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Spiromax delivers accurate doses throughout its lifetime

Spiromax inhalers demonstrated delivery of consistent, accurate doses throughout the inhaler’s life after exposures to common every day elements, according to study results.

The doses appeared to remain consistent after researchers exposed the inhalers to variations in temperature, humidity, inspiratory flow rate, orientation during inhalation as well as possible damage.

Giorgio W. Canonica, MD, of the department of internal medicine at University of Genoa, and colleagues conducted dose-delivery studies with the use of low- (n = 41), middle- (n = 42) and high-strength (n = 42) DuoResp Spiromax (budesonide/formoterol fumarate dihydrate, Teva) inhalers to analyze dose consistency over the life of the inhaler.

The researchers performed controlled laboratory tests to determine total emitted doses after the researchers put the inhalers through exercises to mimic what a device would encounter when with a patient.

Researchers subjected inhalers to three temperature cycles to mimic conditions during transport from factory to dispenser, as well as exposure to low and high humidity. The researchers also dropped the differing doses of inhalers 90 to 110 cm onto a hard surface to monitor any changes in the devices accurate delivery of the right dose over time.

Total emitted dose appeared unaffected by high or low humidity (P > .05) — as well as temperature — and no dose build-up over the life of the inhaler occurred.

Except for one inhaler with a broken mouthpiece after the researchers dropped it, all inhalers remained functional after the experiment. No powder leaked, dose counters did not change and internal components of the inhaler did not appear to have experienced any damage.

Children with asthma (n = 23), adolescents with asthma (n = 27), adults with asthma (n = 50), adults with COPD (n = 50) and healthy controls (n = 50) demonstrated a peak inspiratory flow rate or more than 30 L/min following training on how to use the device. Ninety percent of patients within the asthma groups demonstrated peak inspiratory flow rates higher than 58 L/min after enhanced training with the Spiromax device.

The inspiratory flow rate increased to 44 L/min after enhanced training with the device in 90% of patients with COPD.

There are limitations to the study, according to the researchers.

“For the in vitro studies, the main limitation is the performance of studies under laboratory conditions,” the researchers wrote. “Although these studies were designed to evaluate the impact of normal patient behaviors on the delivered dose of DuoResp via Spiromax, the studies cannot mimic all conceivable real-life scenarios. This is particularly the case if more than one scenario occurs simultaneously.” – by Ryan McDonald

Disclosure: Canonica reports receiving financial support from A. Menarini, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, GlaxoSmithKline, Lab. Guidotti, Malesci, Mundifarma, Novartis, Teva and Valeas. Please see the full study for a list of all other researchers’ relevant financial disclosures.