Clinical Trials Register

Summary
EudraCT Number:	2009-016757-18
Sponsor's Protocol Code Number:	CCD-0807-PR-0024
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2012-02-27
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2009-016757-18

A.3

Full title of the trial

A phase III, 12-week, multicentre, multinational, randomised, double-blind, double-dummy, 3 arm-parallel group study to test the efficacy of CHF 1535 50/6 microg (fixed combination of beclomethasone dipropionate plus formoterol fumarate) versus a free combination of beclomethasone dipropionate 50 microg plus formoterol fumarate 6 microg and versus a monotherapy of beclomethasone dipropionate 50 microg in partly controlled asthmatic children

Studio di fase III, di 12 settimane, multicentrico, multinazionale, randomizzato, doppio cieco, controllato verso placebo, 3 bracci a gruppi paralleli per provare l'efficacia di CHF 1535 50/6 microg (combinazione fissa di beclometasone dipropionato piu' formoterolo fumarato) verso una combinazione libera di beclometasone dipropionato 50 microg piu' formoterolo fumarato 6 microg e di una monoterapia di beclometasone dipropionato 50 microg in bambini con asma parzialmente controllata

A.3.1

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

Multinational Clinical Trial of 12 weeks of duration to test the efficacy of a new drug called CHF 1535 50/6 (fixed combination of a corticoteroid and a long-acting Beta 2 agonist) compared to a free combination of the same substances, and to the corticosteroid only in asthmatic children

Studio clinico multinazionale di 12 settimane per testare l'efficacia di un nuovo farmaco chiamato CHF 1535 50/6 (combinazione fissa di un corticoteroide e di un Beta 2 agonista con lunga durata d'azione ) rispetto ad una combinazione libera delle sostanze stesse, e alla monosomministrazione del corticosteroide in bambini asmatici

A.4.1

Sponsor's protocol code number

CCD-0807-PR-0024

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/088/2010

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	CHIESI
B.1.3.4	Country	Italy
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	Chiesi Farmaceutici SpA
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Chiesi Farmaceutici SpA
B.5.2	Functional name of contact point	Corporate Clinical Development Dep.
B.5.3	Address:
B.5.3.1	Street Address	avenue Dubonnet 11
B.5.3.2	Town/ city	Courbevoie
B.5.3.3	Post code	92407
B.5.3.4	Country	France
B.5.4	Telephone number	+33 (0)1 47684 812
B.5.5	Fax number	+33 (0)1 47684 904
B.5.6	E-mail	f.zuccaro@chiesifrance.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	CHF 1535 50/6 microg pMDI
D.3.2	Product code	CHF 1535 50/6 microg pMDI
D.3.4	Pharmaceutical form	Pressurised inhalation, solution
D.3.4.1	Specific paediatric formulation	Yes
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	BECLOMETASONE DIPROPIONATE
D.3.9.1	CAS number	5534-09-8
D.3.9.2	Current sponsor code	BDP
D.3.9.3	Other descriptive name	BECLOMETASONE DIPROPIONATE
D.3.9.4	EV Substance Code	SUB00681MIG
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FORMOTEROL FUMARATE
D.3.9.1	CAS number	43229-80-7
D.3.9.2	Current sponsor code	FF
D.3.9.3	Other descriptive name	FORMOTEROL FUMARATE
D.3.9.4	EV Substance Code	SUB02257MIG
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	6
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	Ventolair
D.2.1.1.2	Name of the Marketing Authorisation holder	IVAX Pharma GmbH
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	Pressurised inhalation, solution
D.3.4.1	Specific paediatric formulation	No
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	BECLOMETASONE DIPROPIONATE
D.3.9.1	CAS number	5534-09-8
D.3.9.2	Current sponsor code	BDP
D.3.9.3	Other descriptive name	BECLOMETASONE DIPROPIONATE
D.3.9.4	EV Substance Code	SUB00681MIG
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: 3
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	ATIMOS*SOLxINAL 6MCG 120D
D.2.1.1.2	Name of the Marketing Authorisation holder	CHIESI FARMACEUTICI SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Pressurised inhalation, solution
D.3.4.1	Specific paediatric formulation	No
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	FORMOTEROL FUMARATE
D.3.9.1	CAS number	43229-80-7
D.3.9.2	Current sponsor code	FF
D.3.9.3	Other descriptive name	FORMOTEROL FUMARATE
D.3.9.4	EV Substance Code	SUB02257MIG
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	6
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	Pressurised inhalation, solution
D.8.4	Route of administration of the placebo	Inhalation use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Pressurised inhalation, solution
D.8.4	Route of administration of the placebo	Inhalation use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Asthma

