Efficacy and Safety of Salmeterol/Fluticasone Propionate
Efficacy and Safety of Salmeterol/Fluticasone Propionate
Background and Objective: Salmeterol and fluticasone propionate are well established in the treatment of childhood asthma, and their combination is effective in children aged 4–11 years. Asthma guidelines recommend that the inhaler device best suited to the individual should be used to administer asthma treatment. The aim of this study was to further evaluate the efficacy of salmeterol/fluticasone propionate combination (SFC) delivered by the Diskus™ (50/100µg, one inhalation twice daily) and compare it with that observed when SFC is delivered by a chlorofluorocarbon-free pressurised metered-dose inhaler (pMDI) [25/50µg, two inhalations twice daily] in children aged 4–11 years with persistent asthma.
Patients and Methods: This equivalence study had a multicentre, randomised, double-blind, double-dummy, parallel-group design and comprised asthmatic children aged 4–11 years who required beclometasone (beclomethasone dipropionate) =500 µg/day (or equivalent). After a 2-week run-in using existing inhaled corticosteroid therapy, patients were randomised to receive SFC via Diskus™ (n?=?213) or pMDI (n = 215, with 82% using a spacer) for 12 weeks. Salbutamol (Ventolin) was provided for symptomatic relief. The primary endpoint was mean morning peak expiratory flow rate (PEF) recorded by patients during weeks 1–12. Secondary endpoints included other lung function parameters, day- and night-time symptoms, use of rescue medication and percentage of symptom- and salbutamol-free days. Adverse events and 12-hour overnight urinary cortisol concentrations were monitored to assess safety.
Results: Treatment with SFC, delivered by either device, was highly effective in improving patients' morning PEF and asthma symptoms. Over the whole study period, morning PEF (mean ± standard error) improved by 37.7 ± 3.1 L/min in the Diskus™ group and by 38.6 ± 3.0 L/min in the pMDI group. The -0.9 L/min difference between groups (95% CI -7.1, 5.4) was within the predefined criterion for equivalence of (i.e. -15, 15 L/min). The median percentage of symptom-free and rescue medication-free days and nights increased considerably in both groups. For all efficacy parameters assessed, improvement occurred for all age groups as early as weeks 1–4, and was sustained over the 12 weeks. Both Diskus™ and pMDI treatments were well tolerated and their safety profiles were comparable.
Conclusion: SFC delivered via Diskus™ or pMDI was shown to be highly effective in asthmatic children aged 4–11 years. Children as young as 4 years were able to use the Diskus™ and pMDI effectively. The combination is clinically equivalent when administered via either device in this patient population. This means that both Diskus™ and pMDI (+ spacer) are suitable for administration of SFC, which provides prescribers/users with a choice of device.
Asthma affects an estimated 4.8 million children worldwide and its prevalence and incidence in children is increasing. Long-acting ß2-agonist (LABA) and inhaled corticosteroid (ICS) therapy represent the cornerstone of asthma treatment. Many studies have shown that the addition of a LABA to an ICS is more effective than doubling the dose of ICS. The combination of salmeterol and fluticasone propionate (FP) is as effective as giving the two drugs concurrently via separate inhalers and significantly more effective, in terms of lung function and symptom control, than either drug given alone at the same nominal dosage. The combination is also significantly more effective than montelukast plus FP or monotherapy with inhaled budesonide. Furthermore, the combination is more cost effective than inhaled corticosteroid monotherapy. Therefore, concomitant LABA and ICS treatment is the most effective and preferred means of controlling symptoms in patients with moderate, persistent asthma, and this is reflected in national and international guidelines for the management of asthma.
Choice of delivery device may be just as important as choice of pharmacological agent in the treatment of asthma. Asthma guidelines recommend that the delivery device best suited to the individual patient should be used to administer treatment. The pressurised metered-dose inhaler (pMDI) is one of the most commonly prescribed delivery systems for the treatment of asthma. This device has a long history of effective, well tolerated delivery of inhaled medications. However, it demands a good technique from the patient for adequate delivery of the drug. The age range of those able to use pMDIs can be increased considerably by the use of a spacer device. The Diskus™ (GlaxoSmithKline, Middle-sex, UK) is a dry powder inhaler delivery device with a low inspiratory flow resistance, producing highly consistent drug delivery over a wide range of inspiratory flow rates. The advantages of the Diskus™ include ease of use, lack of requirement for hand-breath coordination, lack of a propellant (i.e. environmentally friendly), and consistent dosing.
Salmeterol and FP are well established in the treatment of childhood asthma, and treatment with these agents via the Diskus™ is effective in asthma patients aged 4–11 years. It is desirable for patients to have a choice of available delivery devices and, given the current treatment recommendations, this is particularly important in children. Against this background, the present study was performed to?comparatively evaluate the efficacy and safety profiles of salmeterol/FP combination (SFC) in children aged 4–11 years with persistent asthma following delivery by pMDI or Diskus™.
