Clinical Trials Register

Summary
EudraCT Number:	2010-023981-27
Sponsor's Protocol Code Number:	Acti-SCIPE-001
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-01-25
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

Germany - BfArM

A.2

EudraCT number

2010-023981-27

A.3

Full title of the trial

An Open-Label Randomized Pilot Trial to Evaluate Tolerability, Safety and Applicability of AKITA Inhaled Budesonide Suspension in Children aged 3-11 years with Mild to Moderate Asthma

A.3.2

Name or abbreviated title of the trial where available

SCIPE-001 – Safe Corticosteroid Inhalation in Pediatrics

A.4.1

Sponsor's protocol code number

Acti-SCIPE-001

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Activaero GmbH
B.1.3.4	Country	Germany
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Yes
D.2.1.1.1	Trade name	1) BudenoBronch mit der Stärke 1mg/2ml mit der Verwendung des AKITA Jet nebulizer
D.2.1.1.2	Name of the Marketing Authorisation holder	InfectoPharm Arzneimittel
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Nebuliser suspension
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Inhalation 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.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1mg/2ml
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Yes
D.3.11.13.1	Other medicinal product type	Glucocorticosteroid
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	BudenoBronch mit der Stärke 0,5g/2ml mit der Verwendung des PARI LC nebulizer
D.2.1.1.2	Name of the Marketing Authorisation holder	InfectoPharm Arzneimittel
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Nebuliser suspension
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Inhalation 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.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0,5mg/2ml
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Yes
D.3.11.13.1	Other medicinal product type	Glucocorticosteroid

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

Allergic or non-allergic mild to moderate asthma in children aged three to eleven years. Affected children need to suffer from mild to moderate asthma according to ATS definition at least for 6 months and need to be treated for at least for three months with inhaled corticosteroids before date of screening.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10003561
E.1.2	Term	Asthma, unspecified

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Objectives are to evaluate the airway tolerability, safety and applicability of nebulized Budesonide delivered with AKITA in children aged 3-11 years with asthma in comparison to delivery with conventional jet nebulizer.
1) To evaluate the airway tolerability of nebulized Budesonide
2) To monitor the safety of nebulized Budesonide as described by the safety variables. It is the general idea that, given the deposition efficacy and consistency of Akita, along with adherence monitoring, asthma control can be achieved in these children with a substantially lower nominal dose, shorter treatment times, and negligible oropharyngeal side effects.
3) Efficacy: To conduct exploratory measures of FEV1, asthma control and exhaled NO for descriptive purposes.
4) To observe the handling and applicability of AKITA JET Technology, to monitor differences in the application, problems and mistakes during application of AKITA Jet nebulizer.

E.2.2

Secondary objectives of the trial

1)From which age on a controlled positive airway pressure application/airflow control of inhaled budesonide is being tolerated?
2)Do children ≤ 4 years tolerate and correctly perform inhalation via mouthpiece?
3)Can/will they do this consistently at home?
4)What features of a controlled inhalation system are needed to facilitate its usage for inhalation in children?
5)Which volumes of inhalation and which breathing flow rates will be tolerated?
6)What minimal therapy time can be achieved?
7)To what extent do device training / feedback influence the outcome of the inhalation?
8)How high is treatment adherence?
9)To what extent will adherence feedback affect the outcome?
10)Is 125 µg Budesonide BID (with 50-70µg deposited per day) sufficient to control asthma symptoms?
11)What changes in
a)in FEV1 during treatment with either AKITA JET or conventional jet nebulizer
b)asthma symptom score
c)exhaled NO as a marker for inflammatory processes
can be observed/achieved?

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Written informed consent performed by parents or legal representatives of the child prior to the performance of any study-related procedures. Verbal assent of the child if in the Investigator’s opinion the child is capable of giving the assent.
2) Age ≥ 3 and ≤ 11 year of age
3) Diagnosis of mild-to-moderate asthma (ATS definition, either allergic or non-allergic) for ≥ 6 months and currently stable Asthma treated for at least 3 months with inhaled (ICS) corticosteroids (MDI/DPI). Current ICS treatment will be suspended during the treatment phase of the trial. Treatment with additional leukotriene antagonists (e.g. Montelukast) is allowed and remains unchanged throughout the study.
4) FEV1 ≥ 50% predicted at the Screening or Baseline Visit (children aged 6 years or older and able to perform spirometry)
5) Documented increase of at least 12% in absolute FEV1 within 15-30 minutes after the use of inhaled Salbutamol at the Screening Visit or within 6 months prior to Screening (children aged 6 years or older and able to perform spirometry).
6) A negative urine pregnancy test must be available for any girl of childbearing potential at screening and, in addition, a negative urine pregnancy test must be present at randomization (prior to randomization to one of the treatment groups!)

E.4

Principal exclusion criteria

1) History of allergy or adverse experience with Budesonide
2) Upper respiratory tract infection within 4 weeks of Screening
3) Emergency room visit for treatment of asthma exacerbation within 4 weeks of Screening
4) Hospitalization for asthma within 3 months of Screening
5) Use of inhaled LABA, theophylline, anti-IgE, or oral corticosteroids within 3 months of Screening.
6) Treatment with other investigational asthma treatment within 30 days prior to Screening.
7) Evidence of chronic lung diseases other than asthma, including but not limited to: cystic fibrosis, allergic bronchopulmonary aspergillosis (ABPA), chronic bronchitis and emphysema
8) History of medication noncompliance
9) History of significant medical illness or condition that in the Investigator’s opinion places the subject at undue risk by participating in the study
10) Past episode of anaphylaxis with severe respiratory symptoms
11) Taking oral or i.v. corticosteriods for any disease indication

E.5 End points

E.5.1

Primary end point(s)

The study will be conducted as an observational pilot study without determination of sample size. This is done due to the fact that there does not exist any data about efficacy of AKITA Jet in children for the treatment of pediatric asthma.
The primary objective of the study is to demonstrate the applicability of AKITA Jet technology with nebulized corticosteroid inhalation for the treatment of asthma in children.
The efficacy comparison of test treatment vs. comparator treatment will be performed descriptively only.

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

Yes

E.6.13.1

Other scope of the trial description

Applicability of Inhaler

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Budenobronch 0,5mg/2ml; 1,0 mg/2ml inhaled with Pari LC nebulizer

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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

Information not present in EudraCT

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

End of trial is the last study visit of the last subject undergoing the trial.

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

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.1.1.1

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)

Yes

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Children aged 3-11 years with Mild to Moderate Asthma

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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

2011-03-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-03-03

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-02-10

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