Asma

E.1.1.1

Medical condition in easily understood language

Asthma

Asma

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	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10038738
E.1.2	Term	Respiratory, thoracic and mediastinal disorders
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 demonstrate that CHF 1535 50/6 μg pMDI (daily dose: BDP 200 μg/FF 24 μg) is superior to the corresponding monotherapy with beclomethasone dipropionate 50 μg pMDI (daily dose: BDP 200 μg) and non-inferior relative to the corresponding free combination of beclomethasone dipropionate 50 μg pMDI (daily dose: BDP 200 μg) plus formoterol fumarate 6 μg pMDI (daily dose: FF 24 μg) (all treatments administered via the AeroChamber Plus™ spacer device) in terms of pulmonary function (change from baseline in pre-dose morning FEV1 after a 12-week treatment period) in children patients with ''partly controlled'' persistent asthma

Dimostrare che CHF 1.535 50/6 mcg pMDI (dose giornaliera: BDP 200 mcg/FF 24 mcg) è superiore alla monosomministrazione di beclometasone dipropionato 50 mg pMDI (dose giornaliera: 200 mcg BDP) e non-inferiore rispetto alla corrispondente combinazione libera di beclometasone dipropionato mg pMDI 50 (dose giornaliera: 200 mcg BDP) e formoterolo fumarato pMDI 6 mg (dose giornaliera: FF 24 mg) (tutti i trattamenti verranno somministrati con l'apparecchio distanziatore AeroChamber Plus ™) in termini di miglioramento della funzione polmonare (diminuzione del FEV1pre-dose mattina rispetto al basale dopo un periodo di 12 settimane di trattamento) nei pazienti pediatrici affetti da asma persistente ''in parte controllata''

E.2.2

Secondary objectives of the trial

- To evaluate the effect of the treatments on additional lung function parameters and on clinical outcome measures; - To assess the safety and the tolerability of the administered treatments

- Valutare l'effetto dei trattamenti su parametri aggiuntivi della funzione polmonare e su misure di outcome clinici; - Valutare la sicurezza e la tollerabilità dei trattamenti somministrati

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written informed consent obtained from the parents/legal representatives (according to the local regulation) and written or verbal assent by the patient (when appropriate) prior to any study related procedures. 2. Prepuberal male and female outpatients, aged ≥ 5 and < 12 years in Tanner stages I and II according to Investigator's assessment. 3. Clinical diagnosis of asthma (GINA revised 2009) at least six months prior to screening visit. 4. Evidence of ''partly controlled'' asthma during the 2-week run-inperiod defined as following (GINA revised 2009), i.e. at least one of the following: - daytime symptoms more than twice/week, - any limitations of activities, - any nocturnal symptoms / awakening, - need for reliever/rescue treatment more than twice a week. 5. Treated with inhaled β2-agonists as required. 6. Symptomatic asthmatic patients treated with inhaled beclomethasone dipropionate (BDP) up to 400 μg or equivalent at a stable dose for at least 4 weeks prior to screening visit. Equivalence to: BDP non-extrafine ≤ 400 μg BDP extrafine ≤ 200 μg Budesonide ≤ 400 μg Ciclesonide ≤ 320 μg Flunisolide ≤ 1250 μg Fluticasone ≤ 500 μg Mometasone ≤ 400 μg Triamcinolone ≤1200 μg Patients under combination ICS-LABA or ICS-LTRA can enter into the study at the corresponding ICS dose, according to GINA guidelines (i.e. maximum 200 μg of non-extrafine BDP or equivalent). 7. A documented positive response to the reversibility test, defined as ΔFEV1 ≥ 12% over baseline, 15 minutes after 400 μg salbutamol pMDI via a Volumatic™ spacer device (ATS/ERS taskforce 2005) within 6 months prior to the screening must be provided. If not available, this test must be done at screening. 8. Forced Expiratory Volume during the first second (FEV1) ≥ 60% and ≤ 95% of predicted normal values at the screening visit and at the randomisation visit. 9. A cooperative attitude/ability and physical capacity to use a pMDI and a spacer device and perform lung functions.

