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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
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
CEN Nutriment
Dijon, France
Biofortis - Unité d'investigation clinique
Saint-Herblain, France
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
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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