Asthma in Children
Conditions
Keywords
asthma children NEXT DPI LABA ICS inhalation
Brief summary
This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.
Detailed description
Pharmacokinetic study in asthmatic children 5 to 11 years old treated with either a fixed combination of beclomethasone 50 ug/unit dose plus formoterol fumarate 6 ug/unit dose via the NEXT DPI dry powder inhaler or a free combination of Beclomethasone 100 ug DPI and Formoterol 6 ug DPI according to a cross-over design.
Interventions
free combination of beclomethasone dipropionate 100 ug/unit DPI (two inhalations, total dose 200 ug), and formoterol fumarate 6 ug/unit DPI (four inhalations, total dose 24 ug).
DRUGCHF 1535 50/6 NEXT DPI
four inhalations of CHF 1535 50/6 NEXT DPI, a fixed combination of beclomethasone dipropionate 50 ug plus formoterol fumarate 6 ug (TOTAL DOSE:BDP/FF 200/24 ug)
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
1. Male/Female children aged 5 -11y 2. Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting). 3. Children with stable asthma 4. Children with asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms 5. Forced expiratory volume in one second (FEV1) \> 70% of predicted values (% pred) after withholding beta2-agonists treatment for a minimum of 4 h prior to each study treatment. 6. A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures.
Exclusion criteria
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 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 | Description |
|---|---|---|
| B17MP (active metabolite of BDP) Area Under Curve (AUC) | predose, 15,30min, 1,2,4,6,8 hours post dose | B17MP: Profile of Pharmacokinetics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| B17MP Cmax,Tmax,T1/2 | predose, 15min,30min,1,2,4,6,8 hours post dose | BDP: profile of pharmacokinetics. |
| BDP Area Under Curve (AUC), Cmax, Tmax, T1/2 | predose, 15min,30min,1,2,4,6,8 hours postdose | BDP: profile of Pharmacokinetics |
| Heart Rate: Time averaged Heart Rate value: AUC0-t/t | predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose | Heart Rate to evaluate drug systemic effect |
| plasma potassium Area Under Curve (AUC), Cmin, Tmin | predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose | plasma potassium to evaluate drug systemic effect |
| Urinary Cortisol: Amount excreted in 0-8hours (Ae),8h cortisol urinary excretion normalized for 8h creatinine excretion (Ae/Aecreat). | from predose up to 8 hours postdose | Urinary cortisol to evaluate drug systemic effect |
| Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2 | predose, 15min, 30 min, 1,2,4,6,8 hours postdose | Formoterol: profile of pharmacokinetics |
Countries
Denmark
Outcome results
None listed