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Extrafine beclomethasone/formoterol compared to fluticasone/salmeterol combination therapy in COPD.

Singh D, Nicolini G, Bindi E, Corradi M, Guastalla D, Kampschulte J, Pierzchała W, Sayiner A, Szilasi M, Terzano C, Vestbo J, FUTURE (Foster Upgrades TherapeUtic care in REspiratory disease) study gro - BMC Pulm Med (2014)

Bottom Line: Secondary endpoints included lung function, symptom scores, symptom-free days and use of rescue medication, St. George's Respiratory Questionnaire, six minute walking test and COPD exacerbations.There were no significant differences between treatments in secondary outcome measures, confirming overall comparability in terms of efficacy and tolerability.Moreover, a clinically relevant improvement (>4 units) in SGRQ was detected in the BDP/FF group only.

View Article: PubMed Central - HTML - PubMed

Affiliation: University of Manchester, Medicines Evaluation Unit, University Hospital of South Manchester Foundation Trust, Manchester, UK. DSingh@meu.org.uk.

ABSTRACT

Background: The study evaluated the efficacy of beclomethasone dipropionate/formoterol fumarate (BDP/FF) extrafine combination versus fluticasone propionate/salmeterol (FP/S) combination in COPD patients.

Methods: The trial was a 12-week multicentre, randomised, double-blind, double dummy study; 419 patients with moderate/severe COPD were randomised to BDP/FF 200/12 μg or FP/S 500/50 μg twice daily. The primary objective was to demonstrate the equivalence between treatments in terms of Transition Dyspnoea Index (TDI) score and the superiority of BDP/FF in terms of change from pre-dose in the first 30 minutes in forced expiratory volume in the first second (FEV1). Secondary endpoints included lung function, symptom scores, symptom-free days and use of rescue medication, St. George's Respiratory Questionnaire, six minute walking test and COPD exacerbations.

Results: BDP/FF was equivalent to FP/S in terms of TDI score and superior in terms of FEV1 change from pre-dose (p < 0.001). There were no significant differences between treatments in secondary outcome measures, confirming overall comparability in terms of efficacy and tolerability. Moreover, a clinically relevant improvement (>4 units) in SGRQ was detected in the BDP/FF group only.

Conclusion: BDP/FF extrafine combination provides COPD patients with an equivalent improvement of dyspnoea and a faster bronchodilation in comparison to FP/S.

Trial registration: ClinicalTrials.gov: NCT01245569.

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Related in: MedlinePlus

Change in FEV1. (a) Change from pre-dose in FEV1 (L) measured at baseline; (b) Change from pre-dose in FEV1 (L) measured at week 12. FEV1, forced expiratory volume in the first second; BDP/FF, beclomethasone dipropionate/formoterol fumarate; FP/S, fluticasone propionate/salmeterol. p < 0.001 at each time point compared to baseline pre-dose for both treatments and at each visit. ***p < 0.001 between treatments.
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Figure 3: Change in FEV1. (a) Change from pre-dose in FEV1 (L) measured at baseline; (b) Change from pre-dose in FEV1 (L) measured at week 12. FEV1, forced expiratory volume in the first second; BDP/FF, beclomethasone dipropionate/formoterol fumarate; FP/S, fluticasone propionate/salmeterol. p < 0.001 at each time point compared to baseline pre-dose for both treatments and at each visit. ***p < 0.001 between treatments.

Mentions: The AUC0-30min adjusted means (95% CI) were 0.18 L (0.16-0.19) and 0.11 L (0.09-0.12) for the BDP/FF and FP/S groups respectively, with a statistically significant difference between groups of 0.07 L (0.05-0.10; p < 0.001). Similarly, in patients with FEV1 < 50% of predicted the difference between groups was 0.08 L (0.05-0.10, p < 0.001). Figure 3 shows that FEV1 improved significantly at 5, 15 and 30 minutes post-dose in both treatment groups (p < 0.001 at all-time points). The improvements were significantly greater after BDP/FF compared to FP/S group at all timepoints (p < 0.001); the mean (95% CI) differences at 5, 15 and 30 minutes were 0.08 (0.06-0.11); 0.07 (0.04-0.10) and 0.07 (0.04-0.10), respectively.


