Effects of Symptom Severity at Baseline on Lung-Funktion and SGRQ Responses in the OTEMTO Studies
23 February 2017 (online)
This post hoc analysis of the OTEMTO® 1 and 2 studies (NC01431274;NCT01431287) investigated whether symptomatic status at inclusion, as measured by the modified Medical Research Council (mMRC) dyspnea scale and the Baseline Dyspnea Index (BDI), influenced lung-function and SGRQ responses.
Patients aged ≥40 years with moderate to severe COPD received t+o 2.5/5 mcg, t+o 5/5 mcg, t 5 mcg, or placebo (p) q.d. for 12 weeks via Respimat®. SGRQ total score and lung function (FEV1 area under the curve from 0 – 3 hours [AUC0 – 3] and trough FEV1 responses) were primary end points. Patients completed the mMRC and BDI scales at baseline. We report comparisons between t+o 5/5 mcg, t 5 mcg, and p after 12 weeks by mMRC and BDI status at baseline.
1621 patients were evaluated: 736 patients (45%) had mMRC scores < 2, 883 patients (54%) >/= 2 (scored from grade 0 – 5, lower is better); 418 patients (26%) had BDI scores < 6, 1201 patients (74%) ≥6 (scored from 0 – 12, higher is better). Improvements in FEV1 AUC0 – 3 and trough FEV1 were observed with t+o compared to t and p in patients with mMRC score < 2 (0.107 and 0.303 l; 0.046 and 0.164 l, respectively) and ≥2 (0.109 and 0.321 l; 0.022 and 0.163 l), as well as in patients with BDI score ≥6 (0.110 and 0.323 l; 0.040 and 0.178 l, respectively) and < 6 (0.098 and 0.283 l; 0.012 and 0.120 l). All BDI and mMRC groups demonstrated improvements in SGRQ with t+o compared to p above the minimal clinically important difference.
There was a trend towards better lung-function improvement with t+o versus t or p in less symptomatic patients assessed by baseline BDI. More severe dyspnea by mMRC category was associated with improved SGRQ with t+o vs. t or p, but did not affect lung-function improvement. Overall, t+o provides lung-function and quality of life benefits regardless of symptomatic status prior to treatment.
Content already presented at ATS congress 2016