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.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: CHF1535 NEXT DPI
* Drug: BDP DPI and formoterol DPI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF1535 NEXT DPI<br>Male and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI | Drug: CHF1535 NEXT DPI<br>* FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER<br>|
| Active Comparator: Free combination BDP and FF<br>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<br>* FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Plasma AUC0-t for B17MP | 0-8hrs | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, PK, Adolescents, Adults