Asthma (patients aged 12-65 years) MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: CHF 1535 NEXT DPI
Product Code: CHF 1535
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Other descriptive name: BDP
Concentr
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adolescents (= 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 h in case of long acting ß2-agonist; 7. Non- or ex-smokers who smoked less than 5 pack-years and stopped smoking for at least 1 year; 8. Ability to a proper use of DPI devices (NEXT DPI®, Pulvinal® and Aerolizer®); 9. A cooperative attitude to be compliant with study procedures; 10. Body mass index (BMI) =18.5 and = 32 kg/m2 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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 ;Inclusion criteria: 1. Male and female adolescents (= 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 h in case of long acting ß2-agonist; 7. Non- or ex-smokers who smoked less than 5 pack-years and stopped smoking for at least 1 year; 8. Ability to a proper use of DPI devices (NEXT DPI®, Pulvinal® and Aerolizer®); 9. A cooperative attitude to be compliant with study procedures; 10. Body mass index (BMI) =18.5 and = 32 kg/m2 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: 1. Pregnant or lactating female. Sexually active female not using efficient contraception throughout the entire study period (e.g. oestroprogestatives, 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 1 months before the screening visit (Visit 1); 3. Diagnosis of COPD as defined by the current GOLD guidelines, update 2009; 4. 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; 5. Known hypersensitivity to the active treatments; 6. 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; 7. Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening; 8. Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit; 9. Inability to perform the required breathing technique and blood sampling; 10. Lower respiratory tract infection within 1 month prior to the screening visit; 11. Blood donation (450 mL or more) (for the adult population) or significant blood loss in the 12 weeks before the screening visit. ;Exclusion criteria: 1. Pregnant or lactating female. Sexually active female not using efficient contraception throughout the entire study period (e.g. oestroprogestatives, 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 1 months before the screening visit (Visit 1); 3. Diagnosis of COPD as defined by the current GOLD guidelines, update 2009; 4. 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; 5. Known hypersensitivity to the active treatments; 6. 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; 7. Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening; 8. Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit; 9. Inability to perform the required breathing technique and blood sampling; 10. Lower respiratory tract infection within 1 month prior to the screening visit; 11. 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 the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t, after four single inhalations of fixed combination CHF1535 100/6 NEXT DPI® (total dose: BDP 400 µg / FF 24 µg) in comparison with a free combination of BDP DPI and formoterol DPI licensed products in asthmatic adult and adolescent population.;Primary end point(s): Plasma AUC0-t for B17MP;Secondary Objective: - To evaluate the pharmacokinetic profile of BDP and formoterol and B17MP - To compare the systemic exposure to BDP/B17MP and formoterol - To evaluate lung function parameters, systemic effects (heart rate, plasma glucose, potassium and cortisol) and thus the general safety and tolerability profile of fixed combination CHF1535 100/6 NEXT DPI® in comparison with a free combination of BDP DPI and formoterol DPI licensed products ;Main Objective: To evaluate the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t, after four single inhalations of fixed combination CHF1535 100/6 NEXT DPI® (total dose: BDP 400 µg / FF 24 µg) in comparison with a free combination of BDP DPI and formoterol DPI licensed products in asthmatic adult and adolescent population.;Primary end point(s): Plasma AUC0-t for B17MP;Secondary Objective: - To evaluate the pharmacokinetic profile of BDP and formoterol and B17MP - To compare the systemic exposure to BDP/B17MP and formoterol - To evaluate lung function parameters, systemic effects (heart rate, plasma glucose, potassium and cortisol) and thus the general safety and tolerability profile of fixed combination CHF1535 100/6 NEXT DPI® in comparison with a free combination of BDP DPI and formoterol DPI licensed products | — |
Countries
United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed