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

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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 ^® (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 and ≥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.

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Is Open Access

Inhaled Therapy in Respiratory Disease: The Complex Interplay of Pulmonary Kinetic Processes

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The inhalation route is frequently used to administer drugs for the management of respiratory diseases such as asthma or chronic obstructive pulmonary disease. Compared with other routes of administration, inhalation offers a number of advantages in the treatment of these diseases. For example, via inhalation, a drug is directly delivered to the target organ, conferring high pulmonary drug concentrations and low systemic drug concentrations. Therefore, drug inhalation is typically associated with high pulmonary efficacy and minimal systemic side effects. The lung, as a target, represents an organ with a complex structure and multiple pulmonary-specific pharmacokinetic processes, including (1) drug particle/droplet deposition; (2) pulmonary drug dissolution; (3) mucociliary and macrophage clearance; (4) absorption to lung tissue; (5) pulmonary tissue retention and tissue metabolism; and (6) absorptive drug clearance to the systemic perfusion. In this review, we describe these pharmacokinetic processes and explain how they may be influenced by drug-, formulation- and device-, and patient-related factors. Furthermore, we highlight the complex interplay between these processes and describe, using the examples of inhaled albuterol, fluticasone propionate, budesonide, and olodaterol, how various sequential or parallel pulmonary processes should be considered in order to comprehend the pulmonary fate of inhaled drugs.

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Author and article information

Journal

Journal ID (nlm-ta): J Thorac Dis

Journal ID (iso-abbrev): J Thorac Dis

Journal ID (publisher-id): JTD

Title: Journal of Thoracic Disease

Publisher: AME Publishing Company

ISSN (Print): 2072-1439

ISSN (Electronic): 2077-6624

Publication date (Print and electronic): February 2021

Publication date (Print): February 2021

Volume: 13

Issue: 2

Pages: 621-631

Affiliations

[1 ]Unit of Clinical Physiology, Skin and Allergy Hospital, Helsinki University and Helsinki University Hospital , Helsinki, Finland;

[2 ]Research and Development, Orion Corporation , Espoo, Finland;

[3 ]Lung Clinic, Tartu University Hospital , Tartu, Estonia

Author notes

Contributions: (I) Conception and design: All authors; (II) Administrative support: None; (III) Provision of study materials or patients: LP Malmberg, AS Pelkonen, R Jõgi; (IV) Collection and assembly of data: LP Malmberg, V Vartiainen, M Vahteristo, S Lähelmä; (V) Data analysis and interpretation: LP Malmberg, V Vartiainen, M Vahteristo, S Lähelmä; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

Correspondence to: Dr. L. Pekka Malmberg, MD, PhD. Unit of Clinical Physiology, Skin and Allergy Hospital, Helsinki University Central Hospital, PO Box 160, FIN00029 Helsinki, Finland. Email: pekka.malmberg@ 123456hus.fi .

[^]

ORCID: L. Pekka Malmberg, 0000-0001-5087-1160; Anna S. Pelkonen, 0000-0002-1482-8947; Ville Vartiainen, 0000-0002-9833-6965; Mikko Vahteristo, 0000-0001-9388-3997; Satu Lähelmä, 0000-0002-3189-8584; Rain Jõgi, 0000-0003-0869-6914.

Article

Publisher ID: jtd-13-02-621

DOI: 10.21037/jtd-20-2112

PMC ID: 7947512

PubMed ID: 33717535

SO-VID: b73de553-6dac-4b82-bc77-fd6b3f866570

License:

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0.

History

Date received : 02 June 2020

Date accepted : 18 November 2020

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