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Study on Buccalin for Preventing Recurrent Lower Respiratory Infections in Adults

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a medication called Buccalin in preventing Recurrent Lower Respiratory Tract Infections (RLRTIs). These infections can include conditions like acute bronchitis and flare-ups of chronic lung diseases such as asthma and Chronic Obstructive Pulmonary Disease (COPD). The study will compare the effects of Buccalin with a placebo, which is a tablet that looks like the medication but does not contain any active ingredients.

The purpose of the study is to gather more information about how well Buccalin works in preventing these recurrent infections. Participants in the study will be randomly assigned to receive either Buccalin or the placebo. The study will last for 12 months, during which the number of infection episodes will be monitored and compared between the two groups. Additionally, the study will look at the duration of each infection, the number of antibiotic treatments needed, and the number of sick days experienced by participants.

Throughout the study, participants will be asked to fill out a simple scale to rate their health condition, ranging from 0 (the worst) to 10 (the best). The safety of Buccalin will also be evaluated by monitoring any side effects that occur. This study aims to provide valuable insights into the potential benefits of Buccalin for individuals who frequently experience lower respiratory tract infections.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide voluntary informed consent. This means you agree to participate and follow the study's requirements.

    You must be between 18 and 99 years old and have a history of recurrent lower respiratory tract infections (RLRTIs), which include conditions like acute bronchitis and exacerbations of chronic lung disease.

  2. Step 2

    Randomization

    You will be randomly assigned to one of two groups: one group will receive the Buccalin tablets, and the other will receive a placebo. A placebo is a tablet that looks like the real medication but does not contain the active substance.

  3. Step 3

    Treatment period

    During the treatment period, you will take the assigned tablets orally. The dosage, frequency, and duration of administration will be provided by the study team.

    The treatment period will last for 12 months. During this time, the study will monitor the number of infection episodes you experience.

  4. Step 4

    Regular assessments

    Throughout the study, you will have regular assessments to monitor your health and the effectiveness of the treatment.

    You will be asked to fill in a Visual Analogue Scale (VAS) to rate your condition from 0 (the worst) to 10 (the best).

  5. Step 5

    Follow-up period

    After the treatment period, there will be a follow-up period to continue monitoring your health and any changes in your condition.

    The study will assess the number of antibiotic treatments and sick days during this period.

  6. Step 6

    Completion of the study

    At the end of the study, the results will be analyzed to determine the effectiveness and safety of the Buccalin tablets in preventing recurrent lower respiratory tract infections.

    You will be informed about the overall findings of the study.

Who can join the trial?

5 criteria

  • Patients must be willing and able to provide voluntary informed consent and follow the study requirements.
  • Participants can be male or female and must be between 18 to 99 years old.
  • Patients must have a history of Recurrent Lower Respiratory Tract Infections (RLRTIs), which means having 2 or more episodes of respiratory infections within the last 12 months. This includes conditions like acute bronchitis and worsening of chronic lung diseases such as asthma, COPD (Chronic Obstructive Pulmonary Disease), or bronchiectasis.
  • Patients should not have received certain vaccinations, or if they have, it should be for: Anti-pertussis (whooping cough), Covid-19, Respiratory Syncytial Virus, Influenza (flu), or Pneumococcal (pneumonia).
  • The recurrent infections must be confirmed by appropriate microbiological tests.

Who cannot join the trial?

6 criteria

  • Patients who have a history of **allergic reactions** to any of the ingredients in the study medication cannot participate. An allergic reaction is when your body reacts badly to something, like a rash or trouble breathing.
  • Patients who are currently taking other medications that might interfere with the study medication are not eligible. This means if you are on certain drugs that could affect how the study medication works, you cannot join.
  • Patients with **serious health conditions** that could affect their safety during the study cannot participate. Serious health conditions are illnesses that can make you very sick or need a lot of medical care.
  • Patients who are pregnant or breastfeeding are not allowed to join the study. This is to ensure the safety of both the mother and the baby.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible. This is to make sure that the results of this study are not affected by other treatments.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate. This means if you cannot come to the appointments or do what the study asks, you cannot join.
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Investigated drugs

Buccalin is a type of tablet used in this clinical trial. It is designed to help prevent infections in the lower part of the lungs, which are called recurrent lower respiratory tract infections. These infections can happen often and make it hard to breathe. The goal of using Buccalin tablets in this study is to see how well they work in stopping these infections from coming back and to gather more information about their safety and effectiveness.

What is already known about the treatment

Buccalin – Buccalin is administered in tablet form and is taken orally. It is currently being studied in a clinical trial to gather more data on its effectiveness and safety for preventing recurrent lower respiratory tract infections (RLRTIs). The main therapeutic use of Buccalin is to help prevent these types of infections, which can be frequent and troublesome. At the molecular level, Buccalin works by stimulating the immune system to better defend against infections in the respiratory tract. It is classified pharmacologically as an immunostimulant, which means it helps boost the body's natural defense mechanisms.

Investigated diseases

Recurrent Lower Respiratory Tract Infections – Recurrent Lower Respiratory Tract Infections (RLRTIs) are characterized by repeated episodes of infections affecting the lower part of the respiratory system, which includes the trachea, bronchi, and lungs. These infections can lead to symptoms such as coughing, wheezing, shortness of breath, and chest discomfort. The progression of RLRTIs involves repeated cycles of infection and recovery, which can cause inflammation and damage to the respiratory tract over time. Factors contributing to the recurrence of these infections may include weakened immune function, environmental exposures, or underlying chronic respiratory conditions. The frequency and severity of episodes can vary among individuals, and the condition may require ongoing monitoring to manage symptoms and prevent complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512937-34-00Protocol codeBUC-01-23Estimated enrolment240 patientsSponsorLaboratorio Farmaceutico S.I.T. - Specialita' Igienico Terapeutiche S.r.l.

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