A MULTICENTER, MULTINATIONAL, SINGLE-DOSE, OPEN LABEL, RANDOMIZED, 2-WAY CROSSOVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 100/6 NEXT DPI® (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg) VERSUS THE FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI IN ASTHMATIC ADOLESCENTS AND ADULTS PATIENTS - ADONE

• Register: EUCTR
• Last refreshed on: 11 September 2012
• Main ID: EUCTR2010-018947-33-GB
• Date of registration: 01/07/2010
• Prospective Registration: Yes
• Primary sponsor: Chiesi Farmaceutici S.p.A.
• Public title: A MULTICENTER, MULTINATIONAL, SINGLE-DOSE, OPEN LABEL, RANDOMIZED, 2-WAY CROSSOVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 100/6 NEXT DPI® (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg) VERSUS THE FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI IN ASTHMATIC ADOLESCENTS AND ADULTS PATIENTS - ADONE
• Scientific title: A MULTICENTER, MULTINATIONAL, SINGLE-DOSE, OPEN LABEL, RANDOMIZED, 2-WAY CROSSOVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 100/6 NEXT DPI® (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg) VERSUS THE FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI IN ASTHMATIC ADOLESCENTS AND ADULTS PATIENTS - ADONE
• Date of first enrolment: 23/08/2010
• Target sample size: 59
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018947-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: yes Other trial design description: two cohorts of adolescent and adult patients If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male and female adolescents (= 12 and < 18 years old) and adults (=18
and = 65 years old);
2. Written informed consent obtained by the patient in case of adult
patients and by parents/legal representative and by the minor (according
to local regulation) prior to any study-related procedures;
3. Diagnosis of asthma as defined in the GINA guidelines, update 2009 in
the 6 months before the screening visit;
4. Patients with stable asthma enough, according to the Investigator’s
opinion, to allow a wash-out period from BDP and inhaled corticosteroids other than BDP of 2 and 1 day, respectively, before study treatments;
5. Asthmatic patients already treated with ICS or ICS/long-acting inhaled
ß2-agonists or using short-acting inhaled ß2-agonists as reliever to control asthma symptoms;
6. Patients with a forced expiratory volume in one second (FEV1) > 70% of
predicted values (% pred.) after withholding short acting ß2-agonist treatment for a minimum of 6 h prior to screening or 24 h in case of long acting ß2-agonist;
7. Non- or ex-smokers who smoked less than 5 pack-years and stopped
smoking for at least 1 year;
8. Ability to a proper use of DPI devices (NEXT DPI®, Pulvinal® and
Aerolizer®);
9. A cooperative attitude to be compliant with study procedures;
10. Body mass index (BMI) =18.5 and = 32 kg/m2
Are the trial subjects under 18? yes
Number of subjects for this age range:
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) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Pregnant or lactating female. Sexually active female not using efficient
contraception throughout the entire study period (e.g. oestroprogestatives,
condoms, intrauterine devices). A urinary pregnancy test will be performed at screening and treatment visits (mandatory in the adult population and at discretion of the investigator in the adolescent population) in women of childbearing potential;
2. Having received an investigational drug within 1 months before the
screening visit (Visit 1);
3. Diagnosis of COPD as defined by the current GOLD guidelines, update
2009;
4. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, that may interfere with patient’s safety, compliance, or study evaluations, according to the Investigator’s opinion;
5. Known hypersensitivity to the active treatments;
6. History of drug addiction or excessive use of alcohol (weekly intake in excess of 28 units alcohol; one unit being a glass of beer, wine or a measure of spirits), or excessive consumption of xanthine containing substances (daily intake in excess of 5 cups of coffee, tea, cola, etc) or psychological or other emotional problems likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements;
7. Treatment with a xanthine derivative (e.g. theophylline) formulation in
the 4 weeks prior to screening;
8. Hospitalization due to asthma exacerbation or asthma exacerbation
within 1 month prior to the screening visit;
9. Inability to perform the required breathing technique and blood
sampling;
10. Lower respiratory tract infection within 1 month prior to the screening visit;
11. Blood donation (450 mL or more) (for the adult population) or
significant blood loss in the 12 weeks before the screening visit.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Asthma (patients aged 12-65 years)
MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma

Intervention(s)

Product Name: CHF 1535 NEXT DPI
Product Code: CHF 1535
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Other descriptive name: BDP
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: FORMOTEROL FUMARATE
CAS Number: 43229-80-7
Other descriptive name: FF
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 6-

Trade Name: Pulvinal® Beclometasone Inhaler
Product Name: Pulvinal Beclometasone Inhaler
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Other descriptive name: BDP
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Foradil®
Product Name: Foradil Aerolizer
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: FORMOTEROL FUMARATE
CAS Number: 43229-80-7
Other descriptive name: FF
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 12-

Primary Outcome(s)

Secondary Objective: - To evaluate the pharmacokinetic profile of BDP and formoterol and B17MP
- To compare the systemic exposure to BDP/B17MP and formoterol
- To evaluate lung function parameters, systemic effects (heart rate, plasma
glucose, potassium and cortisol) and thus the general safety and tolerability profile of fixed combination CHF1535 100/6 NEXT DPI® in comparison with a free combination of BDP DPI and formoterol DPI licensed products

Main Objective: To evaluate the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t, after four single inhalations of fixed combination CHF1535 100/6 NEXT DPI® (total dose: BDP 400 µg / FF 24 µg) in comparison with a free combination of BDP DPI and formoterol DPI licensed products in asthmatic adult and adolescent population.

Primary end point(s): Plasma AUC0-t for B17MP

Secondary ID(s)

CCD-1017-PR-0034