Additional file 1 of Dose selection for glycopyrrolate/eFlow® phase III clinical studies: results from GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) phase II dose-finding studies

Online Supplementary Data. Table S1. Patient demographics and baseline characteristics, GOLDEN 2 (ITT population). Table S2. Patient demographics and baseline characteristics, GOLDEN 6 (safety population). Table S3. Change from baseline in trough FEV1 on Day 7 and Day 28, GOLDEN 2 (ITT population). Table S4. Change from baseline in trough FEV1 on Day 7, GOLDEN 6 (efficacy population). Table S5. Standardized change from baseline in FEV1AUC0–12 on Day 7 and Day 28, GOLDEN 2 (ITT population). Table S6. Standardized change from baseline in FEV1 AUC0–12 on Day 7, GOLDEN 6 (efficacy population). Table S7. Change from baseline in peak FEV1 on Day 28, GOLDEN 2 (ITT population). Figure S1. Least squares mean change from baseline in FEV1 over time on Day 28 (GOLDEN 2 Substudya ITT population). Figure S2. Mean change from baseline in FEV1 over time on Day 7 (GOLDEN 6 efficacy population). (DOCX 269 kb

Additional file 1: of A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease

Study design; Additional Fig. 1. Study design schematic; Additional Fig. 2. Mean change from baseline in PEFR over time by treatment on Day 7 (mITT population); Additional Fig. 3. Mean change from baseline FVC over time by treatment on Day 7 (mITT population); Additional Table 1. Secondary efficacy endpoints: Days 1 and 7 – FF 9.6 μg and FF 7.2 μg comparisons (mITT population). (DOCX 466 kb