Retrospective characterization of airway reversibility in patients with asthma responsive to bronchodilators

ABSTRACT

Background: National and international asthma guidelines recommend the use of reversibility to assist in the diagnosis of asthma.

Scope: This retrospective pooled analysis assessed the reversibility characteristics of a large cohort of patients (n = 30 816) selected from 106 clinical trials conducted by GlaxoSmithKline in which bronchodilator reversibility (≥ 12%) was required for participation in the trials.

Findings: Patients (n = 1434) with a baseline forced expiratory volume in 1 second (FEV1) between 40% and < 50% at screening had a mean reversibility of 42% and those (n = 550) with a baseline FEV1 between 90% and < 100% had a mean reversibility of 18%. In general, the lower the patient's baseline lung function, the higher the reversibility. Further, in a subset of studies (n = 7; 1477 patients) that provided reversibility data at study baseline and endpoint, the mean reversibility for patients receiving placebo or fluticasone propionate (FP) was 26%. At study completion, nearly 30% fewer patients receiving placebo were shown to be reversible and approximately half of the patients receiving fluticasone propionate were no longer reversible.

Conclusion: This analysis shows that airway reversibility is affected by asthma severity as measured cross-sectionally by spirometry, pharmacotherapeutic interventions, including placebo, and time. Additional studies are needed to confirm this finding in broader populations as studies in this analysis were limited to those conducted in the US by GlaxoSmithKline.

Key words: :

• Asthma
• Bronchodilators
• Retrospective analysis
• Reversibility