Background: There is controversy about whether therapy with inhaled corticosteroids (ICSs) modifies the natural history of COPD, characterized by an accelerated decline in FEV1. Methods: The Inhaled Steroids Effect Evaluation in COPD (ISEEC) study is a pooled study of patient-level data from seven long-term randomized controlled trials of ICS vs placebo lasting ≥ 12 months in patients with moderate-to-severe COPD. We have previously reported a survival benefit for ICS therapy in COPD patients using ISEEC data. We aimed to determine whether the regular use of ICSs vs placebo improves FEV1 decline in COPD patients, and whether this relationship is modified by gender and smoking. Results: There were 3,911 randomized participants (29.2% female) in this analysis. In the first 6 months after randomization, ICS use was associated with a significant mean (± SE) relative increase in FEV 1 of 2.42 ± 0.19% compared with placebo (p < 0.01), which is quantifiable in absolute terms as 42 mL in men and 29 mL in women over 6 months. From 6 to 36 months, there was no significant difference between placebo and ICS therapy in terms of FEV1 decline (-0.01 ± 0.09%; p = 0.86). The initial treatment effect was dependent on smoMng status and gender. Smokers who continued to smoke had a smaller increase in FEV1 during the first 6 months than did ex-smokers. Female ex-smokers had a larger increase in FEV1 with ICS therapy than did male ex-smokers. Conclusions: We conclude that in COPD in the first 6 months of treatment, ICS therapy is more effective in ex-smokers than in current smokers with COPD in improving lung function, and women may have a bigger response to ICSs than men. However, it seems that after 6 months, ICS therapy does not modify the decline in FEV 1 among those who completed these randomized clinical trials.
Bibliographical noteFunding Information:
Dr. Soriano was an employee of GlaxoSmithKline, a manufacturer of respiratory drugs, up to 2005. Dr. Sin has received honoraria for speaking engagements from AstraZeneca and GlaxoSmithKline, and has received consultancy fees and research funding from GlaxoSmithKline. Dr. Anderson is currently an employee of GlaxoSmithKline, a manufacturer of respiratory drugs. Dr. Anthonisen and Dr. Buist are members of a respiratory advisory board for GlaxoSmithKline. Dr. Calverley has received honoraria for speaking engagements and research funding from AstraZeneca and GlaxoSmithKline. Dr. Petersson is currently an employee of AstraZeneca, a manufacturer of respiratory drugs. Dr. Postma has received honoraria for speaking engagements and research funding from AstraZeneca and GlaxoSmithKline. Dr. Vestbo has received honoraria for speaking engagements and research funding from AstraZeneca and GlaxoSmithKline. Drs. Zhang, Camp, Burge, Connett, and Szafranski have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.
Interdisciplinary Capacity Enhancement: Bridging Excellence in Respiratory Disease and Gender Studies (ICEBERGS), which is supported by funding from Canadian Institutes of Health Research (IGH/ICRH), the Canadian Lung Association, and the Heart and Stroke Foundation of Canada ( http://www.icebergs.ubc.ca ).
- Natural history
- Pooled analysis