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Beclometasone Dipropionate

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Dave Singh – One of the best experts on this subject based on the ideXlab platform.

  • acute cardiovascular safety of two formulations of Beclometasone Dipropionate formoterol fumarate in copd patients a single dose randomised placebo controlled crossover study
    Pulmonary Pharmacology & Therapeutics, 2017
    Co-Authors: Dave Singh, A Muraro, Giorgia Ciurlia, Annalisa Piccinno, Maria Bocchi, Mario Scuri

    Abstract:

    Abstract Introduction An extrafine combination of Beclometasone Dipropionate (BDP) and formoterol fumarate (FF) via a pressurised metered-dose inhaler (pMDI) has been commercially available for some years for the management of asthma and chronic obstructive pulmonary disease (COPD). A dry powder inhaler (DPI) formulation of extrafine BDP/FF is now also available. This study evaluated the cardiovascular safety of BDP/FF DPI in comparison to BDP/FF pMDI and placebo. Methods Single-dose, partially-blind, randomised, placebo-controlled, 5-period crossover study. Main inclusion criteria: aged 40–75 years; moderate to severe COPD (post-bronchodilator FEV 1 40–80% predicted, FEV 1 /FVC Primary objective: to demonstrate non-inferiority between BDP/FF DPI and pMDI in average 4-h heart rate (HR 0–4h ) at each dose level. Secondary variables included: HR 0–12h , HR peak and individual timepoint; QTcF interval; SBP and DBP AUC 0–12h ; and potassium and glucose AUC 0–4h . Adverse events (AEs) were collected. Results Forty-nine patients were randomised; 45 (92%) received all five treatments. Non-inferiority was demonstrated between the DPI and pMDI formulations at both doses (−0.2 bpm [95% CI –1.3, 0.9] for 200/12 μg and 0.6 bpm [−0.5, 1.7] for 800/48 μg). Although there were statistically significant treatment-placebo differences at both doses and with both devices (thus confirming assay sensitivity), these differences were small and well below 5 bpm for the 200/12 μg dose. The results for the secondary parameters (QTcF, glucose and potassium) further supported the therapeutic equivalence of the two treatments. At the therapeutic dose, there were no clinically relevant treatment-placebo differences in any parameter with either formulation. There was no increase in the proportion of patients reporting AEs whilst receiving therapeutic doses of BDF/FF (either formulation) compared with placebo. Conclusions Overall, this study provides reassurance over the cardiovascular safety of extrafine BDP/FF, both in a DPI and a pMDI formulation.

  • Acute cardiovascular safety of two formulations of Beclometasone Dipropionate/formoterol fumarate in COPD patients: A single-dose, randomised, placebo-controlled crossover study.
    Pulmonary Pharmacology & Therapeutics, 2017
    Co-Authors: Dave Singh, A Muraro, Giorgia Ciurlia, Annalisa Piccinno, Maria Bocchi, Mario Scuri

    Abstract:

    Abstract Introduction An extrafine combination of Beclometasone Dipropionate (BDP) and formoterol fumarate (FF) via a pressurised metered-dose inhaler (pMDI) has been commercially available for some years for the management of asthma and chronic obstructive pulmonary disease (COPD). A dry powder inhaler (DPI) formulation of extrafine BDP/FF is now also available. This study evaluated the cardiovascular safety of BDP/FF DPI in comparison to BDP/FF pMDI and placebo. Methods Single-dose, partially-blind, randomised, placebo-controlled, 5-period crossover study. Main inclusion criteria: aged 40–75 years; moderate to severe COPD (post-bronchodilator FEV 1 40–80% predicted, FEV 1 /FVC Primary objective: to demonstrate non-inferiority between BDP/FF DPI and pMDI in average 4-h heart rate (HR 0–4h ) at each dose level. Secondary variables included: HR 0–12h , HR peak and individual timepoint; QTcF interval; SBP and DBP AUC 0–12h ; and potassium and glucose AUC 0–4h . Adverse events (AEs) were collected. Results Forty-nine patients were randomised; 45 (92%) received all five treatments. Non-inferiority was demonstrated between the DPI and pMDI formulations at both doses (−0.2 bpm [95% CI –1.3, 0.9] for 200/12 μg and 0.6 bpm [−0.5, 1.7] for 800/48 μg). Although there were statistically significant treatment-placebo differences at both doses and with both devices (thus confirming assay sensitivity), these differences were small and well below 5 bpm for the 200/12 μg dose. The results for the secondary parameters (QTcF, glucose and potassium) further supported the therapeutic equivalence of the two treatments. At the therapeutic dose, there were no clinically relevant treatment-placebo differences in any parameter with either formulation. There was no increase in the proportion of patients reporting AEs whilst receiving therapeutic doses of BDF/FF (either formulation) compared with placebo. Conclusions Overall, this study provides reassurance over the cardiovascular safety of extrafine BDP/FF, both in a DPI and a pMDI formulation.

