Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old
- Conditions
- Asthma in Children
- Interventions
- Drug: CHF 1535 50/6 NEXT DPI
- Registration Number
- NCT01468272
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Male/Female children aged 5 -11y
- 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
- Children with 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-agonists treatment for a minimum of 4 h prior to each study treatment.
- A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures.
- 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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CHF 1535 NEXT DPI CHF 1535 50/6 NEXT DPI CHF 1535 50/6 NEXT DPI reference treatment free comb. beclomethasone DPI and formoterol DPI Free combination of Beclomethasone dipropionate DPI and Formoterol fumarate DPI
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method B17MP Cmax,Tmax,T1/2 predose, 15min,30min,1,2,4,6,8 hours post dose 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
Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2 predose, 15min, 30 min, 1,2,4,6,8 hours postdose Formoterol: profile of pharmacokinetics
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
BDP Area Under Curve (AUC), Cmax, Tmax, T1/2 predose, 15min,30min,1,2,4,6,8 hours postdose BDP: profile of Pharmacokinetics
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
Trial Locations
- Locations (1)
BørneAstmaKlinikken, Hans Knudsens Plads 1A,
🇩🇰Copenhagen,, Denmark