EUCTR2016-002705-19-IT
Active, not recruiting
Phase 1
A phase IV, randomized, controlled, double-blind study on efficacy and safety of OM-85 in children with recurrent respiratory tract infections - OMPeR
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO0 sites288 target enrollmentJanuary 22, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
- Enrollment
- 288
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Not specified
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