Addition of salmeterol versus doubling the dose of fluticasone propionate in patients with mild to moderate asthma

Noord, J.A. van; Schreurs, A. J. M.; Mol, Stijn J.M.; Mulder, Paul

doi:10.1136/thx.54.3.207

Cited by 110 publications

(56 citation statements)

References 19 publications

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“…The fixed combination is at least as effective as both of its components are individually and has the advantage that only one inhaler has to be used by the patient, which is expected, although not proven, to increase adherence to therapy [38]. Furthermore, it has been indicated that addition of a long-acting b 2 -adreoceptor agonist to an inhaled steroid provides greater clinical advantage than doubling the dose of inhaled steroids in patients with symptomatic asthma [36,42]. The combination of both drugs in one inhaler influences neither the pharmacodynamic and pharmacokinetic characteristics nor the side-effect profiles of the individual substances [40].…”

Section: Combining Glucocorticoids and B 2 -Adrenoceptor Agonistsmentioning

confidence: 99%

Pharmacological treatment of asthma today: Table 1

Rabe¹,

Schmidt²

2001

Eur Respir J

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The current concept of asthma therapy is based on a stepwise approach, depending on disease severity, and the aim is to reduce the symptoms that result from airway obstruction and inflammation, to prevent exacerbations and to maintain normal lung function.b 2 -Adrenoceptor agonists and glucocorticoids are at present the most effective drugs for the treatment of airway obstruction and inflammation, with theophylline, leukotriene receptor antagonists and anticholinergics as second-or third-line therapy. There are, to date, no additional or newly developed drugs available that add substantially to the current strategies or even replace b 2 -adrenoceptor agonists or glucocorticoids. New approaches in asthma therapy recommend drug combinations of inhaled steroids, primarily with long-acting b 2 -adrenoceptor agonists, based on their improved efficacy and the potential for a steroid-sparing effect.Although existing drug entities are able to control the vast majority of patients with mild and moderate asthma, patients9 (and doctors9) adherence to guidelines and treatment strategies falls well short of the desired standards.Treatment choices, however, differ between countries and should take into account convenience to the patient and the occurrence of side-effects. Additionally, the cost of therapy and reimbursement policies also influences therapeutic strategies.

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Section: Combining Glucocorticoids and B 2 -Adrenoceptor Agonistsmentioning

confidence: 99%

Pharmacological treatment of asthma today: Table 1

Rabe¹,

Schmidt²

2001

Eur Respir J

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“…Inhaled corticosteroids and LABAs can be administered in combination to obtain additive clinical benefits, and there are also molecular interactions between these drugs that can lead to synergistic effects [3]. In asthmatic patients, LABA/ICS combinations produce greater improvements in lung function, symptom control and exacerbation rate reduction compared with doubling the dose of ICS [4][5][6][7][8]. Unfortunately, despite the widespread availability of these combination therapies, many patients with asthma remain poorly controlled [9].…”

Section: Introductionmentioning

confidence: 99%

Effect of AeroChamber Plus™ on the lung and systemic bioavailability of beclometasone dipropionate/formoterol pMDI

Singh

Collarini²,

Poli³

et al. 2011

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Use of a spacer minimizes oropharyngeal deposition and optimizes drug targeting to the airways in subjects with coordination difficulties. However, the increase in pulmonary deposition often observed with spacer devices, could potentially lead to an increase in overall systemic exposure.• EMA guidelines recommend that the development of a pMDI should always include testing of at least one specific spacer for use with a particular pMDI.• The aim of this study was to examine the effect of AeroChamber Plus™ on the lung bioavailability and total systemic exposure of a hydrofluoroalkane (HFA) pMDI fixed combination of extra‐fine beclometasone dipropionate/formoterol (100/6 µg) (Foster®).WHAT THIS STUDY ADDS• The use of AeroChamber Plus™ optimizes the lung delivery of beclometasone and formoterol in subjects that find it difficult to synchronize aerosol actuation with the inspiration of breath.• The total systemic exposure of beclometasone 17‐monopropionate and formoterol was not significantly increased by the use of the AeroChamber Plus™ spacer.• Use of the AeroChamber Plus™ spacer device with the extra‐fine beclometasone dipropionate/formoterol (100/6 µg) fixed combination pMDI can be a valuable option for certain patients groups, such as subjects with difficulties in achieving an adequate inhalation technique.AIM To assess the effect of AeroChamber Plus™ on lung deposition and systemic exposure to extra‐fine beclometasone dipropionate (BDP)/formoterol (100/6 µg) pMDI (Foster®). The lung deposition of the components of the combination given with the pMDI was also evaluated using the charcoal block technique.METHODS Twelve healthy male volunteers received four inhalations of extra‐fine BDP/formoterol (100/6 µg) using (i) pMDI alone, (ii) pMDI and AeroChamber Plus™ and (iii) pMDI and charcoal ingestion.RESULTS Compared with pMDI alone, use of AeroChamber Plus™ increased the peak plasma concentrations (Cmax) of BDP (2822.3 ± 1449.9 vs. 5454.9 ± 3197.1 pg ml−1), its active metabolite beclometasone 17‐monopropionate (17‐BMP) (771.6 ± 288.7 vs. 1138.9 ± 495.6 pg ml−1) and formoterol (38.4 ± 17.8 vs. 54.7 ± 20.0 pg ml−1). For 17‐BMP and formoterol, the AUC(0,30 min), indicative of lung deposition, was increased in the AeroChamber Plus™ group by 41% and 45%, respectively. This increase was mainly observed in subjects with inadequate inhalation technique. However, use of AeroChamber Plus™ did not increase the total systemic exposure to 17‐BMP and formoterol. Results after ingestion of charcoal confirmed that AUC(0,30 min) can be taken as an index of lung bioavailability and that more than 30% of the inhaled dose of extra‐fine BDP/formoterol 100/6 µg was delivered to the lung using the pMDI alone.CONCLUSIONS The use of AeroChamber Plus™ optimizes the delivery of BDP and formoterol to the lung in subjects with inadequate inhalation technique. The total systemic exposure was not increased, supporting the safety of extra‐fine BDP/formoterol pMDI with AeroChamber Plus™.

