An interventional study of Azeol spray nasal and Placebo nasal spray in Nasal Congestion, sponsored by Larena SAS. Completed at 2 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-14.
Sponsored by Larena SAS · Not applicable, Interventional, and Treatment
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.
111 studies on the registry are indexed under Nasal Obstruction; 27 are open to participants now.
This study's enrollment of 144 is above the median of 52 across 82 interventional studies indexed under Nasal Obstruction.
Browse Nasal Obstruction studies →Larena SAS is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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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:
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
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
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).
with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients
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
Time frame: 2 days
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
Time frame: 7 days
Area Under the Curve for sick feeling score, global severity score, symptom score and for quality-of-life score
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 7 days
Subject's assessment of common cold feeling compared to the day before
item 21 of a patient questionnaire (WURSS-21)
Time frame: 7 days
Subjects' assessment of efficacy
evaluated at the end of trial visit with a patient's satisfaction questionnaire
Time frame: 7 days
Presence of secondary infections in the month after the D7
assessed by investigator
Time frame: 1 month after D7
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
Time frame: 3 days
Safety endpoint
The hemodynamic parameters, resting Heart Rate, Systolic Blood Pressure and Diastolic Blood Pressure
Time frame: First day and 3 days
Safety endpoint
Frequency of adverse events
Time frame: 1 month after D7
Plan to share: No — IPD won't be shared
No publications or documents are linked to this record.
Ran from Nov 2021 to primary completion in Mar 2023, 16 months.
Of 46 interventional studies with no phase under Nasal Obstruction, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Larena SAS