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. 2017 Mar 21;4(2):132-140.
doi: 10.15326/jcopdf.4.2.2017.0129.

Baseline Severity as Predictor of Change in St George's Respiratory Questionnaire Scores in Trials of Long-acting Bronchodilators with COPD Patients

Paul W Jones  1   2 , Heather Gelhorn  3 , Niklas Karlsson  4 , Shailendra Menjoge  5 , Hana Müllerova  2 , Stephen I Rennard  6   7 , Ruth Tal-Singer  8 , Hilary Wilson  3 , Debora Merrill  9 , Maggie Tabberer  2
Affiliations

Baseline Severity as Predictor of Change in St George's Respiratory Questionnaire Scores in Trials of Long-acting Bronchodilators with COPD Patients

Paul W Jones et al. Chronic Obstr Pulm Dis. .

Abstract

Background: In trials oflong-acting bronchodilators, health status is an important trial outcome, however the influence of baseline severity on response measured by St George's Respiratory Questionnaire (SGRQ) is not known. We have compared SGRQ changes between patients with chronic obstructive pulmonary disease (COPD) of mild-moderate severity or dyspnea (Global initiative for chronic Obstructive Lung disease [GOLD] grades 1 and 2; modified Medical Research Council [mMRC] grades 1 and 2) to those with severe-very severe severity or dyspnea (GOLD grades 3 and 4; mMRC grades 3 and 4). Methods: Combined individual patient data from the COPD Biomarkers Qualification Consortium database (trials of long-acting bronchodilators) were used comprising of patients from short-term (≤1-year duration; n=10802) and medium-term (2-4 years' duration; n=8963) studies. A repeated measures analysis of variance (ANOVA) was used to determine the effects of baseline severity (GOLD/mMRC) on SGRQ response to treatment. All treatment arms were combined. Results: In short-term studies, milder patients showed a greater response than those with more severe disease in terms of GOLD grade (partial Eta2 = 0.03, p < 0.0001) and mMRC grade (partial Eta2 = 0.05, p < 0.0001). Similar results were seen in the medium-term studies (partial Eta2 = 0.02, p < 0.0001; mMRC: partial Eta2 = 0.05, p < 0.0001,). Conclusions: Patients with less severe airflow limitation and less severe dyspnea showed larger improvements in SGRQ score than more severely obstructed or dyspneic patients. Although these severity influences are small (2%-5% of the variance in SGRQ score), they do suggest that pre-specified separate analyses are warranted to test for differences in response, based on baseline severity.

Keywords: FEV1; CBQC; COPD Biomarkers Qualification Consortium; SGRQ; St George’s Respiratory Questionnaire; forced expiratory volume in 1 second; mMRC; modified Medical Research Council dyspnea scale; predictors.

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Conflict of interest statement

PWJ, NK, SM, HM, SIR, RTS and MT are employees and shareholders of the pharmaceutical companies who funded this analysis. HG and HW participated in this project as employees of Evidera, a company which performs work for hire for multiple pharmaceutical and device companies in outcomes research. DM has nothing to declare.

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