Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old
A Single-dose, Open-Label, 2-Way Cross-Over, Clinical Pharmacology Study Of Chf 1535 50/6 HFA pMDI (Fixed Combination Of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6 µg) Using The Aerochamber Plus™ Spacer Device Versus The Free Combination Of Beclomethasone HFA pMDI And Formoterol HFA pMDI Available On The Market Using The Aerochamber Plus™ Spacer Device In Asthmatic Children
StatusCompleted No Results Posted
Intervention/Treatmentbeclomethasone formoterol chf1535 ...
The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).
Four inhalations for a total dose of BDP/FF 200/24 mcg
Four inhalations for a total dose of BDP 200 mcg
Four inhalations for a total dose of Formoterol 24 mcg
Fixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device
Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device
Inclusion Criteria: Male/Female children aged 5-11 years Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting). children with stable asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms Forced expiratory volume in one second (FEV1) > 70% of predicted values (% pred) after withholding beta2-agonist treatment for a minimum of 4 h prior to each dose period. 6. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device and compliant to study procedures. Exclusion Criteria: Past or present diagnoses of cardiovascular, renal or liver disease Known hypersensitivity to the active treatments Exacerbation of asthma symptoms within the previous 4 weeks Inability to perform the required breathing technique and blood sampling Hospitalization due to exacerbation of asthma within 1 month prior to inclusion Lower respiratory tract infection within 1 month prior to inclusion Disease (other than asthma) which might influence the outcome of the study Obesity, i.e. > 97% weight percentile by local standards