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“…Although increasing the dose of ICS can be a treatment option, the local and systemic adverse effects of high-dose ICS make this alternative less valuable [3, 4]. Therefore, the addition of a second treatment with a supplementary effect mechanism enables better asthma control [1, 2, 5, 6, 7, 8]. Recent studies have also supported the use of long-acting β 2 agonists and ICS together [6, 7, 8, 9, 10, 11].…”

Section: Introductionmentioning

confidence: 99%

Addition of Formoterol or Montelukast to Low-Dose Budesonide: An Efficacy Comparison in Short- and Long-Term Asthma Control

Ceylan

Gençer²,

Aksoy³

2004

Respiration

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Background: Asthma is a chronic inflammatory disease of the airways. Inhaled corticosteroids are very important in anti-inflammatory treatment, but to a great extent they cannot control asthma alone. In addition to corticosteroids, long-acting β₂ agonists and leukotriene antagonists are used for asthma control. Objective: In this study, the effect of the addition of formoterol and montelukast on asthma control in patients with moderately persistent asthma who were symptomatic while using a low dose of inhaled budesonide was compared. Methods: At the beginning of the study, 40 symptomatic patients with moderately persistent asthma used 400 µg/day budesonide for a 4-week training period, and were then divided randomly into two groups, each composed of 20 persons. For the first group’s treatment regime, inhaled formoterol (9 µg) twice a day was added, and for the second group’s treatment regime, one-dose oral montelukast (10 µg) was added. These patients were followed up for 8 weeks. The patients’ peak expiratory flow (PEF) values measured in the morning and at night, changes in PEF, forced expiratory volume in 1 s, asthma symptom score and the symptom-relieving therapy used during the 12-week study period were recorded and evaluated in the clinic at the very beginning and at the end of each period. Results: Before the study, the morning PEF value of the group for whom formoterol was added to budesonide (FB) was 266.3 ± 59.3 liters/min, and in the group for whom montelukast was added to budesonide (MB), it was 262.8 ± 53.8 liters/min (p > 0.05). After the 8-week treatment period, the morning PEF values were found to be 320.5 ± 54.4 liters/min in the FB group and 293.3 ± 52.4 liters/min in the MB group; at the end of the study, it was seen that although there was an increase in morning PEF of 54.2 ± 15.2 liters/min in the FB group, there was an increase of only 30.5 ± 25.3 liters/min in the MB group (p < 0.0001). Before the study, night PEF values were 287 ± 56.6 liters/min in the FB group and 283 ± 48.5 liters/min in the MB group (p > 0.05). At the end of the treatment, the night PEF values were found to be 331.5 ± 56.1 liters/min in the FB group and 310 ± 53.1 liters/min in the MB group. At the end of the study, it was observed that although there was an increase in night PEF of 44.5 ± 23.3 liters/min in the FB group, there was an increase of only 27 ± 24.1 liters/min in the MB group (p < 0.001). Although asthma symptom scores and the use of symptom-relieving drugs showed similarities between the two groups at the beginning of the study, after treatment, the FB group had better results than the MB group with respect to these two parameters (p < 0.0001 for both). It was also seen that the two treatments are tolerated equally well. Conclusion: FB treatment, which causes a considerable improvement in lung function, showed better asthma control than MB treatment in patients with moderately persistent asthma.

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Addition of salmeterol versus doubling the dose of fluticasone propionate in patients with mild to moderate asthma

Cited by 110 publications

References 19 publications

Pharmacological treatment of asthma today: Table 1

Pharmacological treatment of asthma today: Table 1

Effect of AeroChamber Plus™ on the lung and systemic bioavailability of beclometasone dipropionate/formoterol pMDI

Addition of Formoterol or Montelukast to Low-Dose Budesonide: An Efficacy Comparison in Short- and Long-Term Asthma Control

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