Study to Analyse Difference in Bioavailability Between MP29-02 and Fluticasone Propionate

• Status: Withdrawn
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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. This may provide a rational basis for the use of 1 puff per nostril dosage regimen of the drugs. Clinical experience has demonstrated the efficacy of the twice-daily treatment; however, so far, no data are available on the local tissue concentrations of MP29-02 after topical application.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Collaborators: MEDA Pharma GmbH & Co. KG; University of Wuerzburg
• Treatments: Fluticasone; Xhance

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

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