Asthmatic children aged = 5 and < 12 years A part of the asthamatic children (8-10) must be in age range 5-8 years old in order to guarantee a complete representation. MedDRA version: 14.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: CHF 1535 50/6 microgram NEXT DPI
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Beclometasone dipropionate
CAS Number: 5534-09-8
Concentration unit: µg microgram(s)
Concentr
Sponsors
Chiesi Farmaceutici S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible for enrolment if they meet all of the following criteria: 1. Written informed consent obtained by Parent/Legal Representative (according to local regulation) and by the minor (age and local regulation permitting). 2. 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 3. Male/female children with asthma receiving regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms 4. Age = 5 70% of predicted values (% pred) after withholding ?2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment. 6. 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. Are the trial subjects under 18? yes Number of subjects for this age range: 26 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: Patients will not be enrolled if one or more of the following criteria are present: 1. Past or present diagnosis 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 screening (visit 1) 6. Lower respiratory tract infection within 1 month prior to screening (visit 1) 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: - To evaluate, in children, the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t , after inhalation of CHF 1535 NEXT DPI® in comparison with a free combination of licensed BDP DPI and formoterol DPI. ;Secondary Objective: Secondary: - To evaluate the pharmacokinetic profile of BDP and formoterol (AUC0-t, AUC0-inf, Cmax, tmax and t½) and B17MP (AUC0-inf, Cmax, tmax and t½) after inhalation of CHF1535 NEXT DPI® in comparison with a free combination of licensed BDP DPI and formoterol DPI. - 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 inhalation of CHF 1535 NEXT DPI® in comparison with a free combination of licensed BDP DPI and formoterol DPI. In addition, peak expiratory flow will be evaluated at the same time points of the PK evaluation. ;Primary end point(s): Plasma AUC0-t for B17MP.;Timepoint(s) of evaluation of this end point: End of trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetics: • Plasma BDP and formoterol AUC0-t, AUC0-inf, Cmax, tmax and t½ • Plasma B17MP, AUC0-inf, Cmax, tmax and t½ Pharmacodynamics: • Plasma Potassium Cmin, tmin and AUC0-t Efficacy: • PEF values evaluated at the same time points of the PK evaluation. Safety: • Ae/Aecreat: 8h urinary excretion of cortisol, normalized for 8h creatinine excretion (Aecreat). • Glucose concentration in urine • Heart Rate: Time averaged value (calculated as AUC0-8h/8h) General tolerability of the treatments, adverse events and adverse drug reactions. ;Timepoint(s) of evaluation of this end point: End of trial. | — |
Countries
Denmark
Contacts
Public ContactThorbjørn Jensen
Cyncron A/S
Outcome results
None listed