1. Consenso informato scritto dai genitori/rappresentante legale (secondo il regolamento locale) e assenso scritto o verbale da parte del paziente (se del caso) ottenuto prima di qualsiasi procedura prevista dallo studio. 2. Pazienti ambulatoriali prepubere di sesso maschile e femminile, di età ≥ 5 e <12 anni di stadio I e II secondo la valutazione di Tanner. 3. Diagnosi clinica di asma (GINA rivisto 2009) almeno sei mesi prima della visita di screening. 4. Evidenza di diagnosi di asma ''parzialmente controllato'' durante le 2 settimane di run-in periodo definito come segue (GINA rivisto 2009), cioè almeno uno dei seguenti: - sintomi diurni più di due volte / settimana, - eventuali limitazioni delle attività, - qualsiasi sintomo notturno/risveglio, - necessità di trattamento di salvataggio più di due volte alla settimana. 5. Trattati con β2-agonisti per via inalatoria come richiesto. 6. Pazienti asmatici sintomatici trattati con beclometasone dipropionato per via inalatoria (BDP) fino a 400 mcg o equivalente ad una dose stabile per almeno 4 settimane prima della visita di screening. Equivalenza: BDP non extrafine ≤ 400 mcg BDP extrafine ≤ 200 mg Budesonide ≤ 400 mg ciclesonide ≤ 320 Flunisolide mg ≤ 1250 mg Fluticasone ≤ 500 mg Mometasone ≤ 400 mg Triamcinolone ≤ 1200 mg in pazienti combinazione ICS-LABA e ICS-LTRA può entrare nello studio alla dose ICS corrispondente, secondo le linee guida GINA (massimo cioè 200 mg di non extrafine BDP o equivalente). 7. Deve essere fornita una risposta documentata positiva al test di reversibilità, definita come ΔFEV1 ≥ 12% rispetto al basale, 15 minuti dopo 400 mcg di salbutamolo pMDI tramite un Volumatic ™ apparecchio distanziatore (ATS / ERS task force 2005) entro 6 mesi precedenti lo screening. Se non è disponibile, questo test deve essere fatto al momento dello screening. 8. Volume espiratorio forzato durante il primo secondo (FEV1) ≥ 60% e ≤ 95% dei valori normali alla visita di screening e alla visita di randomizzazione. 9. Un atteggiamento cooperativo/abilità e capacità fisica di usare un pMDI e un apparecchio distanziatore ed eseguire le funzioni polmonari.

