NCT02883439

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

Open Label Two -Treatment Half Side Comparative Study to Analyse Difference in Bioavailability Between MP29-02 and Fluticasoen Propionate

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will be a single-centre, two-treatment half-side comparative open-label trial; all subjects will receive Dymista® or Flixonase Aqua in one nostril each. Nasal tissue samples will be obtained from 24 patients. Subjects will be selected based on the subjects plan to undergo septoplasty, septorhinoplasty, or functional endoscopic sinus surgery. Subjects with different diagnoses can be added in the study: non-allergic rhinitis, allergic rhinits, chronic sinusitis and nasal polyposis. The number of subjects is based on a previous experiment where the presence of fluticasone propionate was tested on human nasal mucosal surface and in human nasal tissue after nasal application (Bonsmann, 2001).

Conditions

• Bioavailability Study

Interventions

Type	Name	Description
DRUG	MP29-02	local nasal application
DRUG	Fluticasone propionate	local nasal application

Timeline

• Start date: 2016-08-01
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2016-08-30
• Last updated: 2021-07-13

Locations

1 site across 1 country: Belgium