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* Symbicort improves HRQL (SGRQ total score) SGRQ and SF 36 were used in both studies, but the data presented here are from the SGRQ, as recommended in the CPMP guidelines. The presentation is limited to the total scores, since this is the basis for assessment of clincial relevance, where a reduction of 4 is considered as a clinically relevant positive change.1 The change seen in the Symbicort group significantly exceeded the level which is clinically noticeable to the patient. Reference 1. PW Jones. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J 2002;19(3): 398-404. * The first patient was enrolled on November 8th 2012, and the last patient completed the study on February 28th 2014. After assessing the eligibility during a 14-day run in period, patients were randomized (1:1) to receive either IND/GLY 110/50 μg once daily delivered via the Breezhaler? device (Novartis Pharma AG, Stein, Switzerland) or SFC 50/500 μg twice daily delivered via the Accuhaler? device (Glaxo Operations UK, Ware, UK) and matching placebos. The patients were treated in the morning (08:00 and 11:00 hours from both the devices) and evening (approximately 12 hours after the morning dose, Accuhaler? device only). Reference Zhong N, Wang C, Zhou X, Zhang N, Humphries M, Wang L, Thach C, Patalano F, Banerji D. LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. International Journal of Chronic Obstructive Pulmonary Disease. 2015 (In press ) * n, number of patients; FEV1, forced expiratory volume in one second; SFC, salmeterol/fluticasone. At Week 26, IND/GLY was deemed to be non-inferior to SFC by meeting the pre-defined non-inferiority margin of -60 mL in trough FEV1 (treatment difference (Δ) = 72 mL, 95% CI: 40, 104) for the per protocol set. IND/GLY treatment demonstrated statistically significant superiority to SFC for trough FEV1 (Δ = 75 mL, 95% CI: 44, 107; P0.001)
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