Subjects who need to undergo septoplasty, septorhinoplasty or functional endoscopic sinus surgery unrelated to this study.
Conditions
Interventions
Trade Name: Dymista®
Pharmaceutical Form: Nasal spray, suspension
INN or Proposed INN: AZELASTINE HYDROCHLORIDE
Other descriptive name: AZELASTINE HYDROCHLORIDE
Concentration unit: µg microgram(s)
Con
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients - Age: 18 – 70 years (included) - Subjects who need to undergo septoplasty, septorhinoplasty or functional endoscopic sinus surgery unrelated to this study - Willing and able to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: - Patients who are member of the staff or relatives thereof directly involved in the conduct of the protocol - Participant in any other trial during the last 30 days - Previous treatment with Dymista or any other topical corticosteroid spray or drops within the last month before the operation - Previous treatment with systemic corticosteroid in the last 2 months before operation - Previous treatment with anti-histaminics 7 days before operation - Pregnant or breast feeding women - Allergic for one of the compounds azelastinehydrochloride or fluticasonpropionate - Significant co-morbidity (for instance, but not limited to): • Glaucoma, cataracts, and increased intraocular pressure. • Subjects with active or quiescent tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex • Subjects with severe liver disease - Use of prohibited concomitant medication • Potent inhibitors of cytochrome P450 (CYP) 3A4 • Ritonavir - Patients unwilling or unable to attend the proposed visit schedule - Patients suspected or known not to be trustworthy or who are likely not to comply with the study directives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to investigate and to compare the bioavailability of MP29-02 and fluticasone propionate in nasal tissue after nasal application. ;Secondary Objective: Not applicable;Primary end point(s): To determine the bioavailability of MP29-02 in comparison with commercially available fluticasone propionate in human nasal mucosa. ;Timepoint(s) of evaluation of this end point: Approximately 1 hour after administration (during surgery). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed