Inhalation characteristics of asthma patients, COPD patients and healthy volunteers with the Spiromax® and Turbuhaler® devices: a randomised, cross-over study.
BACKGROUND
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Division of Pharmacy, School of Applied Sciences, University of Huddersfield, Huddersfield, UK. wahidaazzouz@yahoo.com.
Wahida
W
Azouz
Paediatrics, Leeds General Infirmary, Leeds, UK. Philip.Chetcuti@leedsth.nhs.uk.
Philip
P
Chetcuti
Department of Respiratory, Airedale General Hospital, Steeton, Bradford, UK. Harold.Hosker@anhst.nhs.uk.
Harold
H
Hosker
Department of Respiratory, Bradford Royal Infirmary, Bradford, UK. Dinesh.Saralaya@bthft.nhs.uk.
Dinesh
D
Saralaya
Inhalation Consultancy Ltd Tarn House (Formerly Division of Pharmacy, School of Applied Sciences, University of Huddersfield), 55 High Street, Yeadon, Leeds, UK. h.chrystyn@gmail.com.
Henry
H
Chrystyn
D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D000069502:Budesonide, Formoterol Fumarate Drug Combination / Q000008:administration & dosage*; D002648:Child; D018592:Cross-Over Studies; D058995:Dry Powder Inhalers; D004867:Equipment Design; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D001239:Inhalation; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D055815:Young Adult
D018927:Anti-Asthmatic Agents; D000069502:Budesonide, Formoterol Fumarate Drug Combination