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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).

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512937-34-00
Acronym
BUC-01-23
Enrollment
216
Registered
2024-10-17
Start date
2025-08-06
Completion date
Unknown
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RECURRENT LOWER RESPIRATORY TRACT INFECTIONS (RLRTIS).

Brief summary

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

Detailed description

Reduction in the number of infection episodes during 3, 6 and 9 months of treatment will be assessed., Mean duration in days per RLRTI during the Treatment period and during the Follow up period will be assessed., Number of antibiotic treatments for a respiratory event during the Treatment period and during the Follow-up period will be assessed., Number of sick days for patients or caregiver during the Treatment period and during the Follow-up period will be assessed., 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)., Quantitative and Qualitative Evaluation of Safety in terms of adverse events reported.

Interventions

DRUGPlacebo (Seven gastro-resistant tablets containing only excipients): Lactose
DRUGmicrocrystalline cellulose
DRUGcolloidal anhydrous silica
DRUGmagnesium stearate
DRUGeudragit L 100-55
DRUGsodium hydroxide
DRUGtalc
DRUGtriethyl citrate
DRUGtitanium dioxide
DRUGiron oxide red
DRUGiron oxide yellow
DRUGiron oxide black
DRUGopaglos.
DRUGBuccalin Adulti compresse gastroresistenti

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
Reduction in the number of infection episodes during 3, 6 and 9 months of treatment will be assessed., Mean duration in days per RLRTI during the Treatment period and during the Follow up period will be assessed., Number of antibiotic treatments for a respiratory event during the Treatment period and during the Follow-up period will be assessed., Number of sick days for patients or caregiver during the Treatment period and during the Follow-up period will be assessed., 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)., Quantitative and Qualitative Evaluation of Safety in terms of adverse events reported.—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026