Tiotropium/Olodaterol Combination vs Tiotropium Alone for Severe COPD Exacerbations
A total of 7880 patients with COPD and ≥1 moderate to severe exacerbation in the past 12 months were enrolled in this double-blind clinical trial.
This article is part of Pulmonology Advisor's coverage of the American Thoracic Society's International Conference, taking place in San Diego, California. Our staff will report on medical research related to asthma and other respiratory conditions, conducted by experts in the field. Check back regularly for more news from ATS 2018.
SAN DIEGO — Tiotropium may be more effective in reducing the rate of moderate and severe chronic obstructive pulmonary disorder (COPD)-related exacerbations when used in combination with olodaterol vs tiotropium alone, according to the results of a clinical trial presented at the American Thoracic Society (ATS) 2018 International Conference, held May 18-23, in San Diego, California.
A total of 7880 patients with COPD and ≥1 moderate to severe exacerbation in the past 12 months were enrolled in this double-blind clinical trial (DYNAGITO; ClinicalTrials.gov identifier: NCT02296138), and were randomly assigned to receive a tiotropium/olodaterol combination (5 μg each), or tiotropium alone (5 μg, delivered with Respimat®) once a day for 52 weeks. The rate of moderate (ie, <2 increase/new symptoms requiring antibiotics and/or corticosteroids) or severe (ie, symptoms requiring hospitalization or emergency room visit) COPD-related exacerbations during the trial was the primary outcome.
At baseline, 39.7% of study participants were taking a combination of long-acting muscarinic antagonists (LAMAs), long-acting β2-agonists (LABAs), and inhaled corticosteroids (ICS); 25.8% were treated with a combination of LABAs and ICS; and 11.9% were treated with a combination of LAMAs and LABAs. Participants were allowed to continue taking ICS throughout the study period. At baseline, participants had a predicted forced expiratory volume 1 second (FEV1) <60% and after bronchodilator treatment, the mean FEV1 was 44.5%.
A higher percentage of study participants taking tiotropium alone vs the tiotropium/olodaterol combination discontinued the trial (16.5% vs 12.4%, respectively). The rate of moderate or severe exacerbations was reduced by 7% in patients taking the tiotropium/olodaterol combination vs tiotropium alone (rate ratio [RR], 0.93; 99% CI, 0.85-1.02; P =.0498), but this effect did not achieve the level of significance set at .01 to “establish a higher degree of evidence within a single trial.”
The reduced rate of severe exacerbations (RR, 0.89; 95% CI, 0.78-1.02; P =.0903) and of exacerbations treated with corticosteroids alone or in combination with antibiotics were mainly responsible for the beneficial effect of the tiotropium/olodaterol combination vs tiotropium alone.
“Larger, potentially significant effects were seen in severe exacerbations and those treated with corticosteroids, with or without antibiotics,” concluded the study investigators. “There was a lower rate of discontinuation with [tiotropium/olodaterol] compared with [tiotropium] which may have affected the results.”
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Calverley PM, Carter K, Grönke L, et al. Tiotropium/olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations: Results from the DYNAGITO trial. Presented at: American Thoracic Society 2018 International Conference; May 18-23, 2018; San Diego, CA. Abstract 7410.