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| Name | Class |
|---|---|
| BioFortis | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| relief of nasal congestion | Change from baseline in the relief of nasal congestion, assessed at the end of each day after both spraying sessions with a patient questionnaire | 7 days |
| Area Under the Curve for sick feeling score, global severity score, symptom score and for quality-of-life score |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of cold viruses in nasal fluid samples | Viral load (change from baseline) on Day 3 for various virus types and number of subjects with cleared viral infections | 3 days |
| Safety endpoint | The hemodynamic parameters, resting Heart Rate, Systolic Blood Pressure and Diastolic Blood Pressure |
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:
I4. For women:
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:
E10. Having a lifestyle deemed incompatible with the study according to the investigator as described below:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEN Nutriment | Dijon | 21000 | France | |||
| Biofortis - Unité d'investigation clinique |
IPD won't be shared
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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|
| Placebo nasal spray | Device | with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients |
|
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 |
| 7 days |
| Area Under the Curve for common cold symptoms | Area Under the Curve for common cold symptoms assessed at the end of each day after both spraying sessions with a patient questionnaire | 7 days |
| Area Under the Curve for nine quality-of-life items | 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 | 7 days |
| Area Under the Curve for the total nasal airway resistance to airflow | Area Under the Curve for the total nasal airway resistance to airflow using the rhinomanometry after treatment at day 1 | First day |
| Time to onset of subjective relief nasal congestion from day 1 | relief of symptoms defined when symptom absent is declared for plugged nose with a patient questionnaire | 7 days |
| Time to onset of subjective relief symptoms from day 1 | relief of symptoms defined when symptom absent is declared for all symptoms with a patient questionnaire | 7 days |
| Subject's assessment of common cold feeling compared to the day before | item 21 of a patient questionnaire (WURSS-21) | 7 days |
| Subjects' assessment of efficacy | evaluated at the end of trial visit with a patient's satisfaction questionnaire | 7 days |
| Presence of secondary infections in the month after the D7 | assessed by investigator | 1 month after D7 |
| First day and 3 days |
| Safety endpoint | Frequency of adverse events | 1 month after D7 |
| Saint-Herblain |
| 44800 |
| France |
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |