- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05159271
Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults (EXSPRAY)
Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults: the EXSPRAY Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caroline Gal
- Phone Number: +33 0145517877
- Email: c.gal@pileje.com
Study Locations
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Dijon, France, 21000
- CEN Nutriment
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Saint-Herblain, France, 44800
- Biofortis - Unité d'investigation clinique
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 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.
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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).
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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
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with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
relief of nasal congestion at 2 days
Time Frame: 2 days
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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
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2 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
relief of nasal congestion
Time Frame: 7 days
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Change from baseline in the relief of nasal congestion, assessed at the end of each day after both spraying sessions with a patient questionnaire
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7 days
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Area Under the Curve for sick feeling score, global severity score, symptom score and for quality-of-life score
Time Frame: 7 days
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Area Under the Curve for sick feeling score, global severity score, symptom score and for quality-of-life score, assessed at the end of each day after both spraying sessions with a patient questionnaire
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7 days
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Area Under the Curve for common cold symptoms
Time Frame: 7 days
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Area Under the Curve for common cold symptoms assessed at the end of each day after both spraying sessions with a patient questionnaire
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7 days
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Area Under the Curve for nine quality-of-life items
Time Frame: 7 days
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Area Under the Curve for nine quality-of-life items (Think clearly; Sleep well; Breathe easily; Walk, climb stairs, exercise; Accomplish daily activities; Work outside the home; Work inside the home; Interact with others; Live your personal life), assessed at the end of each day after both spraying sessions with a patient questionnaire
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7 days
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Area Under the Curve for the total nasal airway resistance to airflow
Time Frame: First day
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Area Under the Curve for the total nasal airway resistance to airflow using the rhinomanometry after treatment at day 1
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First day
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Time to onset of subjective relief nasal congestion from day 1
Time Frame: 7 days
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relief of symptoms defined when symptom absent is declared for plugged nose with a patient questionnaire
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7 days
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Time to onset of subjective relief symptoms from day 1
Time Frame: 7 days
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relief of symptoms defined when symptom absent is declared for all symptoms with a patient questionnaire
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7 days
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Subject's assessment of common cold feeling compared to the day before
Time Frame: 7 days
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item 21 of a patient questionnaire (WURSS-21)
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7 days
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Subjects' assessment of efficacy
Time Frame: 7 days
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evaluated at the end of trial visit with a patient's satisfaction questionnaire
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7 days
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Presence of secondary infections in the month after the D7
Time Frame: 1 month after D7
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assessed by investigator
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1 month after D7
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of cold viruses in nasal fluid samples
Time Frame: 3 days
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Viral load (change from baseline) on Day 3 for various virus types and number of subjects with cleared viral infections
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3 days
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Safety endpoint
Time Frame: First day and 3 days
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The hemodynamic parameters, resting Heart Rate, Systolic Blood Pressure and Diastolic Blood Pressure
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First day and 3 days
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Safety endpoint
Time Frame: 1 month after D7
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Frequency of adverse events
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1 month after D7
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEC19217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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