Treatment of chronic suppurative otitis media with the antimicrobial peptide OP-145 (AMP60.4Ac) in adults
- Conditions
- Chronic suppurative otitis media (CSOM)Ear, Nose and Throat
- Registration Number
- ISRCTN12149720
- Lead Sponsor
- OctoPlus BV
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32287316/ (added 12/05/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method <br> 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.<br> 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.<br>