The effect of roflumilast in addition to LABA/LAMA/ICS treatment in COPD patients

Backer, Wilfried De; Vos, Wim; Holsbeke, Cedric Van; Vinchurkar, Samir; Claes, Rita; Hufkens, Annemie; Parizel, Paul M.; Bedert, Lieven; Backer, Jan De

doi:10.1183/09031936.00011714

Cited by 39 publications

(36 citation statements)

References 5 publications

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“…Furthermore, FRI provides novel insights in the mode of action of new compounds that have effects that are hard to analyze via traditional lung function testing (De Backer et al. ; Vos et al. ).…”

Section: Introductionmentioning

confidence: 99%

Functional respiratory imaging, regional strain, and expiratory time constants at three levels of positive end expiratory pressure in an ex vivo pig model

Henderson

Molgat‐Seon²,

Vos

et al. 2016

Physiol Rep

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Heterogeneity in regional end expiratory lung volume (EELV) may lead to variations in regional strain (ε). High ε levels have been associated with ventilator‐associated lung injury (VALI). While both whole lung and regional EELV may be affected by changes in positive end‐expiratory pressure (PEEP), regional variations are not revealed by conventional respiratory system measurements. Differential rates of deflation of adjacent lung units due to regional variation in expiratory time constants (τ E) may create localized regions of ε that are significantly greater than implied by whole lung measures. We used functional respiratory imaging (FRI) in an ex vivo porcine lung model to: (i) demonstrate that computed tomography (CT)‐based imaging studies can be used to assess global and regional values of ε and τ E and, (ii) demonstrate that the manipulation of PEEP will cause measurable changes in total and regional ε and τ E values. Our study provides three insights into lung mechanics. First, image‐based measurements reveal egional variation that cannot be detected by traditional methods such as spirometry. Second, the manipulation of PEEP causes global and regional changes in R, E, ε and τ E values. Finally, regional ε and τ E were correlated in several lobes, suggesting the possibility that regional τ E could be used as a surrogate marker for regional ε.

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Section: Introductionmentioning

confidence: 99%

Functional respiratory imaging, regional strain, and expiratory time constants at three levels of positive end expiratory pressure in an ex vivo pig model

Henderson

Molgat‐Seon²,

Vos

et al. 2016

Physiol Rep

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“…FRI can be used to assess OIPs by comparing morphologic (airway volume and geometry) and ventilation changes in the segmented airways (up to the 7th generation) with clinical responses measured using conventional tests (115,116). With FRI, improvements in both airway volume and distribution of ventilation in responders to test drug have been shown (117). No data supporting the use of this approach to establish bioequivalence between a generic product and its innovator OIP are currently available.…”

Section: Future Developmentsmentioning

confidence: 99%

In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches

Forbes

Bäckman

Christopher

et al. 2015

AAPS J

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Abstract. This article is part of a series of reports from the "Orlando Inhalation Conference-Approaches in International Regulation" which was held in March 2014, and coorganized by the University of Florida and the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). The goal of the conference was to foster the exchange of ideas and knowledge across the global scientific and regulatory community in order to identify and help move towards strategies for internationally harmonized, science-based regulatory approaches for the development and marketing approval of inhalation medicines, including innovator and second entry products. This article provides an integrated perspective of case studies and discussion related to in vitro testing of orally inhaled products, including in vitro-in vivo correlations and requirements for in vitro data and statistical analysis that support quality or bioequivalence for regulatory applications.

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“…Many new treatments for COPD have been recently released or are about to be launched [11][12][13][14]. They include mostly new LABD, ICS and various combinations of these agents.…”

mentioning

confidence: 99%

Real-life use of long-acting antimuscarinic agents following their approval for COPD treatment

et al. 2014

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Chronic obstructive pulmonary disease (COPD) pharmacological treatment aims to reduce symptoms, represented mostly by dyspnoea and its impact on daily life, and future risk, i.e. lung function decline, mortality and exacerbations [1]. Inhaled therapies, including long-acting bronchodilators (LABD) and inhaled corticosteroids (ICS), are the main treatments recommended for COPD patients. LABD have been found not only to improve lung function, decrease dyspnoea, increase exercise tolerance and improve health status, but also to reduce the rate of exacerbations. In that respect, some studies suggested that long-acting antimuscarinic agents (LAMA) could be more effective than long-acting β 2 -agonists (LABA) [2]. In most countries, ICS are indicated only as part of fixed-dose combinations (FDC) with LABA and are used mostly to decrease the risk of exacerbations, which is associated with health status improvement [3]. Therefore, it appeared logical to restrict their use to patients at high risk of exacerbations. The long-term benefit of combining LAMA and FDC (triple therapy) is not strongly documented [4].

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The effect of roflumilast in addition to LABA/LAMA/ICS treatment in COPD patients

Cited by 39 publications

References 5 publications

Functional respiratory imaging, regional strain, and expiratory time constants at three levels of positive end expiratory pressure in an ex vivo pig model

Functional respiratory imaging, regional strain, and expiratory time constants at three levels of positive end expiratory pressure in an ex vivo pig model

In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches

Real-life use of long-acting antimuscarinic agents following their approval for COPD treatment

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