Clinical Trials Register

Summary
EudraCT Number:	2018-001324-19
Sponsor's Protocol Code Number:	BDS_18_01
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-06-14
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
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2018-001324-19

A.3

Full title of the trial

Demonstration of therapeutic equivalence/non-inferiority as well as early onset of action of the novel water-soluble budesonide nasal spray (Budesolv) compared with marketed Rhinocort® aqua 64 in patients suffering from grass pollen induced allergic rhinitis/rhinoconjunctivitis with or without controlled asthma.

Nachweis der therapeutischen Äquivalenz/non-inferiority sowie des früheren Wirkungseintritts eines neuartigen Nasensprays mit wässrig gelöstem Budesonid (Budesolv 10) im Vergleich mit dem zugelassenen Arzneimittel Rhinocort ® aqua 64 an Gräserpollenallergikern mit oder ohne kontrolliertem Asthma.

A.3.1

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

Demonstration of equivalent effectiveness of a novel anti-allergic nasal spray and a marketed nasal product as well as demonstration of fast symptom reduction in allergic patients.

A.4.1

Sponsor's protocol code number

BDS_18_01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Marinomed Biotech AG
B.1.3.4	Country	Austria
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	Wiener Wirtschaftsagentur
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Marinomed Biotech AG
B.5.2	Functional name of contact point	Project manager
B.5.3	Address:
B.5.3.1	Street Address	Veterinärplatz 1
B.5.3.2	Town/ city	Vienna
B.5.3.3	Post code	1210
B.5.3.4	Country	Austria
B.5.4	Telephone number	+431250774460
B.5.6	E-mail	andreas.goessl@marinomed.com

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	Budesolv 10 micrograms, nasal spray
D.3.4	Pharmaceutical form	Nasal spray, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intranasal use (Noncurrent) Nasal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BUDESONIDE
D.3.9.1	CAS number	51333-22-3
D.3.9.2	Current sponsor code	n.a.
D.3.9.4	EV Substance Code	SUB05955MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
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	Rhinocort Aqua 64 Mikrogramm, Nasal-Pumpspray
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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.3.4	Pharmaceutical form	Nasal spray, suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intranasal use (Noncurrent) Nasal use
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Nasal spray, solution
D.8.4	Route of administration of the placebo	Nasal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Allergic Rhinitis/ Rhinoconjunctivitis

E.1.1.1

Medical condition in easily understood language

Hayfever/Allergy

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10039085
E.1.2	Term	Rhinitis allergic
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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10019170
E.1.2	Term	Hay fever
E.1.2	System Organ Class	10021428 - Immune system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10048908
E.1.2	Term	Seasonal allergy
E.1.2	System Organ Class	10021428 - Immune system 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

The primary objective of the trial is to demonstrate therapeutic equivalence/non-inferiority between Budesolv 10 and Rhinocort® aqua 64, a marketed comparator containing the same compound (budesonide), in patients suffering from grass pollen induced allergic rhinitis/rhinoconjunctivitis with or without controlled asthma on day 8 of treatment.

E.2.2

Secondary objectives of the trial

Secondary objective of the trial is the early onset of action of Budesolv 10 compared to Rhinocort® aqua 64, determined on day one of treatment.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

