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

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.

Completed

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Key information

Conditions

Recurrent Upper-Respiratory Tract Infections Common Cold Ear Diseases Infections Laryngeal Diseases Laryngitis Otitis Otitis Media Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases Tonsillitis Virus Diseases

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ancona, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

J022X ST

Drug

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

Placebo

Drug

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

Primary outcomes

Number of Upper-Respiratory Tract Infections (URTI) episodes medically assessed over year 2

Time frame: at each infectious episode over year 2

Each URTI episodes will be medically assessed by the investigator by a thorough medical examination.

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Sep 24, 2013
Registry last updated: Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed