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

NCT ID: NCT02883439

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2020-03-31

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).

Conditions

Bioavailability Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Investigational product

MP29-02 137

Group Type: EXPERIMENTAL

MP29-02

Intervention Type: DRUG

local nasal application

Non-investigational product

fluticasone propionate

Group Type: ACTIVE_COMPARATOR

Fluticasone propionate

Intervention Type: DRUG

local nasal application

Interventions

MP29-02

local nasal application

Intervention Type: DRUG

Fluticasone propionate

local nasal application

Intervention Type: DRUG

Other Intervention Names

Dymista; FP

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MEDA Pharma GmbH & Co. KG

INDUSTRY

Sponsor Role: collaborator

University of Wuerzburg

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claus Bachert

Role: PRINCIPAL_INVESTIGATOR

Upper Airways Research Laboratory, Department of Oto-Rhino-Laryngology, Ghent University Hospital, Ghent, Belgium.

Locations

University Hospital Ghent, departement otorhinolaryngology

Ghent, , Belgium

Countries

Belgium

Other Identifiers

2015-002865-40

Identifier Type: -

Identifier Source: org_study_id