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New pharmacologic perspectives in pneumology: beclomethasone-formoterol extrafine.

Paggiaro P - Open Respir Med J (2009)

Bottom Line: Combination therapy with inhaled corticosteroids (ICS) and long-acting-beta2-agonists (LABA) is recommended in a large part of asthmatic subjects (those who are not controlled with low-dose ICS alone).Recently, a new beclomethasone/formoterol combination in an extrafine HFA formulation has been developed.This new technology allows to obtain a very high fine particle fraction which reaches lower airways, while the dose which remain in the upper airways and possibly responsible for systemic side effects is very low.Therefore, this combination allows a different dose ratio between BDP and the other ICS (budesonide, fluticasone), in favour of a lower dose of BDP.

View Article: PubMed Central - PubMed

Affiliation: Cardio-Thoracic and Vascular Department, University of Pisa, Italy.

ABSTRACT
International asthma guidelines have recently focused on the concept of , which is the main outcome to reach and maintain in the long term management. Asthma control is associated with several positive consequences, both in terms of quality of life and pathophysiological findings. Combination therapy with inhaled corticosteroids (ICS) and long-acting-beta2-agonists (LABA) is recommended in a large part of asthmatic subjects (those who are not controlled with low-dose ICS alone).Recently, a new beclomethasone/formoterol combination in an extrafine HFA formulation has been developed. This new technology allows to obtain a very high fine particle fraction which reaches lower airways, while the dose which remain in the upper airways and possibly responsible for systemic side effects is very low. Therefore, this combination allows a different dose ratio between BDP and the other ICS (budesonide, fluticasone), in favour of a lower dose of BDP. Recent studies have demonstrated the equivalence of this new combination with the other ICS/LABA combination, as regards all asthma outcomes. Then, this new BDP/formoterol combination may increase the possibility to manage adequately patients with moderate-to-severe asthma.

No MeSH data available.


Related in: MedlinePlus

Increase from baseline in the Forced Vital Capacity (FVC) in subjects treated with the new beclomethasone/formoterol combination in extra-fine HFA formulation, in comparison with the traditional fluticasone/salmeterol combination. In both groups, FVC progressively increased, but this increase was significantly better with the new beclomethasone/formoterol combination [16].
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Figure 5: Increase from baseline in the Forced Vital Capacity (FVC) in subjects treated with the new beclomethasone/formoterol combination in extra-fine HFA formulation, in comparison with the traditional fluticasone/salmeterol combination. In both groups, FVC progressively increased, but this increase was significantly better with the new beclomethasone/formoterol combination [16].

Mentions: Two similar studies have been performed in order to show the non inferiority of this new combination in comparison with the other ICS-LABA combinations already present in the market. The first study compared the new BDP/formoterol in the extrafine HFA formulation with budesonide/formoterol combination; the dose ratio of BDP: Budesonide was 1:2, which is different from the traditional equivalence reported in the equivalence table of ICS in several international guidelines [2, 8-9]. In this study, more than 200 moderate asthmatic subjects, uncontrolled under ICS at doses lower than 1000 mcg of BDP or equivalent, were enrolled in a classic double blind randomised parallel group 3 month study [13]. The main outcome of the study was morning peak expiratory flow (PEF). In both groups, PEF significantly increased just after few weeks and remained higher than baseline during all the study period, without any significant difference between both groups (Fig. 4). The same efficacy was observed in the two groups as regards day-time and nocturnal symptoms, and the rate of asthma exacerbations. The second study used the same study design, comparing the new BDP/formoterol combination in extrafine HFA formulation with the fluticasone/salmeterol combination [14]. In this study, the dose ratio of BDP:fluticasone was 1:1.25, again different from the traditional equivalence reported in the equivalence table of ICS. The characteristics of the studied population was identical to the previous paper, as well as the main outcome (morning PEF). Also this study confirmed the equivalence between this new combination with the oldest fluticasone/salmeterol combination at different dose, in terms of pulmonary function, asthma symptoms and exacerbations. Furthermore, a significant better improvement in forced vital capacity (FVC) was observed with the new BDP/formoterol combination in comparison with fluticasone/salmeterol combination (Fig. 5). This observation suggests that the efficacy on may be better with the new BDP/Formoterol in the extrafine HFA formulation, due to the fine particle size of this combination.


