Asthma
Conditions
Keywords
Asthma, PK, Adolescents, Adults
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.
Interventions
DRUGCHF1535 NEXT DPI
FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER
DRUGBDP DPI and formoterol DPI
FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. Male and female adolescents (≥ 12 years old) and adults (≥18 and ≤ 65 years old) 2. Written informed consent; 3. Diagnosis of asthma as defined in the GINA guidelines; 4. Patients with stable asthma, according to the Investigator's opinion; 5. Asthmatic patients already treated with ICS or using short-acting inhaled β2-agonists as reliever to control asthma symptoms; 6. Patients with a forced expiratory volume in one second (FEV1) \> 70% of predicted values; 7. Patients with a peak inspiratory flow (PIF) \> 40 L/min 8. Reversibility test; 9. Non- or ex-smokers; 10. A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures; Main
Exclusion criteria
1. Pregnant or lactating female; 2. Having received an investigational drug within 2 months before the screening visit 3. Diagnosis of COPD as defined by the current GOLD guidelines; 4. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality; 5. Known hypersensitivity to the active treatments; 6. History of drug addiction or excessive use of alcohol; 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) or significant blood loss in the 12 weeks before the screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Different pharmacokinetic parameters | 0-8hrs | BDP/B17MP and FF PK parameters |
| Heart rate | 0-8hrs | time averaged value (AUC0-t/8) |
| Adverse Events | during the whole study period | — |
| Plasma glucose | 0-8hrs | Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t |
Countries
Denmark, United Kingdom
Outcome results
None listed