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

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).

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