Combination of formoterol and budesonide as single inhaler therapy versus inhaled corticosteroid maintenance and a separate reliever inhaler, or current best practice

Cates CJ, Lasserson TJ

Published Online:

January 20, 2010

A single combination inhaler containing formoterol and budesonide has been advocated for regular maintenance of asthma, with the option to increase the dose if the asthma flares up. This is sometimes known as single inhaler therapy. Single inhaler therapy can reduce the risk of asthma exacerbations needing oral corticosteroids in comparison with fixed dose maintenance inhaled corticosteroids. The trials were in people with asthma who had their maintenance treatment reduced and became symptomatic. These results have not yet been replicated in trials comparing single inhaler therapy with current best practice, and the results of five large trials are awaiting publication. The place of this new approach to asthma management must remain somewhat uncertain until all the trials are fully reported.

Abstract (click to read)

Background:

Traditionally inhaled treatment for asthma has been considered as preventer and reliever therapy. The combination of formoterol and budesonide in a single inhaler introduces the possibility of using a single inhaler for both prevention and relief of symptoms (single inhaler therapy).

Objectives:

The aim of this review is to compare formoterol and corticosteroid in single inhaler for maintenance and relief of symptoms with inhaled corticosteroids for maintenance and a separate reliever inhaler.

Search strategy:

We last searched the Cochrane Airways Group trials register in September 2008.

Selection criteria:

Randomised controlled trials in adults and children with chronic asthma.

Data collection and analysis:

Two review authors independently assessed studies for inclusion and extracted the characteristics and results of each study. Authors or manufacturers were asked to supply unpublished data in relation to primary outcomes.

Main results:

Five studies on 5,378 adults compared single inhaler therapy with current best practice, and did not show a significant reduction in participants with exacerbations causing hospitalisation (Peto OR 0.59; 95% CI 0.24 to 1.45) or treated with oral steroids (OR 0.83; 95% CI 0.66 to 1.03). Three of these studies on 4281 adults did not show a significant reduction in time to first severe exacerbation needing medical intervention (HR 0.96; 95% CI 0.85 to 1.07). These trials demonstrated a reduction in the mean total daily dose of inhaled corticosteroids with single inhaler therapy (mean reduction ranged from 107 to 267 micrograms/day, but the trial results were not combined due to heterogeneity). The full results from four further studies on 4,600 adults comparing single inhaler therapy with current best practice are awaited.

Three studies including 4,209 adults compared single inhaler therapy with higher dose budesonide maintenance and terbutaline for symptom relief. No significant reduction was found with single inhaler therapy in the risk of patients suffering an asthma exacerbation leading to hospitalisation (Peto OR 0.56; 95% CI 0.28 to 1.09), but fewer patients on single inhaler therapy needed a course of oral corticosteroids (OR 0.54; 95% CI 0.45 to 0.64). These results translate into an eleven month number needed to treat of 14 (95% CI 12 to 18), to prevent one patient being treated with oral corticosteroids for an exacerbation. The run-in for these studies involved withdrawal of long-acting beta2-agonists, and patients were recruited who were symptomatic during run-in.

One study included children (N = 224), in which single inhaler therapy was compared to higher dose budesonide. There was a significant reduction in participants who needed an increase in their inhaled steroids with single inhaler therapy, but there were only two hospitalisations for asthma and no separate data on courses of oral corticosteroids. Less inhaled and oral corticosteroids were used in the single inhaler therapy group and the annual height gain was also 1 cm greater in the single inhaler therapy group, [95% CI 0.3 to 1.7 cm].

There was no significant difference found in fatal or non-fatal serious adverse events for any of the comparisons.

Authors' conclusions:

Single inhaler therapy can reduce the risk of asthma exacerbations needing oral corticosteroids in comparison with fixed dose maintenance inhaled corticosteroids. Guidelines and common best practice suggest the addition of regular long-acting beta2-agonist to inhaled corticosteroids for uncontrolled asthma, and single inhaler therapy has not been demonstrated to significantly reduce exacerbations in comparison with current best practice, although results of five large trials are awaiting full publication. Single inhaler therapy is not currently licensed for children under 18 years of age in the United Kingdom.

This record should be cited as:

Cates CJ, Lasserson TJ. Combination formoterol and budesonide as maintenance and reliever therapy versus inhaled steroid maintenance for chronic asthma in adults and children. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD007313. DOI: 10.1002/14651858.CD007313.pub2

Assessed as up to date:

February 10, 2009

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Primary Review Group:

Airways Group

Asthma topics:

Treating with Medications > Combination Inhalers

Treating with Medications > Chronic Asthma > Combination and additive therapies

Health topics:

Lungs & airways > Asthma (chronic) > Combination/additive drug treatment

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

Combination of formoterol and budesonide as single inhaler therapy versus inhaled corticosteroid maintenance and a separate reliever inhaler, or current best practice

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