Chest
Original ResearchCopdReported Pneumonia in Patients With COPD: Findings From the INSPIRE Study
Section snippets
Materials and Methods
The study methodology and primary outcomes of the INSPIRE study have been published.17, 22 Patients were randomized to receive salmeterol plus fluticasone propionate 50/500 μg bid (SFC) or tiotropium bromide 18 μg once daily (Tio) in a 2-year, multicenter, double-blind, double-dummy parallel study.
Baseline measurements included age, sex, smoking status, FEV1 (before and after 400 μg salbutamol), health status using the St. George's Respiratory Questionnaire (SGRQ),23 modified Medical Research
Results
In the 1,930 patient-years of evaluable postrandomization data there were 2,255 HCU exacerbations (1,185 SFC; 1,070 Tio) and 5,152 symptom-defined events (2,720 SFC; 2,432 Tio). Pneumonia events were reported by 74 patients on 87 occasions (SFC: 50 patients, 62 events; Tio: 24 patients, 25 events (Fig 1, Table 1). The estimated on-treatment probability of having pneumonia by 2 years was 9.4% in the SFC arm and 4.9% in the Tio arm. The HR for time to first pneumonia was 1.94 (95% CI, 1.19-3.17)
Discussion
Our data provide important new insights into the relationships of respiratory symptoms used to define COPD exacerbations and the occurrence of physician-diagnosed pneumonia. We found that reported symptoms increased prior to pneumonia. Patients receiving the ICS/LABA combination were more likely to have had an unresolved exacerbation before a pneumonia diagnosis. Risk factors, including increased CRP levels, were associated with increased risk of pneumonia but did not explain the greater
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For editorial comment see page 483.
Funding/Support: This study was funded by GlaxoSmithKline.
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