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

Study Overview
=================
Brief 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).

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

Conditions
-----------------
Bioavailability Study

Intervention / Treatment
-----------------
* Drug: MP29-02
* Drug: Fluticasone propionate


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational product<br>MP29-02 137 | Drug: MP29-02<br>* local nasal application<br>* Other names: Dymista;|
| Active Comparator: Non-investigational product<br>fluticasone propionate | Drug: Fluticasone propionate<br>* local nasal application<br>* Other names: FP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioavailability of MP29-02 in human nasal mucosa compared to commercially available fluticasone propionate | bioavailability of both medicines will be tested in nasal mucosa and nasal secretion 1 after application | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MP29-02