Clinical Trial Results:
Open label two treatment half-side comparative study to analyse difference in nasal bioavailability between MP29-02 and fluticasone propionate.
Summary
|
|
EudraCT number |
2015-002865-40 |
Trial protocol |
BE |
Global end of trial date |
25 Feb 2019
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
25 Jul 2021
|
First version publication date |
25 Jul 2021
|
Other versions |
|
Summary report(s) |
Cancelled Before Active Statement |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
BIODYMF
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Ghent University Hospital
|
||
Sponsor organisation address |
Corneel Heymanslaan 10, Ghent, Belgium, 9000
|
||
Public contact |
Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
|
||
Scientific contact |
Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
25 Feb 2019
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
25 Feb 2019
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
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.
|
||
Protection of trial subjects |
Ethics review and approval, informed consent, supportive care and routine monitoring.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Oct 2015
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Belgium: 99999
|
||
Worldwide total number of subjects |
99999
|
||
EEA total number of subjects |
99999
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
99999
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
||||||||||
Recruitment
|
||||||||||
Recruitment details |
99999 is "Not applicable" value or 0 participants. | |||||||||
Pre-assignment
|
||||||||||
Screening details |
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 | |||||||||
Period 1
|
||||||||||
Period 1 title |
Overall Trial (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Not blinded | |||||||||
Arms
|
||||||||||
Are arms mutually exclusive |
No
|
|||||||||
Arm title
|
Flixonase aqua | |||||||||
Arm description |
1 dose each in a different nostril administered via single dose nasal spray. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Fluticasone propionate (flixonase aqua)
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Nasal spray, suspension
|
|||||||||
Routes of administration |
Nasal use
|
|||||||||
Dosage and administration details |
Each spray delivers 50 mcg of fluticasone propionate.
|
|||||||||
Arm title
|
MP29-02 | |||||||||
Arm description |
1 dose each in a different nostril administered via single dose nasal spray. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
MP29-02
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
Dymista
|
|||||||||
Pharmaceutical forms |
Nasal spray
|
|||||||||
Routes of administration |
Local use , Nasal use
|
|||||||||
Dosage and administration details |
Total dose: 0,14 g gram(s). Nasal use.
|
|||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Flixonase aqua
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
1 dose each in a different nostril administered via single dose nasal spray. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
MP29-02
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
1 dose each in a different nostril administered via single dose nasal spray. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Flixonase aqua
|
||
Reporting group description |
1 dose each in a different nostril administered via single dose nasal spray. | ||
Reporting group title |
MP29-02
|
||
Reporting group description |
1 dose each in a different nostril administered via single dose nasal spray. |
|
|||||||||||||
End point title |
To determine the bioavailability of MP29-02 in comparison with commercially available fluticasone propionate in human nasal mucosa. [1] | ||||||||||||
End point description |
99999 is "not applicable" value or 0 participants.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Approximately 1 hour after administration (during surgery).
|
||||||||||||
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis available. |
|||||||||||||
|
|||||||||||||
Notes [2] - No patients enrolled in the trial. [3] - No patients enrolled in the trial. |
|||||||||||||
No statistical analyses for this end point |
|
|||
Adverse events information [1]
|
|||
Timeframe for reporting adverse events |
Overall study
|
||
Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
|
|||
Dictionary name |
MedDRA | ||
Dictionary version |
24
|
||
Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events were recorded for the participating patients. |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
08 Nov 2016 |
Amendment to information in the CT application form, amendment to the protocol, changes in conduct or management of the trial, :
Some issues were clarified in the protocol, as well as the description of the IMP, previously indicated as flixonase aqua, was changed to a more broad description (without using 1 specific brand) as the use of the active substance fluticasone propionate. |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
No patients have been enrolled. The trial was never initiated. |