E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent Upper-Respiratory Tract Infections (RURTI) |
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E.1.1.1 | Medical condition in easily understood language |
Recurrent common cold, laryngitis, pharyngitis/tonsillitis, acute rhinitis, acute rhinosinusitis, and acute otitis media (AOM). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10046306 |
E.1.2 | Term | Upper respiratory tract infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the clinical efficacy of J022X ST in preventing RURTI in young children at risk. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the consequences of URTI on absenteeism (children and parents), hospitalisation, use of other treatments for children To evaluate the ENT and broncho-pulmonary complications of URTI To document the safety of J022X ST |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 α-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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of URTI episodes medically assessed over year 2 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
For primary statistical analysis criterion evaluated over 12 months |
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E.5.2 | Secondary end point(s) |
- Severe URTI: number of occurrences, mean number of days per child, percentage of children with at least one event, percentage of events - Hospitalisation caused by URTI: number of occurrences, mean number of days per child, percentage of children with at least one event, percentage of events. - Broncho-pulmonary infections: number of occurrences, mean number of days per child, percentage of children with at least one event, percentage of events. - Otitis media: number of occurrences, mean number of days per child, percentage of children with at least one event, percentage of events. - Clinical signs of asthma: number of occurrences, mean number of days per child, percentage of children with at least one event, percentage of events. - Antibiotics, NSAIDs and/or corticoids for URTI: number of occurrences, mean number of days per child, percentage of children with at least one event. - Absenteeism from daycare institutions/nursery school for the child: number of occurrences, mean number of days per child, percentage of children with at least one event. - Absenteeism from work for parent(s): number of occurrences, mean number of days per child, percentage of children whose parents have at least one event. - Time to first URTI episode - Quality of life (PAR-ENT QoL) - Safety of J022X ST: number and type of adverse events |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During year 1: evaluation criteria collected at D1, extra-visits at each URTI episode, month 12 except for Quality of life (PAR-ENT QoL) that is collected at only month 12
During year 2:evaluation criteria collected at D1, extra-visits at each URTI episode, Month 3, Month 6, Month 9 and month 12 except for Quality of life (PAR-ENT QoL) that is collected at D1, Month 3, Month 6, Month 9 and month 12
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |