Asthmatic children, aged 5-11, with a forced expiratory volume in one second (FEV1) > 70% of predicted values. MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: CHF 1535 50/6 HFA pMDI
Product Code: CHF 1535
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: beclomethasone dipropionate
CAS Number: 5534098
Concentration un
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting) prior to any study-related procedures. 2. Male/female children with asthma stable enough, according the paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments. 3.Male/female children with asthma on regular treatment with ICS or using short-acting inhaled beta2-agonist as reliever to control asthma symptoms 4. Age 5 -11y (about 50% of the children in the age range 5-8 years old) 5. Children with a forced expiratory volume in one second (FEV1) > 70% of predicted values (% pred). 6. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device and compliant to study procedures. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria The presence of any of the following will exclude a subject from study enrolment: 1. Past or present diagnoses of cardiovascular, renal or liver disease 2. Known hypersensitivity to the active treatments 3. Exacerbation of asthma symptoms within the previous 4 weeks 4. Inability to perform the required breathing technique and blood sampling 5. Hospitalization due to exacerbation of asthma within 1 month prior to inclusion 6. Lower respiratory tract infection within 1 month prior to inclusion 7. Disease (other than asthma) which might influence the outcome of the study 8. Obesity, i.e. > 97% weight percentile by local standards
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective(s). To evaluate, in children, the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t , after inhalation of CHF 1535 pMDI 50/6 with spacer device in comparison with an already approved free combination of BDP pMDI and formoterol pMDI with spacer device. ;Secondary Objective: Secondary Objective(s) - To evaluate the pharmacokinetic profile of BDP and formoterol (AUC0-t, AUC0-inf, Cmax, tmax and t½) and additional PK properties of B17MP (AUC0-0.5h, AUC0-inf, Cmax, tmax and t½) after inhalation of CHF1535 pMDI in comparison with a free combination of approved pMDIs; - To evaluate the systemic effects (plasma potassium, urinary cortisol excretion, urinary glucose and heart rate), and thus the general safety and tolerability profile, of BDP/B17MP and formoterol after single inhalation (4 puffs) of CHF 1535 HFA pMDI 50 + 6 µg. In addition, peak ekspiratory flow will be evaluated at the same time points of the PK evaluation. ;Primary end point(s): Primary endpoint The primary end-point will be B17MP AUC0-t (area under the concentration-time curve from time zero to the last measurable concentration). | — |
Countries
Denmark
Outcome results
None listed