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Original Research: COPD |

A Pooled Analysis of FEV1 Decline in COPD Patients Randomized to Inhaled Corticosteroids or Placebo*

Joan B. Soriano, MD, PhD; Don D. Sin, MD, FCCP; Xuekui Zhang, MSc; Pat G. Camp, MSc; Julie A. Anderson, MD; Nick R. Anthonisen, MD; A. Sonia Buist, MD; P. Sherwood Burge, MD; Peter M. Calverley, MD; John E. Connett, PhD; Stefan Petersson, PhD; Dirkje S. Postma, MD; Wojciech Szafranski, MD; Jørgen Vestbo, MD
Author and Funding Information

*From the Program of Epidemiology and Clinical Research (Dr. Soriano), Fundació Caubet-CIMERA Illes Balears, International Centre for Advanced Respiratory Medicine, Bunyola, Mallorca, Illes Balears, Spain; James Hogg iCAPTURE Center for Cardiovascular and Pulmonary Research (Dr. Sin, Mr. Zhang, and Ms. Camp), St. Paul’s Hospital, Vancouver, BC, Canada; the Department of Statistics (Dr. Anderson), GlaxoSmihKline R&D, Greenford, Middlesex, UK; the Department of Medicine (Dr. Anthonisen), University of Manitoba, Winnipeg, MB, Canada; the Department of Medicine (Dr. Buist), Oregon Health and Science University, Portland, OR; the Department of Respiratory Medicine (Dr. Burge), Heartlands Hospital NHS Trust, Birmingham, UK; the Department of Medicine (Dr. Calverley), University Hospital Aintree, Liverpool, UK; the Division of Biostatistics (Dr. Connett), School of Public Health, University of Minnesota, Minneapolis, MN; the Department of Statistics (Dr. Petersson), AstraZeneca R&D, Lund, Sweden; the Department of Pulmonology (Dr. Postma), University of Groningen, the Netherlands; the Department of Lung Diseases (Dr. Szafranski), Voivodeship Specialist Hospital, Radom, Poland; and North West Lung Centre (Dr. Vestbo), South Manchester University Hospital NHS Trust, Wythenshawe Hospital, Manchester, UK.

Correspondence to: Joan B. Soriano, MD, PhD, Head, Program of Epidemiology and Clinical Research, Fundació Caubet-CIMERA Illes Balears, International Centre for Advanced Respiratory Medicine, Recinte Hospital Joan March, Carretera Soller Km 12; 07110 Bunyola, Mallorca, Spain; e-mail: jbsoriano@caubet-cimera.es



Chest. 2007;131(3):682-689. doi:10.1378/chest.06-1696
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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 FEV1 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 smoking 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 FEV1 among those who completed these randomized clinical trials.

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