Randomized, Double Blind, Placebo Controlled, Two-Arms, Multicenter, Post Authorization Efficacy and Safety Study (Paes) to Confirm and Collect More Clinical Data of Buccalin® Tablets in the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIs).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratorio Farmaceutico S.I.T. - Specialita' Igienico Terapeutiche S.r.l.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

6 Aug 2025 → ongoing

Decision date (initial)

2024-10-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512937-34-00

WHO UTN

U1111-1308-7652

ClinicalTrials.gov

NCT06736288

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To confirm and collect more clinical data of Buccalin tablets in the prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIs).

Conditions and MedDRA coding

RECURRENT LOWER RESPIRATORY TRACT INFECTIONS (RLRTIS).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients willing and able to provide voluntary informed consent and to follow protocol requirements.
2. Male or females from 18 to 99 years old, (Adult, Older Adult)
3. Patients with Recurrent LRTIs including tracheitis, tracheobronchitis, acute bronchitis and exacerbations of chronic lung disease (asthma and/or COPD and/or bronchiectasis), who present with both of the following: a. ≥2 episodes within 12 months prior to the run-in period based on patient reported medical history (to access the run-in period) b. ≥2 episodes during the run-in period documented by appropriate microbiological diagnostic test (to access the treatment period)
4. Patients: a. Not vaccinated Or b. Vaccinated against the most common pathogens for respiratory infection (within 12 months prior to the run-in period or during the run-in period, but not during the treatment period): - Anti-pertussis vaccination - Covid-19 vaccination - Respiratory Syncytial Virus vaccination - Influenza vaccination - Pneumococcal vaccination

Exclusion criteria 19

1. Female patient: pregnant, lactating or planning pregnancy (Female of child-bearing potential will undergo urine pregnancy test).
2. History of known liver damages defined by the METAVIR classification (F1-F4).
3. Malignancies with a remission period of < 5 years.
4. Injection or oral administration of steroids within 4 weeks prior to randomization.
5. Use of immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to randomization.
6. Previous use within 6 months prior to randomization or ongoing use of bacterial lysates.
7. Any major surgery within the last 3 months prior to randomization.
8. Wheezing documented to be caused by gastroesophageal reflux.
9. Patient legally or mentally incapacitated unable to give informed consent for the participation in this study.
10. Patient who is unable or unwilling to comply with the appointments or with all the requirements of the Protocol.
11. Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.
12. Contraindication or known hypersensitivity to the active ingredients of bacterial lysates or any excipients listed in the ingredients.
13. Pneumonia (based on the EMA Referral Procedure EMEA/H/A-31/1465).
14. Known history of tuberculosis and/or cystic fibrosis.
15. Known history of immunodeficiency diseases (e.g., HIV infection, AIDS, or any type of congenital or iatrogenic immune deficiency, including IgA deficiency).
16. Severe heart failure (NYHA class III and IV).
17. Haematologic diseases including severe anaemia (defined according to the National Cancer Institute as Hemoglobin < 8.0 g/dL).
18. Renal failure (eGFR < 30 mL/min).
19. History of autoimmune diseases and acute intestinal infections, as reported in Buccalin® SmPC.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Reduction in the number of infection episodes in the treatment period (12 months) in the Buccalin® group versus the Placebo group.

Secondary endpoints 6

1. Reduction in the number of infection episodes during 3, 6 and 9 months of treatment will be assessed.
2. Mean duration in days per RLRTI during the Treatment period and during the Follow up period will be assessed.
3. Number of antibiotic treatments for a respiratory event during the Treatment period and during the Follow-up period will be assessed.
4. Number of sick days for patients or caregiver during the Treatment period and during the Follow-up period will be assessed.
5. During the treatment period the patients were asked to fill in a Visual Analogue Scale (VAS) ranging from 0 (the worse) to 10 (the best situation).
6. Quantitative and Qualitative Evaluation of Safety in terms of adverse events reported.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratorio Farmaceutico S.I.T. - Specialita' Igienico Terapeutiche S.r.l.

Sponsor organisation

Laboratorio Farmaceutico S.I.T. - Specialita' Igienico Terapeutiche S.r.l.

Address

Via Camillo Benso Conte Di Cavour 70

City

Mede

Postcode

27035

Country

Italy

Scientific contact point

Organisation

Laboratorio Farmaceutico S.I.T. - Specialita' Igienico Terapeutiche S.r.l.

Contact name

Silvana Lonetti

Public contact point

Organisation

Laboratorio Farmaceutico S.I.T. - Specialita' Igienico Terapeutiche S.r.l.

Contact name

Silvana Lonetti

Third parties 1

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications