Asthma MedDRA version: 14.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Foster®
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-08
Concentration unit: µg microgram(s)
Concentration type:
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adolescents, aged = 12 and 70% of predicted values (% pred) after withholding short acting ß2-agonist treatment for a minimum of 6 h prior to screening or 24 hours in case of long acting ß2-agonist. 7. Non- or ex-smokers who smoked less than 5 pack-years (e.g. =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding female patients. Sexually active female not using efficient contraception throughout the entire study period (e.g. oestro-progestatives, condoms, intrauterine devices). A urinary pregnancy test will be performed at screening and treatment visits (mandatory in the adult population and at discretion of the investigator in the adolescent population) in women of childbearing potential; 2. Having received an investigational drug within 2 months before the screening visit (Visit 1) 3. Diagnosis of COPD, in the adult patients, as defined by the current GOLD guidelines (updated 2010). 4. Known hypersensitivity to the active treatments. 5. Inability to perform the required breathing technique and blood sampling. 6. Hospitalization due to exacerbation of asthma within 1 month prior to screening visit. 7. Lower respiratory tract infection within 1 month prior to screening visit; 8. Obesity, i.e. > 97% weight percentile by local standards. 9. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, that may interfere with patient’s safety, compliance, or study evaluations, according to the Investigator’s opinion; 10. History of drug addiction or excessive use of alcohol (weekly intake in excess of 28 units alcohol; one unit being a glass of beer, wine or a measure of spirits), or excessive consumption of xanthine containing substances (daily intake in excess of 5 cups of coffee, tea, cola, etc) or psychological or other emotional problems likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements; 11. Treatment with a xanthine derivative (e.g. theophylline) formulations in the 4 weeks prior to screening visit; 12. Blood donation (450 mL or more) (for the adult population) or significant blood loss in the 12 weeks before the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate, in adolescents, the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t, after inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber Plus™) in comparison with the already licensed free combination of BDP pMDI and formoterol pMDI without spacer.;Secondary Objective: - To evaluate the pharmacokinetic profile of BDP and formoterol and additional PK properties of B17MP after inhalation of CHF 1535 100/6 pMDI both with and without spacer in comparison with a free combination of licensed BDP and Formoterol pMDIs. - To evaluate the systemic effects in terms of heart rate and circulating potassium and glucose levels and also the general safety and tolerability profile of BDP/B17MP and formoterol of CHF 1535 100/6 pMDI fixed combination both with and without spacer. - To evaluate, in adolescents, the effects of the spacer device (AeroChamber Plus™) on the systemic exposure to BDP/B17MP and formoterol after inhalation of the fixed combination. - To evaluate the systemic exposure to BDP/B17MP and formoterol after inhalation of CHF 1535 pMDI in adolescents in comparison to adults without the spacer device.;Primary end point(s): Plasma AUC0-t for B17MP;Timepoint(s) of evaluation of this end point: The area under the plasma concentration vs. time curve observed from time 0 up to the last measurable concentration will be computed using the linear trapezoidal rule [13]. An 8 hour value is required for derivation of AUC0-t. Nine (9) blood samples of approximately 1 mL for the determination of BDP and its metabolite B17MP in plasma will be collected in the 0-8 h interval after dosing [pre-dose (within 5 minutes from dosing), 5 min, 15 min, 30 min, 1, 2, 4, 6, 8 hours post dose]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetics: - Plasma BDP and formoterol AUC0-t, AUC0-inf , Cmax, tmax and t½ - Plasma B17MP AUC0-0.5h, AUC0-inf, Cmax, tmax and t½ Pharmacodynamics: - Plasma Potassium Cmin, tmin and AUC0-t - Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t Efficacy: - Peak FEV1, FEV1 time averaged value (FEV1 AUC0-8h/8h) Safety: - 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: PK - BDP/B17Mp/Formoterol in plasma at pre-dose, 5 min, 15 min, 30 min, 1, 2, 4, 6, 8 hours post dose PD - Potassium and Glucose at pre-dose, 30 min, 1, 2, 4, 6, 8 hours post dose; Safety - Heart rate will be measured at pre-dose, 5 min, 10 min, 15 min, 30 min, 1, 2, 4, 6, 8 hours post dose Efficacy - Lung function measurements (FEV1) at pre-dose, 30 min, 1, 2, 4, 6, 8 hours post dose | — |
Countries
Poland
Contacts
Public ContactChiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A.
Outcome results
None listed