Patients with asthma or chronic obstructive pulmonary disease (COPD) can generate sufficient inspiratory flows via Easyhaler (R) dry powder inhaler : a pooled analysis of two randomized controlled trials

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Malmberg , L P , Pelkonen , A S , Vartiainen , V , Vahteristo , M , Lähelmä , S & Jogi , R 2021 , ' Patients with asthma or chronic obstructive pulmonary disease (COPD) can generate sufficient inspiratory flows via Easyhaler (R) dry powder inhaler : a pooled analysis of two randomized controlled trials ' , Journal of thoracic disease , vol. 13 , no. 2 , pp. 621-631 . https://doi.org/10.21037/jtd-20-2112

Title: Patients with asthma or chronic obstructive pulmonary disease (COPD) can generate sufficient inspiratory flows via Easyhaler (R) dry powder inhaler : a pooled analysis of two randomized controlled trials
Author: Malmberg, L. Pekka; Pelkonen, Anna S.; Vartiainen, Ville; Vahteristo, Mikko; Lähelmä, Satu; Jogi, Rain
Contributor organization: HUS Inflammation Center
Department of Dermatology, Allergology and Venereology
Date: 2021-02
Language: eng
Number of pages: 11
Belongs to series: Journal of thoracic disease
ISSN: 2072-1439
DOI: https://doi.org/10.21037/jtd-20-2112
URI: http://hdl.handle.net/10138/329428
Abstract: Background: To evaluate whether patients of varying ages and lung function with asthma or those with chronic obstructive pulmonary disease (COPD) can achieve sufficient inspiratory flows for effective use of the fixed-dose combination of salmeterol-fluticasone propionate and budesonide-formoterol dispensed with the Easyhaler (R) (EH) device-metered, multi-dose dry powder inhaler (DPI). Methods: A pooled analysis of two randomized, multicenter, crossover, open-label studies (NCT01424137; NCT009849061) was conducted to characterize inspiratory flow parameters across the EH, Seretide Diskus (DI) and Symbicort Turbuhaler (TH) inhalers in patients with asthma and/or COPD of varying severity. The primary endpoint was peak inspiratory flow (PIF) rate through the EH. Results: The intent-to-treat population comprised 397 patients; 383 patients were included in the per protocol (PP) population. The mean PIF (standard deviation) values through the EH in patients = 18 years of age with asthma and in those with COPD, were similar: 61.4 (11.5), 69.7 (13.5), and 61.9 (13.2) L/min, respectively. These flow rates correspond to pressure drops of 5.05 (1.80), 6.52 (2.34) and 5.19 (2.07) kPa, respectively. In total, 380 (99.2%) of patients in the PP population were able to generate a PIF rate through the EH of >= 30 L/min, which is required to enable consistent dose delivery from the DPI; there was a moderate direct association between age and PIF in younger patients with asthma, but this was inverse and less apparent in adult patients with asthma and/or those with COPD. Height and weight were also moderately correlated with PIF. Stronger associations with PIF were observed for some lung function parameters, particularly native PIF and forced inspiratory vital capacity. Conclusions: Over 99% of patients with asthma and/or COPD were able to inhale through the EH with an adequate PIF rate, irrespective of age, or severity of airway obstruction. This confirms that patients with asthma and/or COPD can achieve inspiratory flows via the EH DPI that are sufficient for its effective use.
Subject: Fixed-dose combination
inhalation device
drug delivery
peak inspiratory flow (PIF)
device performance
RATE DEPENDENCY
IN-VITRO
RATES
DISKUS
TURBUHALER(R)
COMBINATION
DEVICES
3121 General medicine, internal medicine and other clinical medicine
Peer reviewed: Yes
Rights: cc_by_nc_nd
Usage restriction: openAccess
Self-archived version: publishedVersion


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