Clinical efficacy and safety of J022X ST in the prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) in children with a high risk of recurrence

Phase 1

Conditions: Recurrent Upper-Respiratory Tract Infections (RURTI)
MedDRA version: 17.0Level: PTClassification code 10046306Term: Upper respiratory tract infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2013-001760-31-LT

Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

Inclusion Criteria

Inclusion criteria in Year 1
Patients with all the following criteria will be eligible for inclusion in Year 1:
Demographic Characteristics and Other Baseline Characteristics:
- Children, male or female
- Aged 3 to 4 years
The patients who are included have to be aged from 4 to 5 years between September to October of the randomisation year.
Diagnostic Criteria :
- 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).
Ethical / legal considerations:
- Children whose parent(s) or guardian(s) has (have) given his/her (their) written consent for the child's participation in the study, according to national regulations.
- Children whose parent(s) or guardian(s) is (are) cooperative with regard to compliance with study-related constraints.
- Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation)

Inclusion criteria in Year 2
Patients with all the following criteria will be eligible for randomisation in Year 2:
Demographic Characteristics and Other Baseline Characteristics:
- Children, male or female
- Aged 4 to 5 years
Diagnostic Criteria:
- Suffering from RURTI, i.e. at least 6 URTI episodes medically confirmed, with a maximum of 18, during the Year 1 of the study.
Ethical / legal considerations:
- Children whose parent(s) or guardian(s) has (have) confirmed his/her (their) written consent for the child's participation in the study, according to national regulations.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1000
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Other diseases:
- Foreign body, nasal tumor, anatomic abnormality such as palatine groove
- Previous major surgery in the respiratory tract (not included tonsillectomy or adenectomy) like cleft lip, palate, nasal surgeries etc. or anatomical damage to the respiratory tract due to tube insertion.
- Chronic suppurative otitis media.
- Known allergic rhinitis from patient’s medical history/records not controlled by standard therapy.
- Acute broncho-pulmonary infection (bronchiolitis. pneumonia, tuberculosis).
- Chronic broncho-pulmonary disorders such as active asthma needing a continuous use of steroids (oral/inhalers) ) (i.e. persistent forms in accordance with GINA classification) or bronchiectasis regularly treated with corticosteroids.
- Cystic fibrosis, primary abnormalities of mucociliary clearance (for example Kartagener's syndrome).
- Medically ongoing treatment for gastro-oesophageal reflux.
- Known HIV infection or any type of iatrogenic or congenital immune deficiency (including IgA deficiency).
- Auto-immune disease (e.g. nephropathy, insulin-dependent diabetes mellitus, rheumatoid purpura, juvenile idiopathic arthritis).
- Congenital heart disease (unresolved with ongoing medical symptoms) and severe haematologic diseases (except mild anemia without need for treatment).
- Cancer.
- Known a-1 anti-trypsin deficiency from patient’s medical history/records.
- Under-nourished children and children with backwardness of growth (<80% of the average weight for the age).
Relating to treatments:
- Medical history of hypersensitivity to J022X ST or any drug excipients
- Any on-going specific or non-specific immunotherapy with pharmacological effects on the immune system (including homeopathic or phytotherapy) whatever the route of administration, 3 months prior to inclusion and/or planned during the course of the study, except regular vaccinations.
- Chronic use of corticosteroids (over 2 consecutive weeks for maintenance therapy): intravenous, intramuscular, oral, inhaled, nasal, auricular or ocular solution.
- Chronic use of bronchodilators (over 2 consecutive weeks for maintenance therapy)
- Treatment with antileukotriens
- Any homeopathic or phytotherapy treatment (except for acute flare up but not over 2 consecutive weeks)
Others:
- Is a family member of the Investigator or any associate, colleague, and employee assisting in the conduct of the study (secretary, nurse, technician,…)
- Is participating or has participated in another clinical trial within the last month, has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial
- Concomitant participation of another sibling in the same family.
- Uncooperative parents (or guardians) expected difficulties in obtaining signature of one (both) parent(s) (or guardians), in follow-up or compliance.
- One (both) parent(s) (or guardians) or patient who, in the judgment of the investigator, is/are not likely to be compliant during the study.
- One (both) parent(s) (or guardians) who, in the judgment of the investigator, is/are mentally unable to understand the nature, objectives and possible consequences of the trial.
- One (both) parent(s) (or guardians) who has (have) forfeited his/her (their) freedom by administrative or legal award, or that is/are under guardianship.
- Parent(s) (or guardians) who cannot be contacted in case of emergency.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the clinical efficacy of J022X ST in preventing RURTI in young children at risk.;Secondary Objective: To evaluate the consequences of URTI on absenteeism (children and parents),<br>hospitalisation, use of other treatments for children<br>To evaluate the ENT and broncho-pulmonary complications of URTI<br>To document the safety of J022X ST;Primary end point(s): Number of URTI episodes medically assessed over year 2;Timepoint(s) of evaluation of this end point: For primary statistical analysis criterion evaluated over 12 months

Secondary Outcome Measures

Name	Time	Method

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