Otitis ExternaNCT05370209
Performance and Safety of Otinova® Ear Spray
A study testing Otinova® Ear Spray in people with Otitis Externa, run by Circius Pharma AB at 3 sites in Sweden.
Trial summary
The purpose of this study is to assess the performance and safety of Otinova® Ear Spray when used in the treatment of external otitis symptoms. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Otitis Externa
- What is being tested?
- Otinova® Ear Spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesSweden
- Study dates
- 1 May 2022to 29 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female ≥ 5 years old
- Clinical diagnosis of otitis externa based on otoscopic exam:
- a.Defined as a clinical score of at least 1, on a scale from 0 to 2 (none, mild/moderate, severe), for at least one of the OE signs (swelling, erythema and otorrhea)
- Ability to correctly administer Otinova as spray (not requiring tamponade), as judged by the Investigator
- Subject agrees to refrain from water immersion of the ears during the investigation
- Subject agrees to refrain from using other ear treatment products during the investigation
- For pediatric patients, provision of informed consent by subject and legal -Subject, and if applicable legal representative(s), are willing to comply with the protocol and attend all investigation visits.
Who cannot join
- Duration of OE signs/symptoms longer than 6 weeks
- Suspected perforated eardrum or eardrum fitted with drainage tube
- Post-mastoid surgery
- Prior otologic surgery within 6 months of enrollment (must be successfully healed)
- Conditions which may make it difficult to evaluate the therapeutic response (e.g malignant OE, abscess, granulation, polyps, congenital disorders)
- History of malignant tumors in the external ear canal, or currently receiving chemotherapy or radiation therapy
Show all 11Show fewer
- Known allergy or sensitivity to any component of the device
- Use of topical or systemic antibiotics, corticosteroids or other treatment that could affect the study result within 7 days prior to enrolment
- Pregnancy or lactation at time of enrolment
- Subjects with any other condition that, as judged by the investigator, may make investigation procedures inappropriate
- Participation in another clinical investigation within 30 days of screening
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Carlanderska sjukhuset
Gothenburg
Cordinator Medical Service AB
Linköping
Öron-Näsa-Hals-Center Malmö
Malmö
About this study
Official title: A Prospective, Post-Market Clinical Follow-up Investigation to Verify Performance and Safety of Otinova® Ear Spray When Used in the Treatment of External Otitis Symptoms
The purpose of this study is to assess the performance and safety of Otinova® Ear Spray when used in the treatment of external otitis symptoms.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will receive treatment with Otinova® Ear Spray for 7 days, twice daily.
- Conditions
- Otitis Externa
- Being tested
- Otinova® Ear Spray
- Medical subject headings
- Otitis Externa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otinova® Ear SprayDevice
Ear spray
| Study group | Role | What they receive |
|---|---|---|
| Otinova® Ear Spray | Experimental | Otinova® Ear Spray 1-2 sprays, twice daily for 7 days Receives: Device: Otinova® Ear Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea
Proportion of subjects who have all signs of swelling, erythema and otorrhea scored as 0 on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) on Day 7
Measured: Day 7
Secondary outcomes (8)
Change in Clinical Symptoms Itching, Otalgia and Tenderness
Change in clinical symptoms itching, otalgia and tenderness, from Day 1 to Day 7, based on subject reported outcomes, using a score from 0 to 4, where 0 = no symptoms, 1= Mild, 2 = Moderate, 3= Severe and 4 = Very Severe
Measured: Change from Baseline (Day 1) to Day 7
Change in Microbes in the Earcanal
Change of pathologic microbes in the ear canal from baseline (Day 1) to Day 7.
Measured: Change from Baseline (Day 1) to Day 7
Change of Moisture in the Earcanal
Proportion of subjects who have signs of otorrhea (moisture) at baseline (Day 1)on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) and show an improvement of 1 or more points at Day 7.
Measured: Change from Baseline (Day 1) to Day 7
Change in Volume of Ear Canal
Proportion of subjects who have signs of swelling at baseline (Day 1) on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) and show an improvement of 1 or more points at Day 7.
