Study on Buccalin for Preventing Recurrent Lower Respiratory Infections in Adults

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
ASST Fatebenefratelli Sacco	Milan	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
Aexizhf Ocesskdwgsf Nnmlmlrih Su Ajmjxeh E Bhpmtc E C Arqvhg Aegnrksvxgj	Alexandria	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.07.2025

Trial locations

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.

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 ID:

2024-512937-34-00

Protocol code:

BUC-01-23

NCT ID:

NCT06736288

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Buccalin for Preventing Recurrent Lower Respiratory Infections in Adults

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