Asthma and lower airway disease
Randomized controlled trial of adherence with single or combination inhaled corticosteroid/long-acting β-agonist inhaler therapy in asthma

https://doi.org/10.1016/j.jaci.2010.06.033Get rights and content

Background

The inhaled corticosteroid (ICS)/long-acting β-agonist (LABA) combination inhaler has the potential to improve adherence with ICS therapy in asthma.

Objective

To determine whether ICS/LABA combination inhaler therapy improves adherence compared with separate inhaler use.

Methods

In a 24-week randomized controlled parallel group study, 111 subjects were prescribed 125 μg fluticasone dipropionate (FP) and 25 μg salmeterol, 2 actuations twice daily through either a combination inhaler or separate inhalers concurrently. Medication use was recorded by covert electronic monitors. The primary outcome variable was adherence during the final 6-week period, defined as the number of doses taken as a percentage of those prescribed.

Results

Complete adherence data from the final 6-week period were available for 49 and 54 subjects in the separate and combination groups, respectively. The mean (SD) adherence was 73.7% (36.0) for FP, 76.7% (30.5) for salmeterol, and 82.4% (24.5) for FP/salmeterol. There were no significant differences in adherence between FP/salmeterol and FP (–8.7%; 95% CI, –10.6 to 3.3) and salmeterol (–5.6%; 95% CI, –16.4 to 5.1). There was no significant difference in overuse among the FP, salmeterol, or FP/salmeterol groups. In 2 (4%) of 49 subjects, salmeterol was effectively taken as monotherapy during a 6-week period.

Conclusion

In the setting of a randomized controlled trial, use of a combination ICS/LABA inhaler does not markedly increase adherence above that observed with separate inhaler use. LABA monotherapy was observed in a small proportion of patients prescribed ICS and LABA therapy via separate inhalers.

Section snippets

Subjects

Adults in the Wellington region age 16 to 65 years with a diagnosis of asthma were enrolled (Fig 1). Subjects were recruited from existing research volunteer databases, newspaper advertisements, and letters via family doctors. To be included, subjects had to have a diagnosis of asthma and to be currently taking ICS at a stable dose with or without a separate LABA inhaler. Exclusion criteria were a diagnosis of chronic obstructive pulmonary disease, current use of a combination ICS/LABA inhaler,

Results

There were 111 subjects (50 male) enrolled in the study, 54 to the separate inhaler group and 57 in the combination inhaler group. The 2 groups were well matched with regard to age, sex, baseline lung function, and asthma control (Table I). After allowing for withdrawals, complete adherence data from the final 6-week study period were available for 49 and 54 subjects in the separate and combination groups, respectively (Fig 1). Eligible participants were recruited and studied between February

Discussion

This is the first randomized controlled trial in which the effect of a combination ICS/LABA inhaler on adherence with ICS therapy has been directly measured by covert electronic monitors. It has demonstrated that although the point estimates were consistent with greater adherence with FP/salmeterol, there was no significant difference compared with FP and salmeterol prescribed in separate inhalers. Furthermore, there was no evidence of a significant difference in preferential overuse of

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  • Cited by (0)

    Supported by a research grant from GlaxoSmithKline (GSK study no. SAM106689).

    The trial was registered with the Australian New Zealand Clinical Trials Registry, ACTRN12606000508572.

    In this article, the term adherence has been used rather than compliance because of the willing partnership between the clinician and patient in the setting of the research study.

    Disclosure of potential conflict of interest: R. Beasley has received a consulting fee and research support from GlaxoSmithKline. The rest of the authors have declared that they have no conflict of interest.

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