Asthma
Conditions
Brief summary
The study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI) fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4 μg is compared with the free combination of licensed BDP DPI and FF DPI
Detailed description
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.
Interventions
DRUGCHF 1535 35/4µg NEXThaler®
4 (four) inhalations (total dose: BDP/FF 140/16 µg)
2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg
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
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Area Under Curve (AUC0-t) for B17MP, active metabolite of BDP | predose, 15,30min, 1,2,4,6,8 hours post dose | B17MP: Profile of Pharmacokinetics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BDP Area Under Curve (AUC) | predose, 15min,30min,1,2,4,6,8 hours post dose | BDP: profile of Pharmacokinetics |
| Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2 [ | predose, 15min, 30 min, 1,2,4,6,8 hours postdose | Formoterol: profile of pharmacokinetics |
| Formoterol Cmax | predose, 15min, 30 min, 1,2,4,6,8 hours postdose | Formoterol: profile of pharmacokinetics |
| Formoterol Tmax | predose, 15min, 30 min, 1,2,4,6,8 hours postdose | Formoterol: profile of pharmacokinetics |
| Formoterol T1/2 | predose, 15min, 30 min, 1,2,4,6,8 hours postdose | Formoterol: profile of pharmacokinetics |
| plasma potassium Area Under Curve (AUC) | predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose | plasma potassium to evaluate drug systemic effect |
| plasma potassium Cmin | predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose | plasma potassium to evaluate drug systemic effect |
| B17MP Cmax | predose, 15min,30min,1,2,4,6,8 hours post dose | 17MP: 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 |
| B17MP Tmax | predose, 15min,30min,1,2,4,6,8 hours post dose | BDP: profile of pharmacokinetics |
| B17MP T1/2 | predose, 15min,30min,1,2,4,6,8 hours post dose | BDP: profile of pharmacokinetics |
| BDP Cmax | predose, 15min,30min,1,2,4,6,8 hours post dose | BDP: profile of pharmacokinetics |
| BDP Tmax | predose, 15min,30min,1,2,4,6,8 hours post dose | BDP: profile of pharmacokinetics |
| BDP T1/2 | predose, 15min,30min,1,2,4,6,8 hours post dose | BDP: profile of pharmacokinetics |
| plasma potassium Tmin | predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose | plasma potassium to evaluate drug systemic effect |
Countries
Denmark
Outcome results
None listed