Clinical Trials Register

Summary
EudraCT Number:	2012-000039-22
Sponsor's Protocol Code Number:	CCD-1113-PR-0074
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-06-18
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

2012-000039-22

A.3

Full title of the trial

AN OPEN LABEL PLACEBO STUDY TO ASSESS THE INHALATION PROFILE OBTAINED BY ACOUSTIC MONITORING IN ASTHMATIC PATIENTS USING THE NEXTHALER DRY POWDER INHALER (DPI) DEVICE.

Studio in Aperto con Placebo in Pazienti Asmatici per Valutare il Profilo Inalatorio tramite Monitoraggio Acustico utilizzando l'inalatore NEXThaler a Polvere Secca

A.3.1

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

STUDY TO ASSESS THE INHALATION PROFILE OBTAINED BY ACOUSTIC MONITORING IN ASTHMATIC PATIENTS USING THE NEXTHALER INHALER

Studio per valutare il profilo inalatorio attraverso un monitoraggio acustico in pazienti con asma utilizzando l’inalatore Nexthaler

A.4.1

Sponsor's protocol code number

CCD-1113-PR-0074

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	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 S.p.A.
B.5.2	Functional name of contact point	NA
B.5.3	Address:
B.5.3.1	Street Address	Via PALERMO 26 A
B.5.3.2	Town/ city	PARMA
B.5.3.3	Post code	43100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0521-279717
B.5.5	Fax number	0521-279333
B.5.6	E-mail	c.tassi@chiesi.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 NEXThaler placebo
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Inhalation powder
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.3.9.3	Other descriptive name	CHF 1535 NEXThaler placebo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	Yes
D.3.11.13.1	Other medicinal product type	PLACEBO (LACTOSE MONOYDRATE 9.9 mg, PREBLEND (lactose magnesium stearate comicronized 0.2 %)

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

Adults asthmatics Patients with varying degrees of disease control.

Pazienti asmatici adulti con vari livelli di controllo della malattia

E.1.1.1

Medical condition in easily understood language

asthmatics Patients

Pazienti con 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	PT
E.1.2	Classification code	10003553
E.1.2	Term	Asthma
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

The primary objective of this study is to assess the inspiratory flow profile through the NEXThaler device in adult asthmatics with varying degrees of disease control.

L’obiettivo primario di questo studio e' di valutare il profilo del flusso inalatorio attraverso l’inalatore a polvere secca NEXThaler in pazienti asmatici adulti con vari livelli di controllo della malattia

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written informed consent obtained from the patient and/or the legal representatives 2. Inpatients and outpatients of both sexes, aged ≥ 18 years 3. Clinical diagnosis of controlled, partly controlled or uncontrolled asthma according to GINA guidelines (2011) 4. A cooperative attitude and ability to use DPIs and to be trained in the proper use of the NEXThaler as confirmed by the activation of the training device BAM

1. Consenso Informato scritto ottenuto dal paziente 2. Pazienti ricoverati e non, di entrambi I sessi, con etá ≥ 18 anni 3. Diagnosi clinica di asma controllata, parzialmente controllata o non controllata in accordo alle Linee guida GINA (2011) 4. Attitudine alla collaborazione e abilitá nell’uso del NEXThaler confermata dall’attivazione del BAM dell’apparecchio per il training

E.4

Principal exclusion criteria

1. Pregnant women confirmed by a positive pregnancy test or nursing (lactating) women (if applicable) 2. Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer 3. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit) 4. Diagnosis of restrictive lung disease Clinical Study Protocol No.: CCD-1113-PR-0074 Version No.: 1.0 EUDRACT No.: 2012-000039-22 Date: 30th March 2012 CONFIDENTIAL Page 7/30 5. Allergy to any component of the placebo treatment 6. Inability to comply with study procedures or treatment 7. Significant unstable medical history of 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

1. Donna in gravidanza confermata da un test di gravidanza positivo o donna in fase di allattamento 2. Significativa variazione stagionale dell’asma o asma che si manifesta solo durante esposizione episodica ad un allergene o a sostanza chimica 3. Storia clinica di asma quasi fatale (esempio: asma instabile, ospedalizzazione in Terapia Intensiva per esacerbazione di asma) 4. Diagnosi di malattia polmonare restrittiva 5. Allergia ai componenti del placebo 6. Incapacita' di aderire alle procedure dello studio o al trattamento 7. Anamnesi positiva per significativa instabilita’ clinica e/o in trattamento per malattie cardiache, renali, neurologiche, epatiche, endocrine, o ogni anormalita' di laboratorio indicativa di condizione patologica associata significativa che possa interferire con la sicurezza del paziente, adesione allo studio, o con le valutazioni dello studio secondo l’opinione dello sperimentatore

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

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

E.6.4

Safety

E.6.5

Efficacy

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

Exploratory study for assessing the inhalation profile

Studio esplorativo per valutare il profilo inalatorio

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

E.8.1.1

Randomised

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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.8.4.1

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

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

LPLV

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

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)

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

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.4.1

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)

Patients will continee with same treatments followed before their participation in the trial

I pazienti continueranno con le stesse terapie seguite prima della loro partecipazione

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

2012-06-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-15

P. End of Trial
P.	End of Trial Status	Completed

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