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The Efficacy of Octenidine in Sinusitis compared to standard of care

The Efficacy of Octenidine in Sinusitis compared to standard of care

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
LBCTR
Registry ID
LBCTR2020023398
Enrollment
40
Registered
2020-02-20
Start date
2020-03-02
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bacterial Rhinosinusitis ARS is defined as symptomatic inflammation of the nasal cavity and paranasal sinuses that lasts less than four weeks. The most common etiology of ARS is viral

Interventions

Patients will be recruited from multiple departments: ENT, Family Medicine, Infectious Diseases and Emergency Medicine. After determining if the patient falls under the guidelines of ABRS or CRS exace
Intranasal application of Octenidine twice daily for ten days
The use of oral antibiotics for treatment of bacterial sinusitis (standard of care)
Group 1
Group 2

Sponsors

Schülke
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: ? CRS: Patients (male or female) at the age of 18 or above who fit the criteria for exacerbation in CRS : ? Twelve weeks or longer of two or more of the following signs and symptoms: o mucopurulent drainage (anterior, posterior, or both) o nasal obstruction (congestion) o facial pain-pressure-fullness o decreased sense of smell. ? AND inflammation is documented by one or more of the following findings: o purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region. o radiographic imaging showing inflammation of the paranasal sinuses. ? ABRS: Patients at the age of 18 or above who fit the criteria for ABRS

Exclusion criteria

Exclusion criteria: ? Exclusion criteria for both ABRS and CRS: o Patients who are below the age of 18. o Patients who are pregnant. o Patients who have received antibiotics. o Patients who are immunocompromised. o Patients who have high grade fever defined as 38.5C and above o Patients with known allergy to octenidine. o Patients with contraindications to octenidine. o Patients who scored severe on the SNOT22 score o Patients who are receiving systemic glucocorticoid therapy.

Design outcomes

Primary

MeasureTime frame
Name: Treatment of Rhinosinusitis;Timepoints: 10 days;Measure: change in SNOT22 score

Secondary

MeasureTime frame
Name: Decreasing the use of antibiotics, and hence decreasing the antimicrobial resistance on the long run;Timepoints: years;Measure: Antibiotic susceptibility profile of pathogens

Countries

Lebanon

Contacts

Public ContactHarout Kolanjian

LAUMC-RH

harout.kolanjian@lau.edu01 200 800

Outcome results

None listed

Source: LBCTR (via WHO ICTRP) · Data processed: Feb 7, 2026