Abstract
BackgroundDebate continues as to whether acute bronchodilator responsiveness (BDR) predicts long-term outcomes in COPD. Furthermore, there is no consensus on a threshold for BDR.MethodsAt baseline and during the 4-year Understanding Potential Long-term Improvements in Function with Tiotropium (UPLIFT®) trial, patients had spirometry performed before and after administration of ipratropium bromide 80 mcg and albuterol 400 mcg. Patients were split according to three BDR thresholds: ≥12% + ≥200 mL above baseline (criterion A), ≥15% above baseline (criterion B); and ≥10% absolute increase in percent predicted FEV1 values (criterion C). Several outcomes (pre-dose spirometry, exacerbations, St. George's Respiratory Questionnaire [SGRQ] total score) were assessed according to presence or absence of BDR in the treatment groups.Results5783 of 5993 randomized patients had evaluable pre- and post-bronchodilator spirometry at baseline. Mean age (SD) was 64 (8) years, with 75% men, mean post-bronchodilator FEV1 1.33 ± 0.44 L (47.6 ± 12.7% predicted) and 30% current smokers. At baseline, 52%, 66%, and 39% of patients had acute BDR using criterion A, B, and C, respectively. The presence of BDR was variable at follow-up visits. Statistically significant improvements in spirometry and health outcomes occurred with tiotropium regardless of the baseline BDR or criterion used.ConclusionsA large proportion of COPD patients demonstrate significant acute BDR. BDR in these patients is variable over time and differs according to the criterion used. BDR status at baseline does not predict long-term response to tiotropium. Assessment of acute BDR should not be used as a decision-making tool when prescribing tiotropium to patients with COPD.
Highlights
Debate continues as to whether acute bronchodilator responsiveness (BDR) predicts long-term outcomes in Chronic obstructive pulmonary disease (COPD)
Patients Patients were recruited from 490 investigational sites in 37 countries. They were eligible for inclusion if they had a diagnosis of COPD, were aged ≥40 years with a smoking history of at least 10 pack-years, had post-bronchodilator FEV1 ≤70% of predicted, and FEV1 to forced vital capacity (FVC) ratio of
Patients’ demographics and baseline characteristics were similar when classified according to BDR criteria A, B, and C except for baseline St. George’s Respiratory Questionnaire (SGRQ) total score, which indicated worse healthrelated quality of life for nonresponders for patients meeting criteria A and C (Table 1)
Summary
Debate continues as to whether acute bronchodilator responsiveness (BDR) predicts long-term outcomes in COPD. A 1-year trial with tiotropium showed that acute responsiveness was not predictive of whether patients improved clinically [4]. Whether such responsiveness can predict disease progression or health outcomes beyond 1 year has not been established. The Understanding Potential Long-term Improvements in Function with Tiotropium (UPLIFT®) trial was a 4-year placebo-controlled clinical trial evaluating the long-term effects of tiotropium 18 mcg daily on lung function, exacerbations, health-related quality of life and mortality in a large group of patients with COPD [9,10]. We further evaluate the acute bronchodilator response over the four years of the trial
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