WA, PC, HH and DS have no conflicts of interest to declare. HC: has received financial support to conduct research studies, for consultancy work and has received honoraria for presentations from several pharmaceutical companies that market inhaled products: Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Innovata Biomed, Meda, MundiPharma, Orion, Teva, Truddell Medical International, UCB and Zentiva. Research sponsorship has also been received from grant awarding bodies (EPSRC and MRC).
HC was the chief investigator and was involved with the design of the study and supervision of the data collection and data analysis. WA was involved with the design of the study, made all the measurements and was involved with the data analysis. PC, HH and DS were responsible for patient recruitment and management as well as direct supervision of WA at each clinical centre. All authors have contributed to, read and approved the final manuscript.
Spiromax® is a novel dry-powder inhaler containing formulations of budesonide plus formoterol (BF). The device is intended to provide dose equivalence with enhanced user-friendliness compared to BF Turbuhaler® in asthma and chronic obstructive pulmonary disease (COPD). The present study was performed to compare inhalation parameters with empty versions of the two devices, and to investigate the effects of enhanced training designed to encourage faster inhalation.
This randomised, open-label, cross-over study included children with asthma (n = 23), adolescents with asthma (n = 27), adults with asthma (n = 50), adults with COPD (n = 50) and healthy adult volunteers (n = 50). Inhalation manoeuvres were recorded with each device after training with the patient information leaflet (PIL) and after enhanced training using an In-Check Dial device.
After PIL training, peak inspiratory flow (PIF), maximum change in pressure (∆P) and the inhalation volume (IV) were significantly higher with Spiromax than with the Turbuhaler device (p values were at least <0.05 in all patient groups). After enhanced training, numerically or significantly higher values for PIF, ∆P, IV and acceleration remained with Spiromax versus Turbuhaler, except for ∆P in COPD patients. After PIL training, one adult asthma patient and one COPD patient inhaled <30 L/min through the Spiromax compared to one adult asthma patient and five COPD patients with the Turbuhaler. All patients achieved PIF values of at least 30 L/min after enhanced training.
The two inhalers have similar resistance so inhalation flows and pressure changes would be expected to be similar. The higher flow-related values noted for Spiromax versus Turbuhaler after PIL training suggest that Spiromax might have human factor advantages in real-world use. After enhanced training, the flow-related differences between devices persisted; increased flow rates were achieved with both devices, and all patients achieved the minimal flow required for adequate drug delivery. Enhanced training could be useful, especially in COPD patients.
Giraud V, Allaert FA. Improved asthma control with breath-actuated pressurized metered dose inhaler (pMDI): the SYSTER survey. Eur Rev Med Pharmacol Sci. 2009;13:323–30. PubMed
de Boer AH, Bolhuis GK, Gjaltema D, Hagedoorn P. Inhalation characteristics and their effect on the in-vitro drug delivery from dry powder inhalers. Part 3: the effect of flow increase rate (FIR) on the in-vitro drug release from the Pulmicort 200 Turbuhaler. Int J Pharm. 1997;153:67–77. CrossRef
Chrystyn H. Effects of device design on patient compliance: comparing the same drug in different devices. In: Dalby RN, Byron PR, Peart J, Suman JD, Young PM, River Grove IL, editors. Respiratory drug delivery. Europe: Davis Healthcare International; 2009. p. 105–16.
European Medicines Agency. EPAR summary for the public. DuoResp Spiromax budesonide / formoterol approval notification: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002348/WC500167184.pdf.
Azouz W, Chetcuti P, Hosker H, Saralaya D, Chrystyn H. Inhalation characteristics with Spiromax® (S) versus Turbuhaler® (T) dry powder inhalers (DPI) in healthy adults (HA) and in patients with asthma (A) or COPD. Eur Respir J. 2013;42 Supp 57:711.
Azouz W, Chetcuti P, Hosker H, Saralaya D, Chrystyn H. Enhanced training on how to use a dry powder inhaler (DPI) improves the inhalation manoeuvre (IM) of patients with asthma (child 6–17yrs and adult >17yrs) or COPD and in healthy adults (HA) when they use a Spiromax® (S) and Turbuhaler® (T) DPI. Eur Respir J. 2013;42 Suppl 57:693.
Chrystyn H, Azouz W, Chetcuti P, Saralaya D, Chrystyn H. Inhalation characteristics with Spiromax® and Turbuhaler® dry powder inhalers (DPI) in healthy adults and patients with asthma or chronic obstructive pulmonary disease (COPD): before and after enhanced training. Thorax. 2013;68 Suppl 3A:A178–9.
Chrystyn H, Azouz W, Chetcuti P, Hosker H, Saralaya D. Inhalation characteristics with Spiromax® and Turbuhaler® dry powder inhalers (DPI) in healthy adults and patients with asthma or chronic obstructive pulmonary disease (COPD): before and after enhanced training. Athens, Greece: Abstract presented at IPCR; 2014.
Rau JL. Practical problems with aerosol therapy in COPD. Respir Care. 2006;51:158–72. PubMed
Price D, Gopalan G, Shah T, Rehnstrom K, Kreuzaler S, Burden A, et al. A new methodology for assessing mastery and maintenance of dry powder inhaler technique in adults with asthma. Research Effectiveness Group (REG) Research Summit, London, UK, 28–29 June, 2014.
- Inhalation characteristics of asthma patients, COPD patients and healthy volunteers with the Spiromax® and Turbuhaler® devices: a randomised, cross-over study
- BioMed Central
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