Severe Dyspnea Influences COPD Treatment Response, Confirms Benefit of Combination Therapy

When to begin maintenance therapy for patients with chronic obstructive pulmonary disease (COPD) with either a single drug, or a combination of long-acting bronchodilators, is not always clear. A new study looking at whether baseline symptomatic status influences response to treatment suggests that patients with more severe dyspnea benefit more from a combination of tiotropium/olodaterol than tiotropium alone.

Researchers looked at data from 2 OTEMPO studies, which were double-blind, parallel-group, randomized controlled trials. Patients received 1 of 4 treatments for 12 weeks: tiotropium/olodaterol 2.5/5 mcg, tiotropium/olodaterol 5/5 mcg, tiotropium 5 mcg, or placebo, all given once daily using a Respimat inhaler.

Patients were 40 years or older and had moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. Patients were excluded from the study if they had a history of asthma, COPD exacerbation, or symptoms of a lower respiratory tract infection within the past 3 months.

In the 2 studies, 1621 patients were treated and 1619 had data available for analysis. Assessments were made using the Modified Medical Research Council (mMRC) dyspnea scale or the COPD Assessment Test to distinguish between patients with low or high symptoms. Researchers also sought to understand the relationship between baseline symptom severity and baseline lung function in predicting St George’s Respiratory Questionnaire (SGRQ) response.

Tiotropium/olodaterol improved SGRQ total scores and response rates compared with placebo and tiotropium for patients with baseline mMRC scores of 0 to 1 and 2 or greater. For tiotropium/olodaterol vs tiotropium, greater improvements were seen for patients with mMRC of 2 or greater (SGRQ score adjusted mean treatment difference, —3.44; 95% CI, –5.43 to –1.46; P = .0007; SGRQ response rate OR, 2.09; 95% CI, 1.41-3.10; P = .0002).

Dyspnea, as measured by transition dyspnea index score, improved with tiotropium/olodaterol versus placebo for patients with mMRC scores of 0 to 1 and 2 or greater (adjusted mean treatment differences, 1.63; 95% CI, 1.06-2.20; P <.0001; and 1.60; 95% CI, 1.09-2.10; P <.0001, respectively). In patients with mMRC scores of 0 to 1 and 2 or greater, tiotropium/olodaterol consistently improved transition dyspnea index response rate and lung function versus placebo and tiotropium.

The authors said the analysis confirmed that patients with COPD with more severe dyspnea at baseline, measured using the mMRC scale, had a greater response to tiotropium/olodaterol relative to tiotropium alone in both SGRQ total score and SGRQ responder rate.

Reference

Martinez FJ, Abrahams RA, Ferguson GT, et al. Effects of baseline symptom burden on treatment response in COPD [published online January 4, 2019]. Int J Chron Obstruct Pulmon Dis. doi: 10.2147/COPD.S179912.