Chronic suppurative otitis media (CSOM) Ear, Nose and Throat Chronic suppurative otitis media (CSOM)
Conditions
Interventions
Participants are randomly allocated to one of two groups. The first group receive the OP-145, reconstituted in eardrops at a concentration of 0.5 mg/ml, and the second group receive control ear drops
Sponsors
OctoPlus BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Legally competent, no psychiatric history 3. Diagnosis of CSOM with chronic proliferative mucosal changes > 6 months 4. A clear perforation of the tympanic membrane to allow proper inspection of the middle ear mucosa 5. Antibiotic therapy resistant (having received adequate treatment for CSOM for at least 2 periods of in total = 6 weeks within the past year with at least two different ear drops and the last treatment period having occurred within the last 6 months before screening)
Exclusion criteria
Exclusion criteria: 1. Cholesteatoma in the ear to be treated (i.e. CSOM with cholesteatoma) 2. Presence of a radical cavity in the ear to be treated 3. Use of systemic immune suppressants or antibiotics, use of topical antibiotics, corticosteroids or other eardrops in one of the ears until 4 weeks before study start 4. Down’s syndrome or other congenital anomalies to the external or middle ear or to the area of the “Eustachian tube – middle ear” of the ear to be treated 5. Presence of immune disorders, e.g. primary immune deficiency, immune proliferative disorders, Multiple Sclerosis, Crohn’s Disease, rheumatoid arthritis or Primary Ciliary Dyskinesia 6. Severe dizziness or severe headache, impacting on subjects’ daily life activities 7. Facialis nerve disorders on the side of the ear to be treated 8. Pregnancy, the wish to become pregnant or to breastfeed during the study, or, in case of a male subject, the wish to make his partner pregnant during the study 9. Prior participation in the dose-finding study of the program
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the OP-145 was determined by recording adverse effects and concomitant medication, laboratory tests (specific peptide antibodies and general hematology), swabs from the middle ear and throat for bacterial culture and audiometry (including high pitch audiometry) at baseline 1, 2, 4, 8 and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy of the OP-145 in inducing improvement in the mucosa of the middle ear of adults with CSOM is measured by otoscopic inspections at baseline 1, 2, 4, 8 and 12 weeks. 2. Quality of life is determined using he SF-36, the chronic ear survey (CES) and the Brief Illness Perception Questionnaire (IPQ-b) at baseline 1, 2, 4, 8 and 12 weeks. | — |
Countries
Netherlands
Outcome results
None listed