CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study

Phase 3

Completed

• Conditions: Recurrent Upper-Respiratory Tract Infections
• Interventions: Drug: J022X ST; Drug: Placebo

• Registration Number: NCT01948856
• Lead Sponsor: Pierre Fabre Medicament

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-24
• Primary Completion: 2016-10-17
• Study Completion: 2016-12-13
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1003

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
J022X ST	J022X ST	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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.