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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).
EU CTIS ID: 2024-512937-34-00
What this study is testing
To confirm and collect more clinical data of Buccalin tablets in the prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIs).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients willing and able to provide voluntary informed consent and to follow protocol requirements.
- Male or females from 18 to 99 years old, (Adult, Older Adult)
- 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)
- 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
You likely can't join if
- Female patient: pregnant, lactating or planning pregnancy (Female of child-bearing potential will undergo urine pregnancy test).
- Patient who is unable or unwilling to comply with the appointments or with all the requirements of the Protocol.
- Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.
- Contraindication or known hypersensitivity to the active ingredients of bacterial lysates or any excipients listed in the ingredients.
- Pneumonia (based on the EMA Referral Procedure EMEA/H/A-31/1465).
- Known history of tuberculosis and/or cystic fibrosis.
See the full eligibility criteria
Who can join
- Patients willing and able to provide voluntary informed consent and to follow protocol requirements.
- Male or females from 18 to 99 years old, (Adult, Older Adult)
- 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)
- 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
What rules you out
- Female patient: pregnant, lactating or planning pregnancy (Female of child-bearing potential will undergo urine pregnancy test).
- Patient who is unable or unwilling to comply with the appointments or with all the requirements of the Protocol.
- Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.
- Contraindication or known hypersensitivity to the active ingredients of bacterial lysates or any excipients listed in the ingredients.
- Pneumonia (based on the EMA Referral Procedure EMEA/H/A-31/1465).
- Known history of tuberculosis and/or cystic fibrosis.
- Known history of immunodeficiency diseases (e.g., HIV infection, AIDS, or any type of congenital or iatrogenic immune deficiency, including IgA deficiency).
- Severe heart failure (NYHA class III and IV).
- Haematologic diseases including severe anaemia (defined according to the National Cancer Institute as Hemoglobin < 8.0 g/dL).
- Renal failure (eGFR < 30 mL/min).
- History of autoimmune diseases and acute intestinal infections, as reported in Buccalin® SmPC.
- History of known liver damages defined by the METAVIR classification (F1-F4).
- Malignancies with a remission period of < 5 years.
- Injection or oral administration of steroids within 4 weeks prior to randomization.
- Use of immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to randomization.
- Previous use within 6 months prior to randomization or ongoing use of bacterial lysates.
- Any major surgery within the last 3 months prior to randomization.
- Wheezing documented to be caused by gastroesophageal reflux.
- Patient legally or mentally incapacitated unable to give informed consent for the participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- North Macedonia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include North Macedonia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.