  • single inhaler triple therapy versus inhaled corticosteroid plus long acting β2 agonist therapy for chronic obstructive pulmonary disease trilogy a double blind parallel group randomised controlled trial
    The Lancet, 2016
    Co-Authors: Dave Singh, Massimo Corradi, Mario Scuri, Alberto Papi, I Montagna, Stefano Vezzoli, G. Cohuet, Ilona Pavlisova, Catherine Francisco, Jorgen Vestbo

    Abstract:

    Summary Background Few data are available for the efficacy of “triple therapy” with two long-acting bronchodilators and an inhaled corticosteroid in chronic obstructive pulmonary disease (COPD). We designed this study to assess efficacy of single-inhaler combination of an extra fine formulation of Beclometasone Dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) in COPD compared with Beclometasone Dipropionate and formoterol fumarate (BDP/FF) treatment. Methods TRILOGY was a randomised, parallel group, double-blind, active-controlled study done in 159 sites across 14 countries. The sites were a mixture of primary, secondary, and tertiary care providers, and specialist investigation units. Eligible patients with COPD had post-bronchodilator forced expiratory volume in 1 s (FEV 1 ) of lower than 50%, one or more moderate-to-severe COPD exacerbation in the previous 12 months, COPD Assessment Test total score of 10 or more, and a Baseline Dyspnea Index focal score of 10 or less. Patients who met the inclusion and exclusion criteria at screening entered a 2-week open-label run-in period where they received Beclometasone Dipropionate (100 μg) and formoterol fumarate (6 μg) in two actuations twice daily. Patients were then randomly assigned (1:1) with an interactive response technology system to either continue BDP (100 μg) and FF (6 μg) or step-up to BDP (100 μg), FF (6 μg), and GB (12·5 μg) in two actuations twice daily for 52 weeks via pressurised metered-dose inhaler. The three co-primary endpoints were pre-dose FEV 1 , 2-h post-dose FEV 1 , and Transition Dyspnea Index (TDI) focal score, all measured at week 26 in the intention-to-treat population (all patients who were randomly assigned and received at least one dose of study drug and had at least one post-baseline efficacy assessment). Safety outcomes were measured in the safety population (all patients who were randomly assigned and received at least one dose of study drug). Secondary endpoints included moderate-to-severe COPD exacerbation rate over 52 weeks. This study is registered with ClinicalTrials.gov, number NCT01917331. Findings Between March 21, 2014, and Jan 14, 2016, 1368 patients received either BDP/FF/GB (n=687) or BDP/FF (n=681). At week 26, BDP/FF/GB improved pre-dose FEV 1 by 0·081 L (95% CI 0·052–0·109; p 1 by 0·117 L (0·086–0·147; p Interpretation We provide evidence for the clinical benefits of stepping up patients with COPD from an inhaled corticosteroid/long-acting β 2 -agonist combination treatment to triple therapy using a single inhaler. Funding Chiesi Farmaceutici SpA.

Daniela Acerbi – One of the best experts on this subject based on the ideXlab platform.

  • a two period open label single dose crossover study in healthy volunteers to evaluate the drug drug interaction between cimetidine and inhaled extrafine chf 5993
    European Journal of Drug Metabolism and Pharmacokinetics, 2017
    Co-Authors: Fabrizia Mariotti, A Muraro, Giorgia Ciurlia, Luca Spaccapelo, Daniela Acerbi

    Abstract:

    Background and Objectives
    CHF 5993 is an extrafine ‘triple therapy’ combination of the long-acting muscarinic antagonist glycopyrronium bromide (GB), the long-acting β2-agonist formoterol fumarate (FF), and the inhaled corticosteroid Beclometasone Dipropionate (BDP). It is in development for chronic obstructive pulmonary disease and asthma delivered via pressurised metered-dose inhaler.

  • Letter to the Editors
    , 2015
    Co-Authors: Nasim Sam, Daniela Acerbi, Hans Bisgaard

    Abstract:

    A clinical pharmacology study of fixed vs. free combination of inhaled Beclometasone Dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescent

  • pharmacokinetics and pharmacodynamics of an extrafine fixed pmdi combination of Beclometasone Dipropionate formoterol fumarate in adolescent asthma
    British Journal of Clinical Pharmacology, 2015
    Co-Authors: Piotr Kuna, Mario Scuri, Daniela Acerbi, Mirco Govoni, Germano Lucci, Iwona Stelmach

    Abstract:

    Aim
    The aim was to investigate the pharmacokinetics and pharmacodynamics of an extrafine pressurized metered-dose inhaler (pMDI) fixed combination of Beclometasone Dipropionate (BDP)/formoterol fumarate (FF) in adolescent and adult asthma.

