Effect of BDP/FF/GB pMDI and GB pMDI at supra-therapeutic dose on the heart rate-corrected QT interval based on the Fridericia’s correction (QTcF). [ Time Frame: time 0 (pre-dose) to 24 hours ]
Placebo-adjusted change from baseline in QTc interval based on the Fridericia’s correction (ΔΔQTcF) after dosing CHF5993 pMDI (800/48/100 μg) and GB pMDI (100 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Assay sensitivity by demonstrating the effect of a single oral therapeutic dose of moxifloxacin on QTcF. [ Time Frame: time 0 (pre-dose) to 6 hours ]
Placebo-adjusted change from baseline in QTc interval based on the Fridericia’s correction (ΔΔQTcF) after dosing 400 mg of moxifloxacin. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on Hearth Rate (HR). [ Time Frame: time 0 (pre-dose) to 24 hours ]
Placebo-adjusted change from baseline of HR (ΔΔHR) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg) will be summarized by means of descriptive statistics at each analysis time point and by treatment. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on PR interval (PR). [ Time Frame: time 0 (pre-dose) to 24 hours ]
Placebo-adjusted change from baseline of PR (ΔΔPR) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg) will be summarized by means of descriptive statistics at each analysis time point and by treatment. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on QRS interval (QRS). [ Time Frame: time 0 (pre-dose) to 24 hours ]
Placebo-adjusted change from baseline of QRS (ΔΔQRS) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg) will be summarized by means of descriptive statistics at each analysis time point and by treatment. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on individual-corrected QT interval (QTcI) [ Time Frame: time 0 (pre-dose) to 24 hours ]
Placebo-adjusted change from baseline in individual-corrected QT interval (ΔΔQTcI) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Effect of moxifloxacin at therapeutic dose on individual-corrected QT interval. [ Time Frame: time 0 (pre-dose) to 6 hours ]
Placebo-adjusted change from baseline in individual-corrected QT interval (ΔΔQTcI) after dosing 400 mg of moxifloxacin. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Changes in T-wave morphology and U-wave presence. [ Time Frame: time 0 (pre-dose) to 24 hours ]
Frequency of treatment-emergent changes in T-wave morphology and U-wave presence after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Analysis of categorical outliers of Hearth Rate (HR), PR interval (PR), QRS interval (QRS) and QTcF interval (QTcF), after BDP/FF/GB pMDI dosing at therapeutic and supra-therapeutic dose, and after GB dosing at supra-therapeutic dose. [ Time Frame: time 0 (pre-dose) to 24 hours ]
Results of categorical outliers will be summarized by treatment in frequency tables reporting: counts and percentages for number of subjects and number of time points with 1) abnormal actual QTcF values, and 2) abnormal change from baseline of HR, PR, QRS and QTcF. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Analysis of Maximum plasma concentration (Cmax), pharmacokinetic parameter of FF, GB, BDP and B17MP [ Time Frame: time 0 (pre-dose) to 24 hours ]
Analysis of Cmax after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Analysis of Area under the curve from 0 to 12 hours post-dose (AUC0-12), pharmacokinetic parameter of FF, GB, BDP and B17MP [ Time Frame: time 0 (pre-dose) to 24 hours ]
Analysis of AUC0-12, after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Analysis of Area under the plasma concentration-time curve from time 0 to time t (AUC0 t), pharmacokinetic parameter of FF, GB, BDP and B17MP [ Time Frame: time 0 (pre-dose) to 24 hours ]
Analysis of AUC0-t after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Analysis of Area under the curve from time 0 to infinity (AUC0-∞), pharmacokinetic parameter of FF, GB, BDP and B17MP [ Time Frame: time 0 (pre-dose) to 24 hours ]
Analysis of AUC0-∞ after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Analysis of Time to maximum plasma concentration (tmax), pharmacokinetic parameter of FF, GB, BDP and B17MP [ Time Frame: time 0 (pre-dose) to 24 hours ]
Analysis of tmax, after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Analysis of Terminal half-life (t1/2), pharmacokinetic parameter of FF, GB, BDP and B17MP [ Time Frame: time 0 (pre-dose) to 24 hours ]
Analysis of t1/2, after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Incidence of Adverse events [ Time Frame: from study start through study completion, an average of 4 months ]
Number and percentage of subjects with at least one event and number of treatment emergent events
Incidence of Adverse Drug Reactions [ Time Frame: from study start through study completion, an average of 4 months ]
Number and percentage of subjects with at least one event and number of treatment emergent events
Change of systolic and diastolic blood pressure [ Time Frame: from study start through study completion, an average of 4 months ]
Number and percentage of subjects with with abnormal changes from baseline
Body temperature abnormal values [ Time Frame: from study start through study completion, an average of 4 months ]
Number and percentage of subjects with at least one event and number of treatment emergent events
Abnormal results of physical examinations [ Time Frame: from study start through study completion, an average of 4 months ]
Number and percentage of subjects with at least one event and number of treatment emergent events
Abnormal clinical chemistry and haematology laboratory tests [ Time Frame: from study start through study completion, an average of 4 months ]
Number and percentage of subjects with at least one event and number of treatment emergent events
Source: View full study details on ClinicalTrials.gov
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