Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old

A Single-dose, Open-label, Randomized, 2-way Cross-over Study of CHF 1535 35/4 NEXThaler® (Fixed Combination of Beclometasone Dipropionate (BDP) 35 μg Plus Formoterol Fumarate (FF) 4 μg Versus the Free Combination of Licensed BDP DPI (Dry Powder Inhaler) and FF DPI in Asthmatic Children

The study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI) fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4 μg is compared with the free combination of licensed BDP DPI and FF DPI

This is a pharmacokinetic comparison of NEXThaler 35/4 μg versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.

Inclusion Criteria:

• Male/female children with asthma stable enough, according to paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments.
• Male/female children with asthma on regular treatment with ICS or using short-acting inhaled 2-agonist as reliever to control asthma symptoms.
• Age ≥ 5 < 12 years (8 to 10 children in the age range 5-8 years old).
• Children with a forced expiratory volume in one second (FEV1)>70% of predicted values (% pred) after withholding 2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment.
• A cooperative attitude and ability to be trained about the proper use of DPI, ability to use correctly the medical devices and compliant to study procedures

Exclusion Criteria:

• Past or present diagnosis of cardiovascular, renal or liver disease.
• Known hypersensitivity to the active treatmen
• Exacerbation of asthma symptoms within 4 weeks prior to screening.
• Inability to perform the required breathing technique and blood sampling.
• Hospitalization due to exacerbation of asthma within 1 month prior to screening (Visit 1).
• Lower respiratory tract infection within 1 month prior to screening (Visit 1).
• Disease (other than asthma) which might influence the outcome of the study.
• Obesity, i.e. > 97% weight percentile by local standards