Condition category
Ear, Nose and Throat
Date applied
13/10/2015
Date assigned
14/10/2015
Last edited
13/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic suppurative otitis media (CSOM) is a long-lasting infection of the middle ear. The middle ear, also known as the tympanic cavity, is the name given to the air-filled space directly behind the ear drum. In CSOM, an infection leads to long-lasting irritation of this area causing pus to continually drain from the ear (suppuration) and even hearing loss in the affected ear. The first line treatment for CSOM is the use of antibiotics, which work to fight the infection. When antibiotics are used a lot, bacteria can become resistant to their effects, which make them much more difficult to treat. OP-145 is a new product which has been shown to be effective against harmful microorganisms and to reduce inflammation. The aim of this study is to find out whether OP-145-containing ear drops are an effective and safe treatment for CSOM in adults.

Who can participate?
Adults with chronic suppurative otitis media which is resistant to antibiotic treatment.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given OP-145 ear drops to use twice a day for two weeks. Those in the second group are given placebo (inactive medication) ear drops to use twice a day for two weeks. Participants in both groups are asked to attend a clinic at the start of the study and then again after 1, 2, 4, 8 and 12 weeks so that their ears can be examined to find out whether the ear drops have helped with treatment or have had any unwanted side effects.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Leiden University Medical Center (lead center) and six other medical centres in the Netherlands.

When is the study starting and how long is it expected to run for?
September 2006 to July 2007

Who is funding the study?
OctoPlus BV (Netherlands)

Who is the main contact?
1. Dr Peter Nibbering (Scientific)
2. Dr Nanno Peek (Scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Nibbering

ORCID ID

http://orcid.org/0000-0002-0432-8340

Contact details

Leiden University Medical Center
Dept. of Infectious Diseases
Leiden
2300 rc
Netherlands

Type

Scientific

Additional contact

Dr Nanno Peek

ORCID ID

Contact details

Reinier de Graaf Hospital
Reinier de Graafweg 5
Delft
2625 ad
Netherlands
+31 15 2603060
f.peek@dgg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P02.216

Study information

Scientific title

Treatment of chronic suppurative otitis media with the antimicrobial peptide OP-145 (AMP60.4Ac) in adults

Acronym

Study hypothesis

The aim of this study is to investigate the safety and efficacy of ear drops containing OP-145 in adults with chronic suppurative otitis media (CSOM).

Ethics approval

Independent Ethics Committee of the Leiden University Medical Center, 20/06/2008, ref: P02-216

Study design

Randomized double-blind placebo-controlled multi-centre phase 2 study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic suppurative otitis media (CSOM)

Intervention

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 which do not contain OP-145. Participants are asked to apply a few drops (± 100 μl) directly on the tympanic membrane, twice daily for 2 weeks, followed by 10 weeks follow-up.

Intervention type

Drug

Phase

Drug names

OP-145

Primary outcome measures

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

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.

Overall trial start date

19/09/2006

Overall trial end date

04/07/2008

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

52 subjects

Participant 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

Recruitment start date

19/09/2006

Recruitment end date

15/04/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center
Dept ENT Albinusdreef 2
Leiden
2333 ZA
Netherlands

Trial participating centre

Erasmus Medical Center
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Trial participating centre

VU University Medical Center
De Boelelaan 1118
Amsterdam
1081 HZ
Netherlands

Trial participating centre

West Frieze Hospital (Westfriesgasthuis)
Maelsonstraat 3
Hoorn
1624 NP
Netherlands

Trial participating centre

Alkmaar Medical Center
Wilhelminalaan 12
Alkmaar
1815 JCL
Netherlands

Trial participating centre

St. Elisabeth Hospital
Hilvarenbeekse Weg 60
Tilburg
5022 GC
Netherlands

Trial participating centre

Wilhelmina Hospital
Europaweg-Zuid 1
Assen
9401 RK
Netherlands

Sponsor information

Organisation

OctoPlus BV

Sponsor details

Zernikedreef 12
Leiden
2333cl
Netherlands
+31 71 5244044
verrijk@octoplus.nl

Sponsor type

Industry

Website

www.octoplus.nl

Funders

Funder type

Industry

Funder name

OctoPlus BV

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A poster (L1-3337) on the results of this study has been presented at ICAAC 2009.
In addition, publication an open-access international journal is planned as soon as possible.

Intention to publish date

01/12/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes