Clinical Trials Register

Summary
EudraCT Number:	2008-004842-10
Sponsor's Protocol Code Number:	CCD-0809-PR-0038
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2008-11-14
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

France - ANSM

A.2

EudraCT number

2008-004842-10

A.3

Full title of the trial

A phase II, multinational, multicentre, double blind, double dummy, randomised, 5-way cross-over, placebo and active controlled clinical study to test the non-inferiority of a single dose of CHF 1535 (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg dry powder) via NEXT™ DPI 1 or 4 inhalations versus CHF 1535 (beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg) pMDI with HFA-134a propellant 1 or 4 puffs on FEV1 AUC0-12h in partly controlled adult asthmatic patients

A.4.1

Sponsor's protocol code number

CCD-0809-PR-0038

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	Chiesi Farmaceutici S.p.A.
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
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	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 NEXT(TM) DPI
D.3.2	Product code	CHF 1535 NEXT
D.3.4	Pharmaceutical form	Inhalation powder
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	beclometasone dipropionate
D.3.9.1	CAS number	5534-09-8
D.3.9.3	Other descriptive name	BDP
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	100
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.3.9.3	Other descriptive name	FF
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)	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	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	Foster
D.2.1.1.2	Name of the Marketing Authorisation holder	Chiesi Farmaceutici S.p.A
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.3.1	Product name	Foster 100/6 µg
D.3.2	Product code	CHF 1535 HFA-134a
D.3.4	Pharmaceutical form	Pressurised inhalation, solution
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	Beclomethasone dipropionate
D.3.9.1	CAS number	5534-09-8
D.3.9.3	Other descriptive name	BDP
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	100
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.3.9.3	Other descriptive name	FF
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)	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	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	Inhalation powder
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

Partly controlled asthma in adult patients

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10003553
E.1.2	Term	Asthma

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 the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT™ DPI (4 inhalations of beclomethasone dipropionate + formoterol fumarate, total dose: 400 + 24 µg) and CHF 1535 via HFA-134a “extrafine” pMDI (4 puffs of beclomethasone dipropionate + formoterol fumarate, total dose: 400 + 24 µg) and between a single dose of CHF 1535 via NEXT™ DPI (1 inhalation of beclomethasone dipropionate + formoterol fumarate, total dose: 100 + 6 µg) and CHF 1535 via HFA-134a “extrafine” pMDI (1 puff of beclomethasone dipropionate + formoterol fumarate, total dose: 100 + 6 µg) in partly controlled adult asthmatic patients.

E.2.2

Secondary objectives of the trial

To compare for each treatment, CHF 1535 via NEXT™ DPI and CHF 1535 via HFA-134a “extrafine” pMDI, the higher dose (400/24 µg) versus the lower dose (100/6 µg) in terms of FEV1 AUC0-12h,
- To evaluate the efficacy of the two treatments on pulmonary function in terms of FVC and peak FEV1,
- To evaluate the safety profile in terms of adverse events (AEs) and adverse drug reactions (ADRs) reporting, and vital signs.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for enrolment into the study:
1. Patient’s written informed consent obtained prior to any study-related procedures. Patients incapable of giving consent personally or vulnerable patients (except women of childbearing potential with acceptable method of contraception) cannot be included in the study.
2. Outpatient male or female aged ≥ 18 years.
3. Evidence for “partly controlled” asthma in the 2 weeks before the screening visit (during the pre-screening period) according to the Classification of Asthma Severity and Levels of Asthma Control of the Global Strategy for Asthma Management and Prevention (GINA guidelines 2006) i.e. one or more of the following: - daytime symptoms more than twice / week; - any limitations of activities or nocturnal symptoms / awakening; - need for reliever/rescue treatment more than twice / week.
4. Daily dose of previous inhaled corticosteroids (ICS) treatment at the screening visit:
a. ≤ 2000 µg of CFC BDP or BDP “non-extrafine”
b. ≤ 800 µg of BDP “extrafine” HFA
c. ≤ 1600 µg of budesonide
d. ≤ 1000 µg of fluticasone
e. ≤ 2000 µg of flunisolide
f. ≤ 1200 µg of mometasone
g. ≤ 1280 µg of ciclesonide
5. Forced expiratory volume in the first second (FEV1) ≥ 60% and ≤ 90% of the predicted normal values at the screening visit.
6. A documented positive response to the reversibility test at the screening visit, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, 30 minutes after 400 μg salbutamol pMDI (ATS/ERS taskforce 2005).
7. Patients free of long-acting beta 2-agonists (LABAs) treatment for at least 2 weeks before the screening visit.
8. Patients free of short-acting beta 2-agonists (SABAs) treatment for at least 6 hours before the screening visit.
9. Non-smokers or ex-smokers with a cumulative tobacco exposure less than 5 pack-years and who have stopped smoking for more than 1 year (pack-year: number of cigarettes smoked per day multiplied by the number of years of smoking divided by 20).
10. A cooperative attitude and ability to be trained in the proper use of a pMDI and a DPI.

E.4

Principal exclusion criteria

1. Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL or are using one or more of the following highly effective and acceptable methods of contraception.
a. surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)
b. hormonal contraception (implantable, injectable, patch, oral)
c. double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)

A urine pregnancy test will be performed at screening in women of childbearing potential.
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) within 1 year before screening.
4. Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit.
5. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (updated 2006).
6. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
7. Diagnosis of restrictive lung disease.
8. Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
9. Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids.
10. Allergy, sensitivity or intolerance to study drugs or excipients.
11. Patients who received any investigational new drug, or participated in clinical study within the last 8 weeks before the screening. The patients cannot participate in another clinical study as the same time as the present study.
12. Subjects unlikely to comply with the study protocol or unable to understand the nature and scope of the study but also the possible benefits or unwanted effects of the study treatments.
13. Significant 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.

E.5 End points

E.5.1

Primary end point(s)

FEV1 AUC0-12h standardised by time (FEV1 taken pre-dose at 10 min and post-dose at 10 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours and 12 hours).

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

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)

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

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

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

Yes

E.8.2.3

Other

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

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

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 months

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	25
F.4.2	For a multinational trial
F.4.2.1	In the EEA	65
F.4.2.2	In the whole clinical trial	65

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

2008-12-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-01-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-07-09

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