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

NCT02883439 | Withdrawn

• 1 other identifier: 2015-002865-40
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability Study

Keywords

MP29-02

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Investigational product

EXPERIMENTAL

MP29-02 137

Drug: MP29-02

Non-investigational product

ACTIVE COMPARATOR

fluticasone propionate

Drug: Fluticasone propionate

Interventions

MP29-02 DRUG

local nasal application

Also known as: Dymista

Investigational product

Fluticasone propionate DRUG

local nasal application

Also known as: FP

Non-investigational product

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• MEDA Pharma GmbH & Co. KG: collaborator
• University of Wuerzburg: collaborator

Study Sites (1)

University Hospital Ghent, departement otorhinolaryngology

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

MP29-02; Fluticasone

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Claus Bachert

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: August 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)