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

NCT05159271 | Completed

• 1 other identifier: PEC19217
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Nasal Congestion

Outcome Measures

Primary Outcomes (1)

• relief of nasal congestion at 2 days

  change from baseline in the relief of nasal congestion defined by "plugged nose", after 2 days of product intake, assessed at end of day after both spraying sessions with the "plugged nose" question

  2 days

Secondary Outcomes (10)

• relief of nasal congestion

  7 days

• Area Under the Curve for sick feeling score, global severity score, symptom score and for quality-of-life score

  7 days

• Area Under the Curve for common cold symptoms

  7 days

• Area Under the Curve for nine quality-of-life items

  7 days

• Area Under the Curve for the total nasal airway resistance to airflow

  First day

Other Outcomes (3)

• Presence of cold viruses in nasal fluid samples

  3 days

• Safety endpoint

  First day and 3 days

• Safety endpoint

  1 month after D7

Study Arms (2)

Azeol spray nasal group

EXPERIMENTAL

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.

Device: Azeol spray nasal

Placebo group

PLACEBO COMPARATOR

The control product is a placebo with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients

Device: Placebo nasal spray

Interventions

Azeol spray nasal DEVICE

Azeol Spray Nasal is a nasal spray intended to reduce the nasal congestion due to rhinitis, rhinosinusitis and colds which is marketed. The ID is conforming to the European Union (EU) legislation and is bearing the CE-mark. The ID is manufactured by PILEJE S.A.S (France).

Azeol spray nasal group

Placebo nasal spray DEVICE

with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Larena SAS: lead
• BioFortis: collaborator

Study Sites (2)

CEN Nutriment

Dijon, 21000, France

Location

Biofortis - Unité d'investigation clinique

Saint-Herblain, 44800, France

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 16, 2021
• Study Start: November 22, 2021
• Primary Completion: March 24, 2023
• Study Completion: April 25, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)