Clinical Trial Results:
Active-Controlled Trial of the Safety and Tolerability of MP29-02 in Subjects with Chronic Allergic or Nonallergic Rhinitis
Summary
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EudraCT number |
2011-001368-23 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
17 Jun 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jul 2016
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First version publication date |
29 Jul 2016
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MP4000
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Additional study identifiers
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ISRCTN number |
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US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Meda Pharmaceuticals
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Sponsor organisation address |
265 Davidson Avenue, Suite 300, Somerset, United States, 08873-4120
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Public contact |
Group leader study managers, MEDA Pharma GmbH Co. KG, +49 617288801, 42b@medapharma.de
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Scientific contact |
Head Corporate Clinical Affairs, MEDA Pharma GmbH Co. KG, +49 617288801, 42b@medapharma.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000990-PIP02-10 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Oct 2010
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
17 Jun 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Jun 2009
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the safety and tolerability of azelastine hydrochloride and fluticasone propionate combination nasal spray in chronic use daily over a 1-year period.
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Protection of trial subjects |
No specific additional measures to minimise pain and distress were required. The patients could withdraw from Treatment at any time and for any reason.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
16 Jan 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
India: 612
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Worldwide total number of subjects |
612
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
1
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Adolescents (12-17 years) |
36
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Adults (18-64 years) |
569
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From 65 to 84 years |
6
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85 years and over |
0
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Recruitment
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Recruitment details |
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Pre-assignment
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Screening details |
Subjects 12 to 80 years of age with a history of chronic rhinitis symptoms due to perennial allergic rhinitis, perennial nonallergic rhinitis, or VMR who might benefit from continuous therapy with MP29-02 were considered for entry into the study. Subjects who met the study entry criteria were enrolled following an initial 7-day screening period. | ||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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MP29-02 nasal spray | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
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Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Azelastine hydrochloride and fluticasone propionate
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Investigational medicinal product code |
MP29-02
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Intranasal use , Topical use
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Dosage and administration details |
Mode of Administration: Topical/intranasal spray
Dose: 137 mcg azelastine hydrochloride and 50 mcg fluticasone propionate/ spray
Regimen: 1 spray per nostril bid (morning [AM] and evening [PM])
Duration of Treatment: 12 months
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Arm title
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Fluticasone nasal spray | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
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Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Fluticasone propionate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Intranasal use , Topical use
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Dosage and administration details |
Mode of Administration: Topical/intranasal spray
Dose: 50 mcg fluticasone propionate/ spray
Regimen: 2 sprays per nostril qd (AM)
Duration of Treatment: 12 months
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Baseline characteristics reporting groups
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Reporting group title |
MP29-02 nasal spray
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Reporting group description |
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Reporting group title |
Fluticasone nasal spray
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
MP29-02 nasal spray
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Reporting group description |
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Reporting group title |
Fluticasone nasal spray
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Reporting group description |
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Subject analysis set title |
Safety population for MP29-02
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Safety population for MP29-02.
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Subject analysis set title |
Safety population for Fluticasone Propionate
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Safety population for Fluticasone Propionate.
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End point title |
Number of AEs Reported [1] | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Safety and tolerability assessments were made at Months 1, 3, 6, 9, and 12. Phone contact was made at Months 2, 4, 5, 7, 8, 10, and 11 during the 12-month evaluation period.
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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 for the safety end point - number of AEs reported - was performed. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Safety and tolerability assessments were made at Months 1, 3, 6, 9, and 12. Phone contact was made at Months 2, 4, 5, 7, 8, 10, and 11 during the 12-month evaluation period.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11.1
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Reporting groups
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Reporting group title |
Fluticasone nasal spray
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Reporting group description |
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Reporting group title |
MP29-02 nasal spray
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Reporting group description |
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Frequency threshold for reporting non-serious adverse events: 2.7% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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29 Nov 2007 |
Protocol amended to include change in methodology of the study (increase of patients in one treatment arm of the sub-study) |
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21 Jan 2008 |
Protocol amended to include administrative modifications related to the implementation of the first protocol amendment |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |