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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    144
  • sponsor
    Larena SAS
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Updated on 22 December 2021
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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.

Description

This study is designed as a multicentric, randomized, double-blind, placebo-controlled with two-arm parallel groups clinical trial. 144 subjects presenting with early symptoms of common cold will be recruited for this study, according to the defined inclusion and exclusion criteria. The main objective is to evaluate the efficacy of Azéol Spray Nasal (Bifidobacterium breve LA 708, extract of cypres Cupressus sempervirens L., extract of Leguminosae Glycyrrhiza glabra L., glycerin and mannitol), taken two times a day, versus placebo on nasal congestion in subject with common cold.

Details
Condition Nasal Congestion
Treatment Placebo nasal spray, Azeol spray nasal
Clinical Study IdentifierNCT05159271
SponsorLarena SAS
Last Modified on22 December 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
-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

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
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