Clinical Trials Register

Summary
EudraCT Number:	2011-001368-23
Sponsor's Protocol Code Number:	MP4000
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2011-03-30
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2011-001368-23

A.3

Full title of the trial

Active-Controlled Trial of the Safety and Tolerability of MP29-02 in Subjects with Chronic Allergic or Nonallergic Rhinitis

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study assessing safety and tolerability of a nasal spray combination of azelastine and fluticasone in patients with chronic rhinitis

A.4.1

Sponsor's protocol code number

MP4000

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/82/2011

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	MedPointe Pharmaceuticals
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	MedPointe Pharmaceuticals
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	MEDA Pharma GmbH & Co. KG
B.5.2	Functional name of contact point	Department Clinical Development
B.5.3	Address:
B.5.3.1	Street Address	Benzstr. 1
B.5.3.2	Town/ city	Bad Homburg
B.5.3.3	Post code	61352
B.5.3.4	Country	Germany
B.5.4	Telephone number	004961728881265
B.5.5	Fax number	004961728882883
B.5.6	E-mail	joachim.maus@medapharma.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Fixed combination AZE-FLU nasal spray
D.3.2	Product code	MP29-02
D.3.4	Pharmaceutical form	Nasal spray, suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Nasal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	azelastine hydrochloride
D.3.9.1	CAS number	79307-93-0
D.3.9.3	Other descriptive name	AZE
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	137
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fluticasone propionate
D.3.9.1	CAS number	80474-14-2
D.3.9.3	Other descriptive name	FLU
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Fluticasone Propionate Nasal Spray
D.2.1.1.2	Name of the Marketing Authorisation holder	Roxane Laboratories Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Fluticasone propionate nasal spray
D.3.4	Pharmaceutical form	Nasal spray, suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Nasal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fluticasone propionate
D.3.9.1	CAS number	80474-14-2
D.3.9.3	Other descriptive name	FLU
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

treatment of chronic allergic or non-allergic rhinitis

E.1.1.1

Medical condition in easily understood language

treatment of chronic rhinitis

E.1.1.2

Therapeutic area

Diseases [C] - Ear, nose and throat diseases [C09]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	13.1
E.1.2	Level	LLT
E.1.2	Classification code	10034382
E.1.2	Term	Perennial allergic rhinitis
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	13.1
E.1.2	Level	LLT
E.1.2	Classification code	10034383
E.1.2	Term	Perennial rhinitis
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

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

E.2.2

Secondary objectives of the trial

not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Patients with established history (≥ 1 year) of rhinitis due to perennial allergies or non-allergic rhinitis (VMR)
• General good health and lack of any disease or concomitant treatment that could have interfered with the interpretation of the study results

E.4

Principal exclusion criteria

• Presence on nasal examination of any nasal ulceration (grade 3) or nasal septal perforation (grade 4) on screening visit or randomisation visit
• Nasal surgery or sinus surgery within the previous year
• Chronic sinusitis with more than 3 episodes per year
• Patients currently or during the previous 6-months on sublingual immunotherapy
• Patients with a fasting morning plasma cortisol level less than or equal to 5 µg/dL (or 150 nmol/L) for patients participating in the HPA axis sub-study
• Patients receiving immunotherapy injections and not on stable maintenance regimen for at least 30 days before the first study visit
• Use of systemic corticosteroid, omalizumab or inhaled corticosteroids / inhaled corticosteroid in combination 30 days prior to screening

E.5 End points

E.5.1

Primary end point(s)

• Frequency of patient-reported adverse events
• Evaluation of the cumulative effect of AZE-FLU by nasal examination
• Eye examination by an ophthalmologist

E.5.1.1

Timepoint(s) of evaluation of this end point

• Adverse events upon occurrence
• Cumulative effect of AZE-FLU by nasal examination: screening visit, randomisation visit, and visits on days 30, 90, 180, 270, and 365, if applicable
• Eye examination by an ophthalmologist: screening visit and visits on days 180 and 365, if applicable

E.5.2

Secondary end point(s)

• Adherence to therapy
• Efficacy as assessed by Total Nasal Symptom Score (TNSS)
• Fasting plasma cortisol levels (at selected study sites)

E.5.2.1

Timepoint(s) of evaluation of this end point

• Adherence to therapy: each study visit
• Efficacy as assessed by Total Nasal Symptom Score (TNSS):
Nasal symptom scores for rhinorrhea, sneezing, itchy nose, and nasal congestion (the sum of
which comprised the TNSS) were recorded twice daily (AM and PM) during the screening period. After randomization, scores were recorded once daily, in the evening (PM), as an evaluation of symptom severity over the previous 12 hours (12-hour reflective TNSS). This score was recorded once daily prior to the PM dose for MP29-02 subjects and once daily approximately 12 hours after the AM dose for the fluticasone propionate subjects for each day of the study.
• Fasting plasma cortisol levels (at selected study sites): screening visit and visits on days 180 and 365, if applicable

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

India

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

the last visit of the last subject:
2009-06-17

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

569

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

600

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

not applicable

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	no network involved
G.4.3.4	Network Country	India

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	India

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