebo group
The control product is a placebo with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients
Related Therapeutic Areas
Sponsors
Collaborators: BioFortis
Leads: Larena SAS

This content was sourced from clinicaltrials.gov

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