Randomized, prospective double-blind placebo controlled study for the evaluation of the number, duration and severity of Upper Respiratory Tract Infections in children with risk of recurrence after standard treatment with bacterial lysates Paspat 3 mg tablets, over an observation period of six months.

Phase 1

• Conditions: upper respiratory tract infections in children at high risk of reccurence.; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-000979-24-IT
• Lead Sponsor: Daiichi Sankyo Italia SpA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-10
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Patients with all the following criteria will be eligible for inclusion in the study protocol:
1. Male or female.
2. Aged 4 to 6 years achieved.
3. Patients with at least 6 URTI episodes confirmed by medical recording or reported history, with a maximum of 18, during the 12 months prior randomization.
4. Children whose parent(s) or guardian(s) has (have) who given their written consent for participation in the study.
5. Possibility to have regular telephone contacts with patient’s parent(s).
6. Patients, and their parents, who are supposed will be cooperative with regard to compliance with study-related constraints.

Are the trial subjects under 18? yes
Number of subjects for this age range: 210
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

1. Previous major surgery in the oral, nasal or respiratory tracts (except tonsillectomy or adenoidectomy) like cleft lip, palate, nasal surgeries etc. or anatomical damage to the respiratory tract due to intubation.
2. Anatomic abnormalities of oral, nasal or respiratory tracts.
3. Fever at the time of randomization.
4. Known allergic rhinitis from patient’s medical history/records not controlled by standard therapy.
5. Acute broncho-pulmonary infection (bronchiolitis. pneumonia, tuberculosis) at the time of randomization.
6. Chronic broncho-pulmonary disorders such as active asthma needing a continuous use of steroids (oral or inhalers) or bronchiectasis regularly treated with corticosteroids.
7. Oral, nasal or respiratory abscess, including also chronic suppurative otitis media.
8. Cystic fibrosis, primary abnormalities of mucociliary clearance (for example Kartagener's syndrome).
9. Known a-1 anti-trypsin deficiency from patient’s medical history/records.
10. Auto-immune disease (e.g. nephropathy, insulin-dependent diabetes mellitus, rheumatoid purpura, juvenile idiopathic arthritis).
11. Acute intestinal infections.
12. Severe systemic diseases, including Human Immunodeficiency Virus (HIV) infection, severe haematological diseases, cancer and otherwise severely compromised patients.
13. Medical history of hypersensitivity to Paspat 3 mg tablets or any drug excipients.
14. Any on-going specific or non-specific immunotherapy with pharmacological effects on the immune system (including homeopathic or phytotherapy) whatever route of administration, 3 months prior to inclusion and/or planned during the course of the study, except regular vaccinations.
15. Any homeopathic or phytotherapy treatment used for preventing recurrent infections or for improving immunity in the 6 months prior randomization.
16. Participation in another clinical trial at the time of the randomization or within 4 weeks before randomization.
17. Patient’s or family’s difficulties or problems, in the judgment of the investigator, in being compliant with study procedures and requirements, including social or mental constrains.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: week 4/ week 8/ week 12/week 16/ week 20/ week 28 (+ o - 1 week) after End of Treatment;Main Objective: To assess the clinical efficacy of Paspat 3 mg<br>tablets in preventing, number and severity of recurring infections of the upper respiratory tract in children at risk, testified by at least six<br>recurrences in the previous 12 months;Secondary Objective: To compare, active and placebo groups,<br>the duration of URTI .<br>To evaluate the consequences of URTIson loss of working days for parents or school days for children, hospitalisation and use of other treatments.<br>To document the safety of Paspat 3 mg tablets;Primary end point(s): Prevention in the number and severity of<br>recurring infections of the upper respiratory tract in children at risk, testified by at least six recurrences in the previous 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) To compare, in active and placebo<br>groups, the duration URTIs in adults.<br>2) To evaluate the consequences URTIs on loss of school days, hospitalisation and use of other<br>treatments.<br>3) To evaluate physical examination and adverse events.;Timepoint(s) of evaluation of this end point: week 4/ week 8/ week 12/week 16/ week 20/ week 28 (+ o - 1 week) after End of Treatment