Emitted dose estimates from Seretide® Diskus® and Symbicort® Turbuhaler® following inhalation by severe asthmatics

Tarsin, Walid; Pearson, S. Vere; Assi, K.H.; Chrystyn, Henry

doi:10.1016/j.ijpharm.2006.02.040

Cited by 74 publications

(44 citation statements)

References 19 publications

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“…The MMAD, GSD and FPF of labeled dose were 2.5, 1.9 and 30% with formoterol and 2.5, 1.9 and 35% with budesonide [59]. These results are substantially in accordance with other previously known, where the average MMAD, GSD and Fine Particle Dose of labeled dose were, respectively, 3.5, 1.5 and 18% for salmeterol and 3.6, 1.5 and 20% with fluticasone propionate using the Diskus; and 3.3, 1.6 and 11% with formoterol and 3.1, 1.6 and 13% with budesonide using the Turbuhaler [61].…”

Section: Alternative Reliever Treatments Include Inhaled Anticholinersupporting

confidence: 91%

Fluticasone propionate/formoterol: A fixed-combination therapy with flexible dosage

Papi

Blasi

Canonica

et al. 2014

European Journal of Internal Medicine

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International guidelines describe asthma control as the main outcome of asthma management. Prevention of symptoms, improved quality of life, and reduction of exacerbations are the main components, consequently decreasing health care costs. However, many of these objectives remain unmet in real life: several surveys show that a large proportion of asthmatic patients are not well controlled despite the efficacy of current available treatment. Several randomized controlled clinical trials indicate that combining inhaled corticosteroids and long-acting β 2 -agonists, by means of a single inhaler, greatly improves the management of the disease. The results of 9 multicenter phase III clinical studies demonstrate that the fixed combination of fluticasone propionate/formoterol in a single inhaler is effective in terms of lung function and symptom control. These studies highlight the dose flexibility, safety and tolerability of this new inhaled combination. These characteristics meet the recommendations of international guidelines, and the preferences of respiratory physicians who identified these aspects as critical components of a successful asthma therapy. Combination of fluticasone propionate/formoterol in a single inhaler provides potent anti-inflammatory activity of fluticasone propionate and rapid onset of action of the β 2 -agonist formoterol making this association a viable treatment option both in terms of effectiveness and compliance.

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Section: Alternative Reliever Treatments Include Inhaled Anticholinersupporting

confidence: 91%

Fluticasone propionate/formoterol: A fixed-combination therapy with flexible dosage

Papi

Blasi

Canonica

et al. 2014

European Journal of Internal Medicine

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“…(71) With most DPIs, the inhalation flow rate has a significant influence on the PSD. (72,73) For the Novolizer, a range of flow rates was selected to capture the inhalation profiles described in Table 1. The use of accurate inhalation profiles is also known to affect drug aerosol particle size and upper airway deposition.…”

Section: Determination Of Initial Aerosol Size Distributionmentioning

confidence: 99%

Validating Whole-Airway CFD Predictions of DPI Aerosol Deposition at Multiple Flow Rates

Longest

Tian

Khajeh-Hosseini-Dalasm

et al. 2016

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Background: The objective of this study was to compare aerosol deposition predictions of a new whole-airway CFD model with available in vivo data for a dry powder inhaler (DPI) considered across multiple inhalation waveforms, which affect both the particle size distribution (PSD) and particle deposition. Methods: The Novolizer DPI with a budesonide formulation was selected based on the availability of 2D gamma scintigraphy data in humans for three different well-defined inhalation waveforms. Initial in vitro cascade impaction experiments were conducted at multiple constant (square-wave) particle sizing flow rates to characterize PSDs. The whole-airway CFD modeling approach implemented the experimentally determined PSDs at the point of aerosol formation in the inhaler. Complete characteristic airway geometries for an adult were evaluated through the lobar bronchi, followed by stochastic individual pathway (SIP) approximations through the tracheobronchial region and new acinar moving wall models of the alveolar region. Results: It was determined that the PSD used for each inhalation waveform should be based on a constant particle sizing flow rate equal to the average of the inhalation waveform's peak inspiratory flow rate (PIFR) and mean flow rate [i.e., AVG(PIFR, Mean)]. Using this technique, agreement with the in vivo data was acceptable with <15% relative differences averaged across the three regions considered for all inhalation waveforms. Defining a peripheral to central deposition ratio (P/C) based on alveolar and tracheobronchial compartments, respectively, large flow-rate-dependent differences were observed, which were not evident in the original 2D in vivo data. Conclusions: The agreement between the CFD predictions and in vivo data was dependent on accurate initial estimates of the PSD, emphasizing the need for a combination in vitro-in silico approach. Furthermore, use of the AVG(PIFR, Mean) value was identified as a potentially useful method for characterizing a DPI aerosol at a constant flow rate.

