Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chiesi Farmaceutici S.p.A.
Age
5–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old
