Impending chronic obstructive pulmonary disease (COPD) exacerbations are heralded by 10 days of worsening COPD symptoms, worsening pulmonary function, and increased daytime rescue medication use, said Donald P. Tashkin, MD, Director, Pulmonary Function Lab - oratory, Uni versity of California at Los Angeles.
Dr Tashkin evaluated the changes in symptoms and pulmonary function during the 10 days preceding an initial COPD exacerbation in 1964 patients with moderate-to-verysevere COPD. To be eligible, patients could not have had an exacerbation within 1 month of their pre-enrollment screening. COPD exacerbations were defined as those requiring oral corticosteroids or hospitalization.
Patients were being treated with twice-daily budesonide/formoterol pressurized metered-dose inhaler (MDI) 320/9 μg, budesonide/formoterol pressurized MDI 160/9 μg, formoterol dry powder inhaler 9 μg, or placebo.
Patients recorded dyspnea, cough, and sputum scores; peak expiratory flow; and nighttime rescue medication use (inhalations/night) in a diary. Mean changes from baseline in those variables were assessed during the 10 days preceding the patient’s first exacerbation. A total of 669 had ≥1 exacerbations. Patients with exacerbations had more severe disease and worse lung function at baseline.
“There were slight increases in sputum, dyspnea, and cough starting 10 days prior to exacerbations,” Dr Tashkin said.
The mean change in dyspnea score overall during the 10 days was approximately 0.40 units, which exceeded the predefined criteria for a minimal important difference (0.2- unit difference).
No matter which treatment the patient received, the mean changes in scores indicating dyspnea, cough, and sputum accelerated at day 5 before the exacerbation.
“There was a small change in peak flow in the run off to exacerbation,” he said. “The trajectories were similar with all drugs.” Morning peak expiratory flow (all treatment groups combined) dropped by 9.4 L/min starting 10 days before the exacerbation.
An increase in the use of rescue medications occurred, especially in the 5 days closest to the exacerbation, with a similar pattern of increase across all treatment groups