Background and Objective: Salmeterol and fluticasone propionate are well established in the treatment of childhood asthma, and their combination is effective in children aged 4–11 years. Asthma guidelines recommend that the inhaler device best suited to the individual should be used to administer asthma treatment. The aim of this study was to further evaluate the efficacy of salmeterol/fluticasone propionate combination (SFC) delivered by the Diskus™ (50/100µg, one inhalation twice daily) and compare it with that observed when SFC is delivered by a chlorofluorocarbon-free pressurised metered-dose inhaler (pMDI) [25/50µg, two inhalations twice daily] in children aged 4–11 years with persistent asthma.
Patients and Methods: This equivalence study had a multicentre, randomised, double-blind, double-dummy, parallel-group design and comprised asthmatic children aged 4–11 years who required beclometasone (beclomethasone dipropionate) =500 µg/day (or equivalent). After a 2-week run-in using existing inhaled corticosteroid therapy, patients were randomised to receive SFC via Diskus™ (n?=?213) or pMDI (n = 215, with 82% using a spacer) for 12 weeks. Salbutamol (Ventolin) was provided for symptomatic relief. The primary endpoint was mean morning peak expiratory flow rate (PEF) recorded by patients during weeks 1–12. Secondary endpoints included other lung function parameters, day- and night-time symptoms, use of rescue medication and percentage of symptom- and salbutamol-free days. Adverse events and 12-hour overnight urinary cortisol concentrations were monitored to assess safety.
Results: Treatment with SFC, delivered by either device, was highly effective in improving patients' morning PEF and asthma symptoms. Over the whole study period, morning PEF (mean ± standard error) improved by 37.7 ± 3.1 L/min in the Diskus™ group and by 38.6 ± 3.0 L/min in the pMDI group. The -0.9 L/min difference between groups (95% CI -7.1, 5.4) was within the predefined criterion for equivalence of (i.e. -15, 15 L/min). The median percentage of symptom-free and rescue medication-free days and nights increased considerably in both groups. For all efficacy parameters assessed, improvement occurred for all age groups as early as weeks 1–4, and was sustained over the 12 weeks. Both Diskus™ and pMDI treatments were well tolerated and their safety profiles were comparable.
Conclusion: SFC delivered via Diskus™ or pMDI was shown to be highly effective in asthmatic children aged 4–11 years. Children as young as 4 years were able to use the Diskus™ and pMDI effectively. The combination is clinically equivalent when administered via either device in this patient population. This means that both Diskus™ and pMDI (+ spacer) are suitable for administration of SFC, which provides prescribers/users with a choice of device.
Asthma affects an estimated 4.8 million children worldwide and its prevalence and incidence in children is increasing. Long-acting ß2-agonist (LABA) and inhaled corticosteroid (ICS) therapy represent the cornerstone of asthma treatment. Many studies have shown that the addition of a LABA to an ICS is more effective than doubling the dose of ICS. The combination of salmeterol and fluticasone propionate (FP) is as effective as giving the two drugs concurrently via separate inhalers and significantly more effective, in terms of lung function and symptom control, than either drug given alone at the same nominal dosage. The combination is also significantly more effective than montelukast plus FP or monotherapy with inhaled budesonide. Furthermore, the combination is more cost effective than inhaled corticosteroid monotherapy. Therefore, concomitant LABA and ICS treatment is the most effective and preferred means of controlling symptoms in patients with moderate, persistent asthma, and this is reflected in national and international guidelines for the management of asthma.
Choice of delivery device may be just as important as choice of pharmacological agent in the treatment of asthma. Asthma guidelines recommend that the delivery device best suited to the individual patient should be used to administer treatment. The pressurised metered-dose inhaler (pMDI) is one of the most commonly prescribed delivery systems for the treatment of asthma. This device has a long history of effective, well tolerated delivery of inhaled medications. However, it demands a good technique from the patient for adequate delivery of the drug. The age range of those able to use pMDIs can be increased considerably by the use of a spacer device. The Diskus™ (GlaxoSmithKline, Middle-sex, UK) is a dry powder inhaler delivery device with a low inspiratory flow resistance, producing highly consistent drug delivery over a wide range of inspiratory flow rates. The advantages of the Diskus™ include ease of use, lack of requirement for hand-breath coordination, lack of a propellant (i.e. environmentally friendly), and consistent dosing.
Salmeterol and FP are well established in the treatment of childhood asthma, and treatment with these agents via the Diskus™ is effective in asthma patients aged 4–11 years. It is desirable for patients to have a choice of available delivery devices and, given the current treatment recommendations, this is particularly important in children. Against this background, the present study was performed to?comparatively evaluate the efficacy and safety profiles of salmeterol/FP combination (SFC) in children aged 4–11 years with persistent asthma following delivery by pMDI or Diskus™.