Measured: Change from Baseline (Day 1) to Day 7
User Handling
Questionnaire regarding User handling - "How did you experience the use of the earspray?" and "Was it easy to apply the spray correctly in the ear?" using a 5-point scale: 1=very easy to use, 2=easy to use, 3=neither easy nor difficult to use, 4=difficult to use, 5=very difficult to use
Measured: Day 7
Change in Sleep
Proportion of subjects with less sleep disruption Day 7 compared to baseline (Day 1), as reported in subject diary
Measured: Change from Baseline (Day 1) to Day 7
Chnage in Pain Relief Medication Use
Proportion of subjects with less use of pain relief medication for ear pain on Day 7 compared to baseline (Day 1), as reported in subject diary
Measured: Change from Baseline (Day 1) to Day 7
Antibiotic Use
Use of antibiotics for OE symptoms at Day 7
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 May 2022
- Primary completion27 Nov 2023
- Study completion29 Jan 2024
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Otitis ExternaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circius Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Wilhelms, MD, PhD, Principal investigator, Cordinator Medical Service ABSarah Ohlsson Maleki, MD, Principal investigator, Öron-Näsa-Hals-Center Malmö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370209
- Sponsor's protocol ID
- CIR_001
- Status last verified
- Sep 2024
- First submitted
- 3 May 2022
- Last updated
- 15 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-Market Clinical Follow-up Investigation to Verify Performance and Safety of Otinova® Ear Spray When Used in the Treatment of External Otitis Symptoms
- ClinicalTrials.gov ID
- NCT05370209
- Acronym / sponsor ID
- CIR_001
- Conditions
- Otitis Externa
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Circius Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Posted 15 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the performance and safety of Otinova® Ear Spray when used in the treatment of external otitis symptoms.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will receive treatment with Otinova® Ear Spray for 7 days, twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Otinova® Ear Spray | Experimental | Device: Otinova® Ear SprayOtinova® Ear Spray 1-2 sprays, twice daily for 7 days |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥ 5 years old
- Clinical diagnosis of otitis externa based on otoscopic exam:
- a.Defined as a clinical score of at least 1, on a scale from 0 to 2 (none, mild/moderate, severe), for at least one of the OE signs (swelling, erythema and otorrhea)
- Ability to correctly administer Otinova as spray (not requiring tamponade), as judged by the Investigator
- Subject agrees to refrain from water immersion of the ears during the investigation
Key exclusion criteria (11 listed)
- Duration of OE signs/symptoms longer than 6 weeks
- Suspected perforated eardrum or eardrum fitted with drainage tube
- Post-mastoid surgery
- Prior otologic surgery within 6 months of enrollment (must be successfully healed)
- Conditions which may make it difficult to evaluate the therapeutic response (e.g malignant OE, abscess, granulation, polyps, congenital disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Otinova® Ear SprayEar spray | Device | Otinova® Ear Spray |
Primary outcome
Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea
Time frame: Day 7
Proportion of subjects who have all signs of swelling, erythema and otorrhea scored as 0 on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) on Day 7
8 secondary outcomes
Change in Clinical Symptoms Itching, Otalgia and Tenderness
Time frame: Change from Baseline (Day 1) to Day 7
Change in Microbes in the Earcanal
Time frame: Change from Baseline (Day 1) to Day 7
Change of Moisture in the Earcanal
Time frame: Change from Baseline (Day 1) to Day 7
Change in Volume of Ear Canal
Time frame: Change from Baseline (Day 1) to Day 7
User Handling
Time frame: Day 7
Change in Sleep
Time frame: Change from Baseline (Day 1) to Day 7
Chnage in Pain Relief Medication Use
Time frame: Change from Baseline (Day 1) to Day 7
Antibiotic Use
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Wilhelms, MD, PhD principal investigator
Cordinator Medical Service AB
Sarah Ohlsson Maleki, MD principal investigator
Öron-Näsa-Hals-Center Malmö
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otinova® Ear Spray in people with Otitis Externa, run by Circius Pharma AB at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.