Open label two treatment half-side comparative study to analyse difference in nasal bioavailability between MP29-02 and fluticasone propionate. - BIODYMF

Ghent University Hospital0 个研究点目标入组 99,999 人开始时间: 2015年11月6日最近更新: 2021年8月10日

适应症

试验速览

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•-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
•-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

发起方