Extrafine beclomethasone/formoterol compared to fluticasone/salmeterol combination therapy in COPD.

Singh D, Nicolini G, Bindi E, Corradi M, Guastalla D, Kampschulte J, Pierzchała W, Sayiner A, Szilasi M, Terzano C, Vestbo J, FUTURE (Foster Upgrades TherapeUtic care in REspiratory disease) study gro - BMC Pulm Med (2014)

Change in FEV1. (a) Change from pre-dose in FEV1 (L) measured at baseline; (b) Change from pre-dose in FEV1 (L) measured at week 12. FEV1, forced expiratory volume in the first second; BDP/FF, beclomethasone dipropionate/formoterol fumarate; FP/S, fluticasone propionate/salmeterol. p < 0.001 at each time point compared to baseline pre-dose for both treatments and at each visit. ***p < 0.001 between treatments.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4008134&req=5

Figure 3: Change in FEV1. (a) Change from pre-dose in FEV1 (L) measured at baseline; (b) Change from pre-dose in FEV1 (L) measured at week 12. FEV1, forced expiratory volume in the first second; BDP/FF, beclomethasone dipropionate/formoterol fumarate; FP/S, fluticasone propionate/salmeterol. p < 0.001 at each time point compared to baseline pre-dose for both treatments and at each visit. ***p < 0.001 between treatments.
Mentions: The AUC0-30min adjusted means (95% CI) were 0.18 L (0.16-0.19) and 0.11 L (0.09-0.12) for the BDP/FF and FP/S groups respectively, with a statistically significant difference between groups of 0.07 L (0.05-0.10; p < 0.001). Similarly, in patients with FEV1 < 50% of predicted the difference between groups was 0.08 L (0.05-0.10, p < 0.001). Figure 3 shows that FEV1 improved significantly at 5, 15 and 30 minutes post-dose in both treatment groups (p < 0.001 at all-time points). The improvements were significantly greater after BDP/FF compared to FP/S group at all timepoints (p < 0.001); the mean (95% CI) differences at 5, 15 and 30 minutes were 0.08 (0.06-0.11); 0.07 (0.04-0.10) and 0.07 (0.04-0.10), respectively.

Bottom Line: Secondary endpoints included lung function, symptom scores, symptom-free days and use of rescue medication, St. George's Respiratory Questionnaire, six minute walking test and COPD exacerbations.There were no significant differences between treatments in secondary outcome measures, confirming overall comparability in terms of efficacy and tolerability.Moreover, a clinically relevant improvement (>4 units) in SGRQ was detected in the BDP/FF group only.

View Article: PubMed Central - HTML - PubMed

Affiliation: University of Manchester, Medicines Evaluation Unit, University Hospital of South Manchester Foundation Trust, Manchester, UK. DSingh@meu.org.uk.

ABSTRACT

Background: The study evaluated the efficacy of beclomethasone dipropionate/formoterol fumarate (BDP/FF) extrafine combination versus fluticasone propionate/salmeterol (FP/S) combination in COPD patients.

Methods: The trial was a 12-week multicentre, randomised, double-blind, double dummy study; 419 patients with moderate/severe COPD were randomised to BDP/FF 200/12 μg or FP/S 500/50 μg twice daily. The primary objective was to demonstrate the equivalence between treatments in terms of Transition Dyspnoea Index (TDI) score and the superiority of BDP/FF in terms of change from pre-dose in the first 30 minutes in forced expiratory volume in the first second (FEV1). Secondary endpoints included lung function, symptom scores, symptom-free days and use of rescue medication, St. George's Respiratory Questionnaire, six minute walking test and COPD exacerbations.

Results: BDP/FF was equivalent to FP/S in terms of TDI score and superior in terms of FEV1 change from pre-dose (p < 0.001). There were no significant differences between treatments in secondary outcome measures, confirming overall comparability in terms of efficacy and tolerability. Moreover, a clinically relevant improvement (>4 units) in SGRQ was detected in the BDP/FF group only.

Conclusion: BDP/FF extrafine combination provides COPD patients with an equivalent improvement of dyspnoea and a faster bronchodilation in comparison to FP/S.

Trial registration: ClinicalTrials.gov: NCT01245569.

Show MeSH
Related in: MedlinePlus