The patients were randomized 1:1 into one of two treatment groups: high dose (HD) and medium dose (MD) ICS. The definition of an HD of ICS was fluticasone 1,000 μg/day, and the definition of an MD was fluticasone 500 μg/day. Both treatment groups received salmeterol 100 μg/day, administered via a hydrofluoroalkane pressurized metered-dose inhaler with a space device (GlaxoSmithKline, London, UK). Randomization was conducted centrally by means of a computer-generated random-number sequence.
Definition of an acute exacerbation of COPD was an acute event characterized by a worsening of the patient’s respiratory symptoms beyond normal day-to day variation leading to a change in medications.14 (link) Chest radiographs were performed and evaluated by the investigators (respiratory physicians) when an exacerbation of COPD was detected. Pneumonia was diagnosed if there was radiographic evidence of a pulmonary infection (new consolidation and/or infiltrates on the chest radiograph). Sputum Gram staining and bacteria cultures were performed. In addition, sputum acid-fast staining and tuberculosis cultures were also checked if tuberculosis infection was suspected clinically. If chest X-rays were not available, the patients were not enrolled into this study.
Definition of an acute exacerbation of COPD was an acute event characterized by a worsening of the patient’s respiratory symptoms beyond normal day-to day variation leading to a change in medications.14 (link) Chest radiographs were performed and evaluated by the investigators (respiratory physicians) when an exacerbation of COPD was detected. Pneumonia was diagnosed if there was radiographic evidence of a pulmonary infection (new consolidation and/or infiltrates on the chest radiograph). Sputum Gram staining and bacteria cultures were performed. In addition, sputum acid-fast staining and tuberculosis cultures were also checked if tuberculosis infection was suspected clinically. If chest X-rays were not available, the patients were not enrolled into this study.