Advances in asthma and COPD management: Delivering CFC-free inhaled therapy using Modulite® technology

Acerbi, Daniela; Brambilla, G.; Kottakis, Ioannis

doi:10.1016/j.pupt.2006.05.005

Cited by 63 publications

(41 citation statements)

References 55 publications

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“…Inhalation therapy remains the cornerstone for the therapeutic management of asthma [1], [2], [3], [4]. Despite the availability of many inhaler devices with various design and formulation, the pressurised metered dose inhaler (pMDI) is still widely prescribed by the healthcare providers [5], [6].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of asthma control, parents’ quality of life and preference between AeroChamber Plus and AeroChamber Plus Flow-Vu spacers in young children with asthma

Ammari

Toor²,

Chetcuti

et al. 2014

Journal of Asthma

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Objective: The AeroChamber Plus (AC) valved holding chamber has been enhanced to include the Flow-Vu (FV) inspiratory flow indicator that provides visual inhalation feedback during use. We have investigated if FV alters asthma control and whether parents accept it.Methods: At visit 1 children with asthma, age 1-5 years, used an AC with their pressurised metered dose inhaler and 2 weeks later (visit 2) they were randomised to use either AC or FV. Subjects returned 6 (visit 3) and 12 (visit 4) weeks later. The Asthma Control (ACQ) and Paediatric Asthma Caregiver's Quality of Life (PACQLQ) questionnaires were scored at each visit and their peak inhalation flow (PIF) when they used their spacer was measured.Results: Forty participants in each group completed the study. There was no difference in the ACQ scores from visits 2 to 4 between the 2 groups, whilst the improvements in the PACQLQ scores were greater in the FV group (p=0.029). The mean difference (95% confidence interval) for the change from visits 2 to 4 between FV and AC groups was 0.05 (-0.33, 0.43) and 0.39 (0.035, 0.737) for the ACQ and PACQLQ, respectively. Most parents preferred the FV (p<0.001). There was no difference in the PIF rates at each visit and between the two spacers. Conclusions:There was no change in asthma control of the young children but that of their parents improved. Parents preferred the FV and this could be related to their improved perception of their children's asthma control by better PACQLQ scores.Parent preference for spacer with visual feedback

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Section: Introductionmentioning

confidence: 99%

Evaluation of asthma control, parents’ quality of life and preference between AeroChamber Plus and AeroChamber Plus Flow-Vu spacers in young children with asthma

Ammari

Toor²,

Chetcuti

et al. 2014

Journal of Asthma

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“…A fixed ICS/LABA combination pressurized metered dose inhaler (pMDI) containing extrafine beclometasone dipropionate (BDP 100 mg) and formoterol fumarate (6 mg) (Foster®, Chiesi Farmaceutici, Italy) has been recently developed using proprietary Modulite® (Chiesi Farmaceutici, Italy) technology [10]. This technology allows the drug particle size to be tailored, thus enabling the development of extra-fine formulations with an improved lung deposition [11]. A recent study [12], demonstrated that the extrafine beclometasone dipropionate/formoterol fixed dose combination was superior to separate components in asthma control.…”

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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“…(12) In addition, by tailoring the particle size, the Modulite Ò allows the development of extrafine formulations, replacing existing drugs at a reduced nominal dose. (13) For the same clinical effect, with BDP=formoterol HFA extrafine, the BDP dose is 2.5-fold lower than the conventional BDP chlorofluorocarbon (CFC) product: 400 mg BDP extrafine was clinically equivalent to 1000 mg of the reference BDP CFC formulation. (14,15) Each actuation of BDP=formoterol (100=6 mg) delivers 86.4 mg of BDP and 5 mg of formoterol.…”

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confidence: 99%

Lung Deposition of BDP/Formoterol HFA pMDI in Healthy Volunteers, Asthmatic, and COPD Patients

Backer

Devolder²,

Poli³

et al. 2010

Journal of Aerosol Medicine and Pulmonary Drug Delivery

153

121

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Background: When inhaling medication, it is essential that drug particles are delivered to all sites of lung inflammation, including the peripheral airways. The aim of this study was to assess the lung deposition and lung distribution of beclomethasone dipropionate (BDP)=formoterol (100=6 mg), both dissolved in hydrofluoroalkane (HFA) and delivered by pressurized metered dose inhaler (pMDI) in healthy subjects, asthmatic, and chronic obstructive pulmonary disease (COPD) patients, to investigate how the in vitro characteristics of the formulation translate into the in vivo performance in diseases with different airway obstruction.

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Advances in asthma and COPD management: Delivering CFC-free inhaled therapy using Modulite® technology

Cited by 63 publications

References 55 publications

Evaluation of asthma control, parents’ quality of life and preference between AeroChamber Plus and AeroChamber Plus Flow-Vu spacers in young children with asthma

Evaluation of asthma control, parents’ quality of life and preference between AeroChamber Plus and AeroChamber Plus Flow-Vu spacers in young children with asthma

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

Lung Deposition of BDP/Formoterol HFA pMDI in Healthy Volunteers, Asthmatic, and COPD Patients

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