Chest
Volume 139, Issue 3, March 2011, Pages 505-512
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Original Research
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Reported Pneumonia in Patients With COPD: Findings From the INSPIRE Study

https://doi.org/10.1378/chest.09-2992Get rights and content

Background

Pneumonia is an important complication of COPD and is reported more often in patients receiving inhaled corticosteroids (ICSs). Little is known about the clinical course and factors predisposing to pneumonia in patients with COPD. We investigated patient characteristics and symptoms occurring before pneumonia reports in the Investigating New Standards for Prophylaxis in Reduction of Exacerbations (INSPIRE) study.

Methods

This was a 2-year, double-blind, double-dummy parallel study of 1,323 patients randomized to salmeterol/fluticasone propionate 50/500 μg bid (SFC) or tiotropium 18 μg once daily (Tio). Baseline demographics, including serum C-reactive protein (CRP) levels, were measured, and daily record cards (DRCs) were completed.

Results

We identified 87 pneumonia reports from adverse event records (SFC = 62; Tio = 25) in 74 patients (SFC = 50; Tio = 24), compared with 2,255 exacerbations (SFC = 1,185; Tio = 1,070). Pneumonia was more common in patients with severe dyspnea and in those with a baseline CRP level > 10 mg/L. Numbers of de novo pneumonias (events that were not preceded by symptoms of an exacerbation) were similar between treatment groups, but pneumonia was more likely after either a treated or untreated unresolved exacerbation in patients receiving ICSs (SFC = 32; Tio = 7). Similar results were seen when analysis was confined to radiologically confirmed events.

Conclusions

Pneumonia is much less frequent than exacerbation in COPD. The excess of events with ICS treatment appears to be associated with protracted symptomatic exacerbations. Earlier identification and treatment of these events to prevent pneumonia merits further investigation.

Trial registry

ClinicalTrials.gov; No.: NCT00361959; Study No.: SC040036; URL: clinicaltrials.gov

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.

    Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).

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