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

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