    Methods
    This was a three-way crossover study, on 30 asthmatic adolescents receiving BDP/FF pMDI with or without a valved holding chamber (VHC) or a free licenced combination of BDP pMDI and FF pMDI plus a parallel arm of 30 asthmatic adults receiving BDP/FF pMDI. All patients received a single dose of BDP and FF of 400 µg and 24 µg, for each treatment, respectively. Assessments were performed over 8 hours.

    Results
    In adolescents, the 90% confidence intervals (CIs) for the systemic exposure (AUC(0,t)) geometric mean ratio of the fixed combination with or without VHC vs. the free combination were within the bioequivalence range 0.80–1.25, both for Beclometasone-17-monopropionate (B17MP, the active metabolite of BDP) and formoterol. Pharmacodynamic variables for plasma potassium and glucose, pulse rate and pulmonary function in adolescents were equivalent between treatments, 95% CI within 0.9, 1.09. The upper level of 90% CIs for AUC(0,t) geometric mean ratio adolescents : adults of B17MP and formoterol after treatment with BDP/FF pMDI was lower than 1.25, 90% CI 0.78, 1.04 and 0.86, 1.17, respectively.

    Conclusions
    In adolescents the pharmacodynamics and the overall systemic exposure to the active ingredients of an extrafine fixed combination of BDP/FF pMDI with or without a VHC was equivalent to that of a free licenced combination of pMDIs of established safety and efficacy profiles. The systemic exposure in adolescents was not higher than in adults. These results support the indication for use of inhaled corticosteroid/long acting β2-adrenoceptor agonist pMDIs in adolescents at the same dosage as in adults.

Mario Scuri – One of the best experts on this subject based on the ideXlab platform.

  • P276 Cardiovascular safety of extrafine single inhaler triple combination of Beclometasone Dipropionate, formoterol fumarate, and glycopyrronium bromide in copd: results of safety analysis from the trilogy and trinity studies
    Thorax, 2017
    Co-Authors: Mario Scuri, Massimo Corradi, Alberto Papi, I Montagna, Stefano Vezzoli, G. Cohuet, A Muraro, David Singh, C Francisco, Stefano Petruzzelli

    Abstract:

    Rationale COPD often co-exists with other chronic diseases that can contribute to patients’ health status and prognosis. In particular, patients with COPD are at greater risk of cardiovascular disease compared with age and sex-matched controls. Methods Two 52 week multi-centre, randomised, double-blind, active-controlled studies recruited patients with symptomatic COPD, severe to very severe airflow limitation, and an exacerbation history. In TRILOGY, patients were randomised (1:1) to an extrafine fixed triple combination of Beclometasone Dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB; 100/6/12.5 mcg, two actuations twice daily [BID] via pressurised metered dose inhaler [pMDI]; ‘fixed triple’) or an extrafine fixed combination of BDP/FF (100/6 mcg, two actuations BID via pMDI; Fostair) (Singh et al. Lancet 2016; 388: 963–73). In TRINITY patients were randomised 2:2:1 to BDP/FF/GB, tiotropium (18 mcg once daily via single-dose dry powder inhaler [SDDPI]), or BDP/FF+tiotropium: free triple (Vestbo et al. Lancet 2017; 389: 1919–29). In this analysis, we evaluated the occurrence of Major Adverse Cardiovascular Events (MACEs). MACEs included acute myocardial infarction, stroke, cardiovascular death, arrhythmias, and heart failure. Results MACE incidence and rate in the two BDP/FF/GB groups was similar to the BDP/FF and tiotropium groups (Table 1). The majority of reported MACEs were severe in intensity, with a slightly higher percentage of fatal events in the Tiotropium only group. Importantly, in patients with relevant concomitant cardiovascular diseases, the trend was similar to that seen in the overall populations. None of the other subgroup analyses (by age, spacer use and gender) highlighted relevant differences in the safety profiles compared with the overall population. Conclusions These Results provide further reassurance that the additional clinical benefits of this extrafine fixed triple compared to standard treatment are not associated with a greater impact on the cardiovascular safety in severe to very severe COPD patients, further supporting its positive benefit/risk ratio. Importantly, the presence of concomitant cardiac comorbidities did not influence the rate of cardiovascular events. Please refer to page A261 for declarations of interest in relation to abstract P276.

