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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Bioavailability Study
• Intervention / Treatment: Drug: MP29-02; Drug: Fluticasone propionate

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).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent, departement otorhinolaryngology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational product; MP29-02 137	Drug: MP29-02; local nasal application; Other Names: Dymista
Active Comparator: Non-investigational product; fluticasone propionate	Drug: Fluticasone propionate; local nasal application; 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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: MEDA Pharma GmbH & Co. KG; University of Wuerzburg
• Investigators: Principal Investigator: Claus Bachert, Upper Airways Research Laboratory, Department of Oto-Rhino-Laryngology, Ghent University Hospital, Ghent, Belgium.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: MP29-02
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance
• Other Study ID Numbers: 2015-002865-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No