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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02883439
Recruitment Status : Withdrawn (no available patients)
First Posted : August 30, 2016
Last Update Posted : July 13, 2021
Sponsor:
Collaborators:
MEDA Pharma GmbH & Co. KG
University of Wuerzburg
Information provided by (Responsible Party):
University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE August 25, 2016
First Posted Date  ICMJE August 30, 2016
Last Update Posted Date July 13, 2021
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Analyse Difference in Bioavailability Between MP29-02 and Fluticasone Propionate
Official Title  ICMJE Open Label Two -Treatment Half Side Comparative Study to Analyse Difference in Bioavailability Between MP29-02 and Fluticasoen Propionate
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Bioavailability Study
Intervention  ICMJE
  • Drug: MP29-02
    local nasal application
    Other Name: Dymista
  • Drug: Fluticasone propionate
    local nasal application
    Other Name: FP
Study Arms  ICMJE
  • Experimental: Investigational product
    MP29-02 137
    Intervention: Drug: MP29-02
  • Active Comparator: Non-investigational product
    fluticasone propionate
    Intervention: Drug: Fluticasone propionate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 7, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2016)
24
Actual Study Completion Date  ICMJE March 2020
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02883439
Other Study ID Numbers  ICMJE 2015-002865-40
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE
  • MEDA Pharma GmbH & Co. KG
  • University of Wuerzburg
Investigators  ICMJE
Principal Investigator: Claus Bachert Upper Airways Research Laboratory, Department of Oto-Rhino-Laryngology, Ghent University Hospital, Ghent, Belgium.
PRS Account University Hospital, Ghent
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP