This study is focused on asthma bronchiale and chronic obstructive pulmonary disease COPD). MedDRA version: 9.1 Level: PT Classification code 10003553 Term: Asthma MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: CHF 1535 NEXT DPI
Product Code: CHF 1535 NEXT DPI
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Beclometasone Dipropionate
CAS Number: 5534098
Other descriptive name: BDP
C
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Healthy volunteers: 1.Males and females without childbearing potential aged 21-65 years; 2.Ability to use the NEXT(TM)DPI; 3.Body Mass Index (BMI) between 18.0 and 28.0 kg/m2; 4.Non- or ex-smokers who smoked 1 year; 5.Good physical and mental status, determined on the basis of the medical history and a general clinical examination; 6.Normal blood pressure and heart rate (100 = SBP = 150; 45 = DBP =90; 40 = HR = 100); 7.Electrocardiogram (ECG) (12 lead) with computerized protocol interpretation considered as normal (120 ms = PR = 220 ms, QRS = 120 ms, QTc = 450 ms). Minor deviations are acceptable provided the at they are not judged clinically significant by the investigator. 8.Results of laboratory tests within the normal ranges. Minor deviations are acceptable provided that they are not judged clinically significant by the investigator. 9.Understanding of the study and agreement to give written informed consent before the first selection procedure Patients with Asthma: 1.Males and females (without childbearing potential) asthma patients aged 21-65 years; 2.Ability to use the NEXT(TM)DPI; 3.Body Mass Index (BMI) between 18.0 and 28.0 kg/m2; 4.Non- or ex-smokers who smoked 1 year; 5.Normal blood pressure and heart rate (100 = SBP = 150; 45 = DBP =90; 40 = HR = 100); 6.ECG (12 lead) with computerized protocol interpretation considered as normal (120 ms = PR = 220 ms, QRS = 120 ms, QTc = 450 ms). Minor deviations are acceptable provided that they are not judged clinically significant by the investigator. 7.FEV1 = 30% and < 80% of predicted for the patient’s normal value (according to the predicted value for spirometric function, European Coal and Steel Community values [2]) measured at least 8 hours after the last use of short-acting ß2-agonist bronchodilators or short-acting anticholinergics, 72 hours after the last use of long-acting ß2-agonist bronchodilators and 72 hours after the last use of long-acting anticholinergics; 8.Reversibility of FEV1 = 12% and at least 200 ml of the initial value 15 minutes after inhalation of 200 µg Salbutamol within the screening period; 9.In good health on the basis of a medical history, physical examination, clinical laboratory studies and ECG with the exception of asthma; 10.Understanding of the study and agreement to give written informed consent before the first selection procedure. Patients with COPD: 1.Males and females without childbearing potential aged 40 – 70 years 2.Ability to use the NEXT(TM)DPI; 3.Body Mass Index (BMI) between 18.0 and 30.0 kg/m2; 4.Normal blood pressure and heart rate (100 = SBP = 150; 45 = DBP =90; 40 = HR = 100); 5.ECG (12 lead) with computerized protocol interpretation considered as normal (120 ms = PR = 220 ms, QRS= 120 ms, QTc= 450 ms). Minor deviations are acceptable provided that they are not judged clinically significant by the investigator; 6.Stable COPD within the past 4 weeks; 7.Post bronchodilator FEV1 between 30% and 50% predicted values (30% = FEV1 < 50%) documented at screening visit ; 8.Post bronchodilator FEV1/Forced Vital Capacity (FEV1/FVC) ? 0.70 (absolute value) documented at screening visit; 9.Minimum
Exclusion criteria
Exclusion criteria: Exclusion criteria All subjects: 1.Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication; 2.Positive HIV1 or HIV2 serology; 3.Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C; 4.Unsuitable veins for repeated venipuncture; 5.Female patients: pregnant, positive pregnancy test, lactating mother or lack of efficient contraception (according to CPMP/ICH 286/95 note 3 1). Postmenopausal women 0.70 (absolute value) and FEV1 and FVC > 80% for the European Community for Coal and Steel 1993 predicted values) or other standard values for healthy volunteers; Additional exclusion criteria for patients with Asthma: 1.Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months; 2.Life-threatening/unstable respiratory status including upper or lower respiratory tract infection, within the previous 30 days; 3.Requirement of continuous supplemental oxygen therapy; the use of supplemental oxygen not exceeding 2 l/min, at night time only and/or only during exercise is allowed; 4.Change in dose or type of any medications for asthma within 4 weeks prior to the screening visit; 5.Asthma exacerbation within the 4 weeks prior to inclusion. Additional exclusion criteria for patients with COPD: 1.Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months; 2.Life-threatening/unstable respiratory status including upper or lower respiratory tract infection, within the previous 30 days; 3.Requirement of continuous supplemental oxygen therapy; the use of supplemental oxygen not exceedi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To evaluate the amount of drug deposited within the lungs (intrapulmonary drug deposition relative to the nominal dose, DL, N) in healthy volunteers, asthmatic and COPD patients. ;Secondary Objective: Secondary: •To evaluate the intrapulmonary distribution and the extrathoracic deposition •To evaluate Formoterol, BDP and B17MP pharmacokinetics. •To evaluate the efficacy by lung function assessment ;Primary end point(s): Intrapulmonary lung deposition (DL, N) expressed as % of nominal dose | — |
Countries
Germany
Outcome results
None listed