A pharmacological study on efficacy and safety of OM-85 in children with recurrent respiratory tract infections
- Conditions
- Recurrent Respiratory Tract InfectionMedDRA version: 20.1Level: LLTClassification code 10039249Term: RTISystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-002705-19-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 288
Provision of written informed consent from parents/legal guardian prior to any study procedures
Preschool children of both gender, aged 1 to 6 years
Six or more acute respiratory tract illnesses in the previous year or 4 episodes of infectious bronchospasm (according to medical records from outpatient clinics)
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Anatomic alterations of the respiratory tract
Other chronic respiratory diseases (i.e., persistent wheezing requiring stable therapy with inhalatory steroids, tuberculosis or cystic fibrosis)
Severe primary immunodeficiency or HIV infection
Any autoimmune disease
Liver or kidney failure
Malnutrition
Any known neoplasia or malignancy
Treatment with the following medications: Antibiotics, systemic, inhaled or oral steroids (e.g., oral prednisolone) within 4 weeks before Visit 1, oral vaccination with live vaccine within 4 weeks before Visit 1, long-term azithromycin therapy within 3 months before Visit 1, previous and/or concomitant immunosuppressants, Immunostimulants, gamma globulins, or anticonvulsive drugs therapy within 6 months before Visit 1
Any major surgery within the last 3 months prior to study enrolment
Known allergy or previous intolerance to study medication or to any components/excipients of the study medication;
Severe immunodeficiency.
Any other clinical conditions, in the opinion of the investigator, that would not allow safe completion of the clinical study
Parents/legal guardians not willing or unable to give written informed consent
Participant's families may not be expected to relocate out of study area within 1 year of the initiation of the study
Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or receiving other investigational agent(s).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method