Recurrent Upper-Respiratory Tract Infections
Conditions
Keywords
Recurrent common cold, laryngitis, pharyngitis/tonsillitis, acute rhinitis, acute rhinosinusitis, acute otitis media
Brief summary
The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of younger age who develop infectious diseases more frequently than other children of this age in general.
Interventions
DRUGJ022X ST
Oral administration - During 6 months and according to the approved summary of product characteristics : 1 sachet per day in the morning on an empty stomach * First month: 4 consecutive days per week during 3 consecutive weeks * 5 next months: 4 consecutive days per month at monthly intervals
DRUGPlacebo
Oral administration - During 6 months : 1 sachet per day in the morning on an empty stomach * First month: 4 consecutive days per week during 3 consecutive weeks * 5 next months: 4 consecutive days per month at monthly intervals
Sponsors
Pierre Fabre Medicament
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 4 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Patients with all the following criteria will be eligible for inclusion in Year 1: * Children, male or female * Aged 3 to 4 years * Children known for recurrent URTIs in the past year (based on medical recording or reported history) * Children at risk for URTI in the physician's opinion (e.g. absence of breastfeeding, hospitalization in the previous year, tonsillectomy or adenoidectomy, parental smoking, daycare institution or nursery school, early schooling, prematurity, low weight at birth, malnutrition, failure to thrive). Patients with all the following criteria will be eligible for randomisation in Year 2: * Children, male or female * Aged 4 to 5 years * Suffering from RURTI, i.e. at least 6 URTI episodes medically confirmed, with a maximum of 18, during the Year 1 of the study. Key
Exclusion criteria
Presence of diseases (Chronic suppurative otitis media, acute broncho-pulmonary infection, Immune deficiency or disorders, surgery of respiratory tract, cystic fibrosis…) or treatments (chronic use of corticosteroids, bronchodilators, ...) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Upper-Respiratory Tract Infections (URTI) episodes medically assessed over year 2 | at each infectious episode over year 2 | Each URTI episodes will be medically assessed by the investigator by a thorough medical examination. |
Countries
Italy, Lithuania, Poland, Romania, Russia
Outcome results
None listed