Authors
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Parenti, Selene, Singh, Dave, Chiesi Farmaceutici Spa, Global Clinical Development -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2024
INTERVENTION: This study will be composed of a 2‐week run‐in period with CHF5993 200/6/12.5 µg fixed combination of BDP 200 µg + FF 6 µg + GB 12.5 µg, via pMDI with HFA‐134a propellant (then refer as Reference product). This will be followed by a 12‐week treatment period with CHF5993 200/6/12.5 µg fixed combination of BDP 200 µg + FF 6 µg + GB 12.5 µg, via pMDI with HFA‐152a propellant (then refer as Test product) and Reference. Subjects will be centrally assigned through an IRT system to one of the two treatment arms in a 2:1 ratio for the Test product or Reference product An expected total duration of study participation (including pre‐screening/screening and follow‐up) is 16 weeks. In both treatment arms ( test and reference product ) the subject will be requested to take 2 inhalations twice daily (BID; i.e., 2 inhalations in the morning and 2 inhalations in the evening), with a total daily dose of BDP/FF/GB: 800/24/50 µg (subjects who inhale pMDI medications with a spacer should continue using the spacer AeroChamber Plus). The study involves a pre‐screening visit, a screening visit, and then a treatment phase with four on‐site visits, for up to 12 weeks. A follow‐up call will be done with subjects 7 to 10 days after a subject’s last intake of the study treatment to collect information on the subjects’ concomitant medications/procedures and adverse events (AEs). CONDITION: Asthma ; Respiratory PRIMARY OUTCOME: Potential for bronchoconstriction of each study treatment, defined as the relative change from pre‐dose in FEV1 at the 10 min post‐dose timepoint on Day 1 INCLUSION CRITERIA: 1. Male and female adults aged =18 and =75 2. Body mass inde X(BMI) within the range of 18.0 to 35.0 kg/m2 3. Physician‐diagnosed asthma >6 months and diagnosis before 50 years 4. Stable asthma therapy: a stable treatment with medium/high doses of ICS+LABA+LAMA (fixed or free combination) or medium/high doses of ICS+LABA (fixed or free combination) for at least 4 weeks before screening 5. Asthma control: controlled or partly controlled based on an Asthma Control Questionnaire (ACQ‐7) score <1.5 at screening and at randomization; 6. Pre‐bronchodilator 40% < FEV1 < 90% of their predicted normal value, after appropriate washout from bronchodilators, at the screening and randomization; 7. Subjects with a positive reversibility test at screening defined as an increase = 12% and/or 200 mL within 15‐20 minutes after inhalation of 400mcg salbutamol [ NOTE: in case the bronchodilator (BD) response threshold is not met at screening, the spirometry test can SECONDARY OUTCOME: 1. Relative change from pre‐dose in FEV1 at all the post‐dose timepoints at each study visit on Day 1, Day 7 and Week 12: 20 min, 30 min, 1 h and 2 h post‐dose Day 7, Week 4 and Week 12: 10 min post‐dose; 2. Absolute change from pre‐dose in FEV1 at all post‐dose timepoints at each study visit on Day 1, Day 7, and Week 12: 10 min, 20 min, 30 min, 1 h, and 2 h post‐dose Week 4: 10 min post‐dose; 3. Number and percentage of subjects with a relative decrease from pre‐dose in FEV1 at each post‐dose timepoint and at any post‐dose timepoint > 15% at each study visit on Day 1, Day 7, and Week 12: 10 min, 20 min, 30 min, 1 h, and 2 h post‐dose Week 4: 10 min post‐dose; 4. Absolute and relative changes from baseline i.e., pre‐dose* FEV1 at Day 1. in pre‐dose* FEV1 at all clinical visits; 5. Change from pre‐dose in FEV1 area under the curve from time zero to 2 h (AUC0‐2h. on Day 1, Day 7 and Week 12; 6. Change from baseline at each inter‐visit period and over the entire treatment period in morning and evening peak expiratory flow rate (PEF); 7. Change from baseline at each inter‐visit period and over the entire treatment period in the percentage of days without the intake of rescue medication; 8. Change from baseline at each inter‐visit period and over the entire treatment period in the average daily use of rescue medication (number of inhalations/day); 9. Change from baseline at each inter‐visit period and over the entire treatment period in the average daily symptoms ; 10. Change from baseline in ACQ‐7 at each study visit; 11. AEs and adverse drug reactions (ADRs); 12. AEs of particular interest: cough, dysphonia, paradoxical bronchospasm, hypersensitivity reactions, severe asthma exacerbations according to ATS/ERS criteria; 13. Vital signs (systolic and diastolic blood pressure); 14. 12‐lead ECG parameters: heart rate (HR), QTcF, PR interval (PR) and QRS interval (QRS); 15. 12‐lead ECG abnormalities ; 16. Standard haematology and blood chemistry (including serum potassium and plasma glucose); 17. Chemistry in urine (quantitative [proteins] and qualitative [ketones and microscopic examination of the sediments])
Epistemonikos ID: a914422e9054c23c9eb1759c5fdde6ea2f86790b
First added on: Aug 28, 2024