Table S1. Excluded medications and time intervals prior to screening

Medication / Time interval
Depot corticosteroids / 12 weeks
Oral or parenteral corticosteroidsa / 6 weeks
Antibiotics (for lower respiratory tract infection)b / 6 weeks
Cytochrome P450 3A4 strong inhibitors / 6 weeks
ICS/LABA combination products (e.g., fluticasone/salmeterol, mometasonefuroate/formoterol fumarate, budesonide/formoterol fumarate) / 30 days (If ICS/LABA therapy was discontinued completely)
If discontinuing LABA therapy and switching to ICS monotherapyc / 48 hours for salmeterol or formoterol
14 days for olodaterol, indacaterol orvilanterol
Use of ICS at a dose >1000 mcg/day of fluticasone propionate or equivalentc / 30 days
Initiation or discontinuation of ICS usec / 30 days
Inhaled LABA
Formoterol, salmeterol / 48 hours
Indacaterol, olodaterol and vilanterol / 14 days
LAMA
Aclidinium, glycopyrronium, tiotropium, and umeclidinium / 7 days
LABA/LAMA combination products / Whichever mono-component had the longest washout
Roflumilast / 14 days
Oral beta-agonists
Long-acting / 48 hours
Short-acting / 12 hours
Theophyllines / 48 hours
Oral leukotriene inhibitors (montelukast, zafirlukast, zileuton) / 48 hours
Inhaled sodium cromoglycate or nedocromil sodium / 24 hours
Inhaled SABAsd / 4 hours
Inhaled SAMAs e / 4 hours
Inhaled SAMA/SABA combination products / 4 hours
Any other investigational medication / 30 days or within 5 drug half-lives (whichever is longer)

aLocalized corticosteroid injections (e.g., intra-articular and epidural) were permitted. Systemic corticosteroids were permitted during the study (post-randomization) for up to 14 days, for treatment of COPD exacerbations.

bAntibiotic use was permitted during the study (post-randomization).

cThe dose of ICS must not have exceeded 1000 mcg/day of fluticasone propionate or equivalent.

dUse of study-provided salbutamol was permitted during the study, except in the 4-hour period prior to morning spirometry testing.

eIpratropium bromide alone was permitted up to 4 hours prior to Visit 1 and during run-in, provided that the patient was on a stable dose prior to Screening (Visit 1). Following run-in, ipratropium bromide was discontinued 4 hours prior to Visit 2 and could not be re-taken until after the completion of the final clinic visit (Visit 8).

COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; SABA, short-acting β-agonist; SAMA, short-acting muscarinic antagonist.

Table S2. Patients in the ITT population, by country

Country / Patients in the
ITT population, n (%)
N=961
Germany / 158 (16)
Russian Federation / 158 (16)
Hungary / 108 (11)
Argentina / 96 (10)
Romania / 98 (10)
Poland / 77 (8)
Chile / 61 (6)
Peru / 57 (6)
Slovakia / 52 (5)
Estonia / 35 (4)
Italy / 32 (3)
France / 29 (3)

Figure S1.LS mean change from baseline (95% CI) in serial FEV1 (L) on Day 1 (a) and Day 84 (b) (ITT Population)

CI, confidence interval; FEV1, forced expiratory volume in one second; IND, indacaterol; ITT, intent-to-treat; LS, least squares; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.

FigureS2.LS mean change from baseline (95% CI) in serial FVC (L) on Day 1 (a) and Day 84 (b) (ITT population)

CI, confidence interval; FVC, forced vital capacity; IND, indacaterol; ITT, intent-to-treat; LS, least squares; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.