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“…More recent work has suggested that when treatment reduction is indicated it is best to reduce the glucocorticoid dose rather than remove the LABA [134]. Currently, overall, there is no clear clinical evidence that suggests that one drug combination is better than the other in the short term [135] although differences in the device may be important in lung deposition in asthmatic patients with poor inspiratory flow [136] and treatment regimes may benefit some patients over others [125,133,137,138]. Indeed, the recent demonstration that the combination of formoterol/beclomethasone in a single inhaler is equivalent to formoterol/budesonide and salmeterol/ fluticasone with respect to asthma control, rates of asthma exacerbations and frequency of adverse events emphasises this point [139][140][141].…”

Section: Moderate Persistent Asthmamentioning

confidence: 99%

Inhaled corticosteroids as combination therapy with β-adrenergic agonists in airways disease: present and future

Chung

Caramori

Adcock

2009

Eur J Clin Pharmacol

119

106

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International audienceInhaled corticosteroid (ICS) therapy in combination with long-acting β-adrenergic agonists represents the most important treatment for chronic airways diseases such as asthma and chronic obstructive pulmonary disease (COPD). ICS therapy forms the basis for treatment of asthma of all severities, improving asthma control, lung function and preventing exacerbations of disease. Use of ICS has also been established in the treatment of COPD, particularly symptomatic patients, who experience useful gains in quality of life, likely from an improvement in symptoms such as breathlessness and in reduction in exacerbations, and an attenuation of the yearly rate of deterioration in lung function. The addition of long-acting β-agonist (LABA) therapy with ICS increases the efficacy of ICS effects in moderate-to-severe asthma. Thus, a 800 μg daily dose of the ICS budesonide reduced severe exacerbation rates by 49% compared to a low dose of 200 μg daily, and addition of the LABA formoterol to budesonide (800 μg) led to a 63% reduction. In COPD, the effects of ICS are less prominent but there are beneficial effects on the decline in FEV and the rate of exacerbations. A reduction in the rate of decline in FEV of 16 ml/year with a 25% reduction in exacerbation rate has been reported with the salmeterol and fluticasone combination. A non-significant 17.5% reduction in all-cause mortality rate with ICS and LABA is reported. Chronic inflammation is a feature of both asthma and COPD, although there are site and characteristic differences. ICS targets this inflammation although this effect of ICS is less effective in patients with severe asthma and with COPD; however, addition of LABA may potentiate the anti-inflammatory effects of ICS. An important consideration is the presence of corticosteroid insensitivity in these patients. Currently available ICS have variably potent binding activities to specific glucocorticoid receptors, leading to inhibition of gene expression by either binding to DNA and inducing anti-inflammatory genes or by repressing the induction of pro-inflammatory mediators. Local side effects of ICS include oral candidiasis, hoarseness and dysphonia, while systemic side effects, such as easy bruising and reduction in growth velocity or bone mineral densitometry, are usually restricted to doses above maximally recommended doses. Use of LABA alone in patients with asthma increases the risk of asthma-related events including deaths, but this is less observed with the combination of ICS and LABA. Therefore, use of LABA alone is not recommended for asthma therapy. Future progress in ICS development will be characterised by the introduction of ICS with greater efficacy with a limited side-effect profile, and by longer-acting ICS that can be used in combination with once-daily LABAs. Other agents that could improve the efficacy of corticosteroids or reverse corticosteroid insensitivity may be added to ICS. ICS in combination with LABAs will continue to remain the main focus of treatment of airways diseases

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Emitted dose estimates from Seretide® Diskus® and Symbicort® Turbuhaler® following inhalation by severe asthmatics

Cited by 74 publications

References 19 publications

Fluticasone propionate/formoterol: A fixed-combination therapy with flexible dosage

Fluticasone propionate/formoterol: A fixed-combination therapy with flexible dosage

Validating Whole-Airway CFD Predictions of DPI Aerosol Deposition at Multiple Flow Rates

Inhaled corticosteroids as combination therapy with β-adrenergic agonists in airways disease: present and future

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