asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Trimbow
Product Name: CHF 5993 pMDI
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Current Sponsor code: CHF71
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient’s and / or patient legal representative’s/parents’ (where applicable) written informed consent obtained prior to any study related procedure. 2. Ability to understand the study procedures, the risks involved, and ability to be trained to use the pMDI device correctly with AIM™ (Aerosol Inhalation Monitor) Vitalograph®. 3. Male and female adolescents, aged = 12 and 70% of predicted values (% pred) after withholding short acting ß2-agonist treatment for a minimum of 6h prior to screening or 24 hours in case of long acting ß2-agonist. 9. Non-smokers or ex-smokers who smoked 1 year prior to screening. 10. Good physical and mental status, determined on the basis of the medical history and a general clinical examination, at screening and at Visit 1 before dosing. 11. Female patients of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile) and female patients of childbearing potential (WOCBP) fulfilling one of the following criteria: a. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up visit or b. WOCBP with non-fertile male partners (contraception is not required in this case). Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Blood donation (equal or more than 450 ml) or blood loss, less than 2 months prior to screening or prior to Visit 1. 2. Abnormal haemoglobin level defined as 120 msec and/or PR > 210 msec and/or HR 110 bpm and/or QTcF > 450 ms for males or QTcF > 470 ms for females, considering the average from triplicate) or 12-lead ECG evaluated as abnormal clinically significant by the investigator, at screening. 15. Abnormal Blood Pressure (i.e.: Diastolic Blood Pressure > 90 mmHg and/or Systolic Blood Pressure > 140 mmHg, considering the average from triplicate) at screening. 16. Participation in another clinical trial with an investigational drug in the 30 days or 5 half-lives of that investigational drug (whichever is longer) preceding the administration of the study drug; a longer and more appropriate time could be considered by the principal investigator based on the elimination half-life and/or long-term toxicity of the previous investigational drug. 17. Patients taking enzyme-inducing drugs, enzyme-inhibiting drugs, biologic drugs or any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole) in the 3 months before screening or Visit 1. 18. Patients who have a high caffeine intake (> 5 caffeinated beverages e.g., coffee, tea, cola per day). 19. Patients who have had a lower respiratory tract infection (LRTI) within 4 weeks prior to screening or Visit 1. 20. Patients who are night shift workers with night shifts within 8 weeks prior to screening or Visit 1 and during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the systemic exposure to B17MP (active metabolite of BDP), formoterol and Glycopyrronium Bromide (GB) as AUC0-t, (index of total systemic exposure) after inhalation of CHF 5993 pMDI in adolescent asthmatic patients in comparison to adult asthmatic patients. ;Secondary Objective: ? To evaluate the pharmacokinetic profile of BDP and additional PK parameters of B17MP, formoterol and GB after inhalation of CHF 5993 pMDI in adolescent asthmatic patients in comparison to adult asthmatic patients. ? 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, formoterol and GB after inhalation of CHF 5993 pMDI in adolescent asthmatics.;Primary end point(s): The efficacy and safety endpoints are standard for evaluation of this drug class in Asthma and will allow to determine the effect of the IMP. Please refer to the protocol. ;Timepoint(s) of evaluation of this end point: Determination of Glycopyrronium Bromide levels in human plasma & Determination of potassium and glucose in human serum: Blood collection will occur prior to dosing and in the 0-10h interval after dosing, at following time points: pre-dose (within 75 min from dosing), 5, 15 and 30 min, 1, 2, 4, 8 and 10 hours post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The efficacy and safety endpoints are standard for evaluation of this drug class in Asthma and will allow to determine the effect of the IMP. Please refer to the protocol.;Timepoint(s) of evaluation of this end point: The efficacy and safety endpoints are standard for evaluation of this drug class in Asthma and will allow to determine the effect of the IMP. Please refer to the protocol. | — |
Countries
Poland
Contacts
Public ContactClinical Project Manager
Chiesi Farmaceutici S.p.A
Outcome results
None listed