E.4

Principal exclusion criteria

1. Patients with two or more admissions to hospital for asthma exacerbation in the past 12 months or any admission to intensive care ever. 2. Any concomitant disease requiring additional treatment with systemic glucocorticosteroids. 3. Regular use of anticholinergics. 4. Allergy to one component of medications used. 5. Intolerance or contra-indication to treatment with β2-agonists and/or inhaled corticosteroids. 6. Having received an investigational drug within 2 months before the current study. 7. Patients and/or parents unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments. 8. Occurrence of acute asthma exacerbations or lower respiratory tract infections in the 4 weeks preceding the screening visit or during the runin period. 9. History of cystic fibrosis, bronchiectasis, primary ciliary dyskinesia, bronchopulmonary dysplasia, or previous premature children with less than 36 weeks of gestational age. 10. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit). 11. Diagnosis of restrictive lung disease. 12. Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the investigator's opinion. 13. QTc interval (Fridericia's formula) higher than 450 msec (for boys)and 470 msec (for girls) at screening visit and randomisation visit. 14. Current smokers.

1. I pazienti con due o più ricoveri in ospedale per esacerbazione di asma negli ultimi 12 mesi o qualsiasi ammissione alle cure intensive. 2. Eventuali malattie concomitanti che richiedono un trattamento sistemico supplementare con glucocorticosteroidi. 3. Regolare uso di anticolinergici. 4. Allergia a una componente dei farmaci utilizzati. 5. L'intolleranza o controindicazione al trattamento con β2-agonisti e/o corticosteroidi per via inalatoria. 6. Aver ricevuto un farmaco sperimentale negli ultimi 2 mesi prima lo studio corrente. 7. I pazienti e/o i genitori incapaci di essere complianti o di comprendere la natura e lo scopo dello studio o i possibili benefici o effetti indesiderati dei trattamenti in studio. 8. Ricorrenza di esacerbazioni di asma acuto o di infezioni del tratto inferiore respiratorio nelle 4 settimane precedenti la visita di screening o durante il periodo di runin. 9. Storia di fibrosi cistica, bronchiectasie, discinesia ciliare primaria, displasia broncopolmonare o prematurità con meno di 36 settimane di età gestazionale. 10. Storia di episodio quasi fatale di asma (ad esempio asma insatbile, ospedalizzazione per esacerbazione asma in unità di terapia intensiva). 11. Diagnosi di malattia polmonare restrittiva. 12. Significativa anamnesi e/o trattamenti per patologia cardiaca, renale, neurologica, epatica, endocrina o qualsiasi anomalia di laboratorio indicativa di una condizione sottostante significativa, che possa interferire con la sicurezza del paziente, la compliance o le valutazioni, secondo il parere del ricercatore. 13. Iintervallo lungo del QTc (formula di Fridericia) superiore a 450 msec (per ragazzi) e 470 msec (per le ragazze) durante la visita di screening e la visita di randomizzazione. 14. Attuali fumatori.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline to end of treatment (Week 12, V5) in pre-dose morning FEV1 (L).

Cambiamento alla fine del trattamento (12 settimane, V5)nel pre-dosaggio mattutino di FEV1 rispetto al basale

E.5.1.1

Timepoint(s) of evaluation of this end point

V2 (week 0) and V5 (week 12)

V2 (settimana)e V5(settimana 12)

E.5.2

Secondary end point(s)

- change from baseline in pre-dose morning FEV1 and FVC at each clinic visit; - mean change from baseline in pre-dose morning FEV1 and FVC; - change from baseline in pre-dose morning and evening PEF (measured with electronic manual spirometer); - change from baseline in daily PEF variability; - change from baseline in daytime and night-time asthma symptom scores; - change from baseline in percentage of symptom-free days; - change from baseline in daytime and night-time use of rescue salbutamol (number of inhalations); - change from baseline in percentage of rescue salbutamol-free days; - change from baseline in percentage of asthma control days. - change from baseline in Standardised Paediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) score; - number of asthma exacerbations, number of patients with asthma exacerbations and asthma exacerbation rate; - FeNO parameter expressed as percentage of baseline (as explorative evaluation in a subgroup of 10% of patients in pre-selected centres). - Adverse events and adverse drug reactions. - Heart rate, systolic and diastolic blood pressure in sitting position, predose (V1 to V5) and 30 min post-dose at each visit (V2 to V5). - Standard haematology and blood chemistry at V2 and V5. - 12-lead ECG (including QTc interval corrected by Fridericia's formula), pre-dose at V1, pre-dose and 30 min post-dose at V2 and V5. - 12-hour overnight urinary free cortisol/creatinine ratio at V2 and V5.