  • acute cardiovascular safety of two formulations of Beclometasone Dipropionate formoterol fumarate in copd patients a single dose randomised placebo controlled crossover study
    Pulmonary Pharmacology & Therapeutics, 2017
    Co-Authors: Dave Singh, A Muraro, Giorgia Ciurlia, Annalisa Piccinno, Maria Bocchi, Mario Scuri

    Abstract:

    Abstract Introduction An extrafine combination of Beclometasone Dipropionate (BDP) and formoterol fumarate (FF) via a pressurised metered-dose inhaler (pMDI) has been commercially available for some years for the management of asthma and chronic obstructive pulmonary disease (COPD). A dry powder inhaler (DPI) formulation of extrafine BDP/FF is now also available. This study evaluated the cardiovascular safety of BDP/FF DPI in comparison to BDP/FF pMDI and placebo. Methods Single-dose, partially-blind, randomised, placebo-controlled, 5-period crossover study. Main inclusion criteria: aged 40–75 years; moderate to severe COPD (post-bronchodilator FEV 1 40–80% predicted, FEV 1 /FVC Primary objective: to demonstrate non-inferiority between BDP/FF DPI and pMDI in average 4-h heart rate (HR 0–4h ) at each dose level. Secondary variables included: HR 0–12h , HR peak and individual timepoint; QTcF interval; SBP and DBP AUC 0–12h ; and potassium and glucose AUC 0–4h . Adverse events (AEs) were collected. Results Forty-nine patients were randomised; 45 (92%) received all five treatments. Non-inferiority was demonstrated between the DPI and pMDI formulations at both doses (−0.2 bpm [95% CI –1.3, 0.9] for 200/12 μg and 0.6 bpm [−0.5, 1.7] for 800/48 μg). Although there were statistically significant treatment-placebo differences at both doses and with both devices (thus confirming assay sensitivity), these differences were small and well below 5 bpm for the 200/12 μg dose. The results for the secondary parameters (QTcF, glucose and potassium) further supported the therapeutic equivalence of the two treatments. At the therapeutic dose, there were no clinically relevant treatment-placebo differences in any parameter with either formulation. There was no increase in the proportion of patients reporting AEs whilst receiving therapeutic doses of BDF/FF (either formulation) compared with placebo. Conclusions Overall, this study provides reassurance over the cardiovascular safety of extrafine BDP/FF, both in a DPI and a pMDI formulation.

  • Acute cardiovascular safety of two formulations of Beclometasone Dipropionate/formoterol fumarate in COPD patients: A single-dose, randomised, placebo-controlled crossover study.
    Pulmonary Pharmacology & Therapeutics, 2017
    Co-Authors: Dave Singh, A Muraro, Giorgia Ciurlia, Annalisa Piccinno, Maria Bocchi, Mario Scuri

    Abstract:

    Abstract Introduction An extrafine combination of Beclometasone Dipropionate (BDP) and formoterol fumarate (FF) via a pressurised metered-dose inhaler (pMDI) has been commercially available for some years for the management of asthma and chronic obstructive pulmonary disease (COPD). A dry powder inhaler (DPI) formulation of extrafine BDP/FF is now also available. This study evaluated the cardiovascular safety of BDP/FF DPI in comparison to BDP/FF pMDI and placebo. Methods Single-dose, partially-blind, randomised, placebo-controlled, 5-period crossover study. Main inclusion criteria: aged 40–75 years; moderate to severe COPD (post-bronchodilator FEV 1 40–80% predicted, FEV 1 /FVC Primary objective: to demonstrate non-inferiority between BDP/FF DPI and pMDI in average 4-h heart rate (HR 0–4h ) at each dose level. Secondary variables included: HR 0–12h , HR peak and individual timepoint; QTcF interval; SBP and DBP AUC 0–12h ; and potassium and glucose AUC 0–4h . Adverse events (AEs) were collected. Results Forty-nine patients were randomised; 45 (92%) received all five treatments. Non-inferiority was demonstrated between the DPI and pMDI formulations at both doses (−0.2 bpm [95% CI –1.3, 0.9] for 200/12 μg and 0.6 bpm [−0.5, 1.7] for 800/48 μg). Although there were statistically significant treatment-placebo differences at both doses and with both devices (thus confirming assay sensitivity), these differences were small and well below 5 bpm for the 200/12 μg dose. The results for the secondary parameters (QTcF, glucose and potassium) further supported the therapeutic equivalence of the two treatments. At the therapeutic dose, there were no clinically relevant treatment-placebo differences in any parameter with either formulation. There was no increase in the proportion of patients reporting AEs whilst receiving therapeutic doses of BDF/FF (either formulation) compared with placebo. Conclusions Overall, this study provides reassurance over the cardiovascular safety of extrafine BDP/FF, both in a DPI and a pMDI formulation.