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

Phase 1

• Conditions: Evaluation of clinical efficacy of Paspat 3 mg tablets in the prevention of number, duration and severity of Respiratory Tract Infections in adults with risk, defined as affected of at least 6 episodes in the previous 12 months.; MedDRA version: 20.1Level: LLTClassification code 10038133Term: Recurrent respiratory tract infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-000978-38-IT
• Lead Sponsor: DAIICHI SANKYO ITALIA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-02
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1.Male or female.
2.Aged 18 to 80 years achieved.
3.Patients with at least 6 RTI/LRTI or URTI episodes confirmed by medical recording or reported history, with a maximum of 18, during the 12 months prior randomization.
4.Patients who given their written consent for participation in the study.
5.Possibility to have regular telephone contacts with patient.
6.Patients who are supposed will be cooperative with regard to compliance with study-related constraints.

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Women with childbearing potential not using effective contraception (oral contraceptives, intrauterine device, tubal ligation or other efficient procedures).
2.Women referring, at the screening visit, to be pregnant or breast feeding or women likely to become pregnant during the time of the study.
3.Previous major surgery in the oral, nasal or respiratory tracts (except tonsillectomy or adenectomy) like cleft lip, palate, nasal surgeries etc. or anatomical damage to the respiratory tracts due to intubation
4.Anatomic abnormalities of oral, nasal or respiratory tracts.
5.Fever at the time of randomization.
6.Known allergic rhinitis from patient’s medical history/records not controlled by standard therapy.
7.Acute broncho-pulmonary infection (bronchiolitis, pneumonia, tuberculosis) at the time of randomization.
8.Chronic broncho-pulmonary disorders such as active asthma needing a continuous use of steroids (oral or inhalers) or bronchiectasis regularly treated with corticosteroids.
9.Oral, nasal or respiratory abscess, including also chronic suppurative otitis media.
10.Cystic fibrosis, primary abnormalities of mucociliary clearance (for example Kartagener's syndrome).
11.Known a-1 anti-trypsin deficiency from patient’s medical history/records.
12.Auto-immune disease (e.g. nephropathy, insulin-dependent diabetes mellitus, rheumatoid purpura, juvenile idiopathic arthritis).
13.Acute intestinal infections.
14.Severe systemic diseases, including Human Immunodeficiency Virus (HIV) infection, severe haematological diseases, cancer and otherwise severely compromised patients.
15.Medical history of hypersensitivity to Paspat 3 mg tablets or any drug excipients.
16.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.
17.Any homeopathic or phytotherapy treatment used for preventing recurrent infections or for improving immunity in the 6 months prior randomization.
18.Participation in another clinical trial at the time of the randomization or within 4 weeks before randomization.
19.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
Main Objective: To assess the clinical efficacy of Paspat 3 mg tablets in preventing, number and severity of recurring infections of the respiratory tract in adults at risk, testified by at least six recurrences in the previous 12 months;Secondary Objective: To compare, active and placebo groups, the duration of RTI/LRTI and URTI in adults.<br>To evaluate the consequences of RTI /LRTI and URTI on loss of working or school days, hospitalisation and use of other treatments.<br>To document the safety of Paspat 3 mg tablets<br>;Primary end point(s): Prevention in the number and severity of recurring infections of the respiratory tract in adults at risk, testified by at least six recurrences in the previous 12 months;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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) To compare, in active and placebo groups, the duration of RTI/LRTI and URTI in adults.<br>2) To evaluate the consequences of RTI/LRTI and URTI on loss of working or school days, hospitalisation and use of other treatments.<br>3) To evaluate physical examination and adverse events.<br>;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