Inhaled beclomethasone versus placebo for chronic asthma (Cochrane Review)

A substantive amendment to this systematic review was last made on 09 June 1999. Cochrane reviews are regularly checked and updated if necessary.

Background: Inhaled beclomethasone dipropionate (BDP) has been, together with inhaled budesonide, the mainstay of anti-inflammatory therapy for asthma for many years. A range of new prophylactic therapies for asthma is becoming available and BDP is now frequently used as the reference treatment against which these newer agents are being compared.

Objectives: The objectives of this review were to: (1) Compare the efficacy of BDP with placebo in the treatment of chronic asthma.(2) Explore the possibility that a dose response relationship exists for BDP in the treatment of chronic asthma.(3) To provide the best estimate of the efficacy of BDP as a benchmark for evaluation of newer asthma therapies.

Search strategy: We searched the Cochrane Airways Group Trial Register (1999) and reference lists of articles. We contacted trialists and Glaxo Wellcome for additional studies and searched abstracts of major respiratory society meetings (1997 to 1999).

Selection criteria: Randomised trials in children and adults comparing BDP to placebo in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.

Data collection and analysis: One reviewer extracted data; authors were contacted to clarify missing information. Quantitative analyses where undertaken using Review Manager (RevMan) 4.0.3 with MetaView 3.1.

Main results: 52 studies were selected for inclusion (3459 subjects). The studies were generally of high methodological quality. In non-oral steroid treated patients, BDP produced significant improvements in a number of efficacy measures compared to placebo including forced expiratory volume in one second (FEV1) weighted mean difference (WMD) 340 ml (95% CI 190 to 500 ml); FEV1 (% predicted) WMD 6% (95% CI 0.4 to 11.5%) and morning peak expiratory flow rate (PEFR) WMD 50 L/min (95% CI 8 to 92 L/min). BDP also led to reductions in rescue beta2 agonist use compared to placebo WMD 1.75 puffs/d (95% CI 1.4 to 2.4 puffs/d) and reduced the likelihood of trial withdrawal due to asthma exacerbation relative risk (RR) 0.26 (95% CI 0.15 to 0.43). In oral steroid treated patients BDP led to significantly greater reductions in oral prednisolone use WMD 5 mg/d (95% CI 4 to 6 mg/d) and a higher likelihood of discontinuing oral prednisolone RR 0.54 (95% CI 0.43 to 0.67). There was little evidence for a clinically worthwhile dose response effect, but few studies recruited patients with more severe asthma.

Reviewers' conclusions: This review has quantified the efficacy of BDP in the treatment of chronic asthma and strongly supports its use. Current asthma guidelines recommend titration of dose to individual patient response, but the published data provide little support for dose titration above 400 mcg/d in patients with mild to moderate asthma. There are insufficient data to draw any conclusions concerning dose-response in patients with severe disease.

Citation: Adams NP, Bestall JB, Jones PW. Inhaled beclomethasone versus placebo for chronic asthma (Cochrane Review). In: The Cochrane Library, Issue 3, 2003. Oxford: Update Software.

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This is an abstract of a regularly updated, systematic review prepared and maintained by the Cochrane Collaboration. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).

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