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.
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.
Age
5–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