New pharmacologic perspectives in pneumology: beclomethasone-formoterol extrafine.

Paggiaro P - Open Respir Med J (2009)

Increase from baseline in the Forced Vital Capacity (FVC) in subjects treated with the new beclomethasone/formoterol combination in extra-fine HFA formulation, in comparison with the traditional fluticasone/salmeterol combination. In both groups, FVC progressively increased, but this increase was significantly better with the new beclomethasone/formoterol combination [16].
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2682924&req=5

Figure 5: Increase from baseline in the Forced Vital Capacity (FVC) in subjects treated with the new beclomethasone/formoterol combination in extra-fine HFA formulation, in comparison with the traditional fluticasone/salmeterol combination. In both groups, FVC progressively increased, but this increase was significantly better with the new beclomethasone/formoterol combination [16].
Mentions: Two similar studies have been performed in order to show the non inferiority of this new combination in comparison with the other ICS-LABA combinations already present in the market. The first study compared the new BDP/formoterol in the extrafine HFA formulation with budesonide/formoterol combination; the dose ratio of BDP: Budesonide was 1:2, which is different from the traditional equivalence reported in the equivalence table of ICS in several international guidelines [2, 8-9]. In this study, more than 200 moderate asthmatic subjects, uncontrolled under ICS at doses lower than 1000 mcg of BDP or equivalent, were enrolled in a classic double blind randomised parallel group 3 month study [13]. The main outcome of the study was morning peak expiratory flow (PEF). In both groups, PEF significantly increased just after few weeks and remained higher than baseline during all the study period, without any significant difference between both groups (Fig. 4). The same efficacy was observed in the two groups as regards day-time and nocturnal symptoms, and the rate of asthma exacerbations. The second study used the same study design, comparing the new BDP/formoterol combination in extrafine HFA formulation with the fluticasone/salmeterol combination [14]. In this study, the dose ratio of BDP:fluticasone was 1:1.25, again different from the traditional equivalence reported in the equivalence table of ICS. The characteristics of the studied population was identical to the previous paper, as well as the main outcome (morning PEF). Also this study confirmed the equivalence between this new combination with the oldest fluticasone/salmeterol combination at different dose, in terms of pulmonary function, asthma symptoms and exacerbations. Furthermore, a significant better improvement in forced vital capacity (FVC) was observed with the new BDP/formoterol combination in comparison with fluticasone/salmeterol combination (Fig. 5). This observation suggests that the efficacy on may be better with the new BDP/Formoterol in the extrafine HFA formulation, due to the fine particle size of this combination.

Bottom Line: Combination therapy with inhaled corticosteroids (ICS) and long-acting-beta2-agonists (LABA) is recommended in a large part of asthmatic subjects (those who are not controlled with low-dose ICS alone).Recently, a new beclomethasone/formoterol combination in an extrafine HFA formulation has been developed.This new technology allows to obtain a very high fine particle fraction which reaches lower airways, while the dose which remain in the upper airways and possibly responsible for systemic side effects is very low.Therefore, this combination allows a different dose ratio between BDP and the other ICS (budesonide, fluticasone), in favour of a lower dose of BDP.

View Article: PubMed Central - PubMed

Affiliation: Cardio-Thoracic and Vascular Department, University of Pisa, Italy.

ABSTRACT
International asthma guidelines have recently focused on the concept of , which is the main outcome to reach and maintain in the long term management. Asthma control is associated with several positive consequences, both in terms of quality of life and pathophysiological findings. Combination therapy with inhaled corticosteroids (ICS) and long-acting-beta2-agonists (LABA) is recommended in a large part of asthmatic subjects (those who are not controlled with low-dose ICS alone).Recently, a new beclomethasone/formoterol combination in an extrafine HFA formulation has been developed. This new technology allows to obtain a very high fine particle fraction which reaches lower airways, while the dose which remain in the upper airways and possibly responsible for systemic side effects is very low. Therefore, this combination allows a different dose ratio between BDP and the other ICS (budesonide, fluticasone), in favour of a lower dose of BDP. Recent studies have demonstrated the equivalence of this new combination with the other ICS/LABA combination, as regards all asthma outcomes. Then, this new BDP/formoterol combination may increase the possibility to manage adequately patients with moderate-to-severe asthma.

No MeSH data available.


Related in: MedlinePlus