- cambiamento ad ogni visita clinica del pre-dosaggio al mattino del FEV1 e FVC rispetto al basale, - variazione media rispetto al basale del pre-dosaggio al mattino di FEV1 e FVC; - variazione rispetto al basale del pre-dosaggio di PEF al mattino e alla sera (misurati con spirometro manuale elettronico); - cambiamento rispetto al basale della variabilità quotidiana del PEF, - cambiamento rispetto al basale nel punteggio dei sintomi asmatici diurni e notturni; - variazione percentuale rispetto al basale di giorni senza sintomi; - variazione rispetto al basale nell'uso diurno e notturno di salbutamolo al bisogno (numero di inalazioni); - variazione percentuale rispetto al basale di giorni liberi dall'uso di salbutamolo al bisogno - variazione percentuale rispetto al basale dei giorni di controllo dell'asma. - Variazione rispetto al basale del punteggio tramite il Qustionario standardizzato sulla Qualità della vita per pazienti pediatrici affetti da asma(PAQLQ (S)); - numero di esacerbazioni d'asma, numero di pazienti con esacerbazioni d'asma e tasso di esacerbazione dell'asma; - FeNO parametro espresso come percentuale del valore basale (valutazione esplorativa in un sottogruppo di pazienti pari al 10% in centri pre-selezionati). - Gli eventi avversi e reazioni avverse ai farmaci. - La frequenza cardiaca, pressione arteriosa sistolica e diastolica in posizione seduta, predose (V1 a V5) e a min 30 post-dose ad ogni visita (V2 a V5). - Standard analisi emato-chimiche del sangue al V2 e V5. - ECG a 12 derivazioni (compreso l'intervallo QT corretto con la formula Fridericia), pre-dose alla V1, pre-dose e 30 minuti dopo la somministrazione alla V2 e V5. - analisi delle urine delle 12 ore durante la notte libere da cortisolo/ creatinina a V2 e V5.

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary efficacy end points will be evaluated at study visits according to the schedule of assessment reported in the study protocol. PAQLQ, Routine haematology and blood chemistry and FeNO test will be evaluated at V2 (week =) and V5 (week12). 12-lead ECG will be evaluated at V1 (week -2), V2 (week 0) and V5 (week 12)

End point secondario di efficacia sarà valutato alle visite in studio in accordo al programma di valutazione riportato nel protocollo di studio. PAQLQ, ematologia e chimica del sangue di routine e test FeNO saranno valutate a V2 (settimana =) e V5 (week12). ECG a 12 derivazioni sarà valutato a V1 (settimana -2), V2 (settimana 0) e V5 (Settimana 12)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

double dummy

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Russian Federation

Ukraine

E.8.7

Trial has a data monitoring committee

Yes

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

Last Visit of the Last Subject

Ultima visita dell'ultimo paziente arruolato

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

Number of subjects for this age range:

700

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.1.1.5.1

Number of subjects for this age range:

700

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

The participants are under age and are not allowed to decide partricipation themselves. Parents must consent if the child verbally and bodily agree

SOGGETTI MINORI

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

180

F.4.2

For a multinational trial

F.4.2.1

In the EEA

800

F.4.2.2

In the whole clinical trial

1000

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)

After the participation in the trial the subjects will be treated according to the standard treatment care expected for their condition

In seguito alla partecipazione alla sperimentazione i soggetti saranno trattati per la loro condizione secondo buona prtaica clinica

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	NETSTAP e.V.

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-09-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-20

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2012-10-31

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials