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.
- Conditions
- Asthma
- Interventions
- Drug: CHF1535 NEXT DPIDrug: BDP DPI and formoterol DPI
- Registration Number
- NCT01191424
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CHF1535 NEXT DPI CHF1535 NEXT DPI Male and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI Free combination BDP and FF BDP DPI and formoterol DPI Male and female adolescents and adult patients (≥ 12 years old) treated with a free combination of licenced BDP and FF
- Primary Outcome Measures
Name Time Method 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
Name Time Method Different pharmacokinetic parameters 0-8hrs BDP/B17MP and FF PK parameters
Adverse Events during the whole study period 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)
Trial Locations
- Locations (2)
Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
Medicines Evaluation Unit
🇬🇧Manchester, United Kingdom