Difference in nasal bioavailability between MP29-02 and fluticasone propionate.
- Conditions
- Subjects who need to undergo septoplasty, septorhinoplasty or functional endoscopic sinus surgery unrelated to this study.Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2015-002865-40-BE
- Lead Sponsor
- Ghent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 99999
-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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None