ADONE: A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.

Sponsor

Chiesi Farmaceutici S.p.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT01191424

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

28.5

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a free combination of BDP DPI plus FF DPI licensed products after a morning dose administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic patients.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: CHF1535 NEXT DPI Drug: BDP DPI and formoterol DPI	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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 6 µg) Versus the Free Combination of Licensed Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescents and Adult Patients

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CHF1535 NEXT DPI Male and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI	Drug: CHF1535 NEXT DPI FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER
Active Comparator: Free combination BDP and FF Male and female adolescents and adult patients (≥ 12 years old) treated with a free combination of licenced BDP and FF	Drug: BDP DPI and formoterol DPI FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI

Arm

Intervention/Treatment

Experimental: CHF1535 NEXT DPI

Male and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI

Drug: CHF1535 NEXT DPI

FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER

Active Comparator: Free combination BDP and FF

Male and female adolescents and adult patients (≥ 12 years old) treated with a free combination of licenced BDP and FF

Drug: BDP DPI and formoterol DPI

FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI

Outcome Measures

Primary Outcome Measures

Systemic exposure to B17MP (active metabolite of BDP) after single dose (4 inhalations) of CHF1535 100/6 NEXT DPI in comparison with an already approved free combination of BDP DPI and FF DPI [0-8hrs]
Plasma AUC0-t for B17MP

Secondary Outcome Measures

Different pharmacokinetic parameters [0-8hrs]
BDP/B17MP and FF PK parameters
Lung function parameters [0-8hrs]
Peak FEV1, FEV1 time averaged value (FEV1 AUC0-t/8).
Plasma potassium [0-8hrs]
Plasma Potassium Cmin, tmin and AUC0-t
Plasma glucose [0-8hrs]
Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t
Heart rate [0-8hrs]
time averaged value (AUC0-t/8)
Adverse Events [during the whole study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Main Inclusion Criteria:

Male and female adolescents (≥ 12 years old) and adults (≥18 and ≤ 65 years old)
Written informed consent;
Diagnosis of asthma as defined in the GINA guidelines;
Patients with stable asthma, according to the Investigator's opinion;
Asthmatic patients already treated with ICS or using short-acting inhaled β2-agonists as reliever to control asthma symptoms;
Patients with a forced expiratory volume in one second (FEV1) > 70% of predicted values;
Patients with a peak inspiratory flow (PIF) > 40 L/min
Reversibility test;
Non- or ex-smokers;
A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures;

Main Exclusion Criteria:

Pregnant or lactating female;
Having received an investigational drug within 2 months before the screening visit
Diagnosis of COPD as defined by the current GOLD guidelines;
Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality;
Known hypersensitivity to the active treatments;
History of drug addiction or excessive use of alcohol;
Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening;
Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit;
Inability to perform the required breathing technique and blood sampling;
Lower respiratory tract infection within 1 month prior to the screening visit;
Blood donation (450 mL or more) or significant blood loss in the 12 weeks before the screening visit.