I1. Written informed consent obtained before any trial related procedures are performed
I2. Healthy male or female subjects aged 18 years or older
I3. Female subjects of child-bearing potential must have a negative pregnancy test and be willing to practice appropriate contraceptive
methods until the end of treatment visit
I4. A documented clinically relevant allergic history of moderate to severe SAR to grass pollen for the previous two years
I5. Subjects exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 within the first 2 hours in the Vienna Challenge Chamber, which is defined as total nasal symptom score (TNSS) of at least 6 (out of 12) using standard VCC grass pollen allergen mixture. Nasal symptom score is the sum of “nasal congestion”, “rhinorrhea”, “itchy nose” and “sneezing”, each of which have been scored on a categorical scale from 0 to 3.
I6. Positive Skin Prick Test (SPT) response (wheal diameter at least 3 mm larger than diluent control) to grass pollen SPT solutions (standard Allergopharma) at screening or within the last 6 months prior to study start.
I7. Positive serum specific IgE against recombinant major allergen components of the used grass pollen (specific CAP IgE ≥0.70 kU/L) at screening or within the last 6 months prior to study start.
I8. Patients with a body weight of ≥ 50kg and a body mass index within the range of 19-30kg/m2.
I9. Non-smoking subjects (smoked <10 packs years in their lifetime and had not smoked in the last 6 months)
I10. Asthma patients only if the asthma condition is mild or intermittent, and if those are not treated with steroids
I11. Subject has a forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value (ECCS) at the screening.
I12. Subject is capable of understanding the study procedures and potential risks associated with the study, and voluntarily agrees to participate by giving written informed consent.
I13. Subject is able to adhere to dose and visit schedules.
I14. Subject is able to read, understand and complete questionnaires and diaries.

E.4

Principal exclusion criteria

E1 Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method (pregnancy to be controlled by a pregnancy dipstick test).
E2 A clinical history of uncontrolled asthma within 3 months prior to screening.
E3 Subjects with asthma requiring treatment with inhaled corticosteroids on a regular basis judged by the investigator.
E4 Previous successful immunotherapy to grass pollen, a grass pollen allergen or a cross-reacting allergen within the past 3 years.
E5 Ongoing treatment with any allergen-specific immunotherapy product.
E6 Subjects with a current oral candidiasis infection or treatment for oral candidiasis during the last 30 days before starting the study.
E7 Subjects with history of tuberculosis.
E8 Subjects with any fungal/viral/bacterial respiratory or systemic infections during the last 30 days.
E9 Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization.
E10 Clinically relevant nasal polyps, medical history of paranasal sinus surgery and/or medical history of surgery of nasal turbinates judged by the investigator.
E11 Subjects with glaucoma or a family history of glaucoma.
E12 Subjects using any ophthalmic steroids during the last 30 days.
E13 Subjects treated with nasal, inhaled or systemic steroids during the last 30 days.
E14 History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise induced, food allergy, drugs or an idiopathic reaction).
E15 Any clinically relevant chronic disease judged by the investigator.
E16 Systemic disease affecting the immune system judged by the investigator.
E17 Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening.
E18 History of allergy, hypersensitivity or intolerance to any ingredients of the IMP.
E19 History of alcohol or drug abuse.
E20 Being immediate family of the investigator or trial staff, defined as the investigator's/staff’s spouse, parent, child, grandparent or grandchild.
E21 Subjects with previous SAR that has proven unresponsive to steroid therapy.
E22 Subjects treated with leukotriene antagonists (1 month before study start), long-lasting anti-histamines, like cetirizine, fexofenandine, loratadine, desloratadine, hydroxyzine (5 to 10 days before study start), mast cell stablizier (2 weeks before study start) or nasal decongestant (3 days before study start).
E23 Subjects with an acute or chronic sinusitis judged by the investigator.
E24 Subjects with hypersensitivity to corticosteroids judged by the investigator.
E25 Subjects with ocular herpes simplex infections.
E26 Subjects with cataracts and with cataract history.

E.5 End points

E.5.1

Primary end point(s)

Total nasal symptom score

E.5.1.1

Timepoint(s) of evaluation of this end point

day 8 / 2h-6h

E.5.2

Secondary end point(s)

Total nasal symptom score

E.5.2.1

Timepoint(s) of evaluation of this end point

day 1 / 2h-6h

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

Yes

E.6.13.1

Other scope of the trial description

therapeutic equivalence according to CPMP/EWP/239/95

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

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

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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.4.1

In the member state

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)

none

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-08-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-07-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-04-05

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