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

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ClinicalTrials.gov Identifier: NCT02883439
Recruitment Status : Unknown
Verified August 2016 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Collaborators:
MEDA Pharma GmbH & Co. KG
University of Wuerzburg
Information provided by (Responsible Party):
University Hospital, Ghent

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.

Condition or disease Intervention/treatment Phase
Bioavailability Study Drug: MP29-02 Drug: Fluticasone propionate Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Open Label Two -Treatment Half Side Comparative Study to Analyse Difference in Bioavailability Between MP29-02 and Fluticasoen Propionate
Study Start Date : August 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2
MP29-02 137 microgram, one time only 1 spray
Drug: MP29-02
local nasal application
Other Name: Dymista

Active Comparator: 1
fluticasone propionate 50 microgram, one time only 1 spray
Drug: Fluticasone propionate
local nasal application




Primary Outcome Measures :
  1. bioavailability of MP29-02 in human nasal mucosa compared to commercially available fluticasone propionate [ Time Frame: 1 hour ]
    bioavailability of both medicines will be tested in nasal mucosa and nasal secretion 1 after application



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883439


Contacts
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Contact: Claus Bachert, MD, PhD claus.bachert@ugent.be

Locations
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Belgium
University Hospital Ghent, departement otorhinolaryngology Recruiting
Ghent, Belgium, 9000
Contact: Lara Derycke, phD    003293321246      
Sponsors and Collaborators
University Hospital, Ghent
MEDA Pharma GmbH & Co. KG
University of Wuerzburg
Investigators
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Principal Investigator: Claus Bachert Upper Airways Research Laboratory, Department of Oto-Rhino-Laryngology, Ghent University Hospital, Ghent, Belgium.
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02883439    
Other Study ID Numbers: 2015-002865-40
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Ghent:
MP29-02
Additional relevant MeSH terms:
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Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents