Table 1.
Baseline patient demographics and clinical characteristics of the intent-to-treat (ITT) population
| ITT population (N = 236) | |
|---|---|
| Age (years)a | 64.4 (8.5) |
| Male | 142 (60%) |
| Smoking status | |
| Never | 1 (< 1%) |
| Current | 125 (53%) |
| Former | 110 (47%) |
| Smoking pack-yearsa | 50.2 (25.52) |
| Postbronchodilator FEV1 (L)a | 1.734 (0.406) |
| Postbronchodilator percentage of predicted FEV1 a | 59.6 (5.6) |
| Reversible to albuterol therapyb | 86 (36%) |
| Exacerbation history in the 12 months before screening | |
| Treated without OCS and/or antibiotics | 7 (3%) |
| ≥ 1 requiring OCS/antibiotics | 33 (14%) |
| 2 requiring OCS/antibiotics | 4 (2%) |
| Requiring hospitalization | 6 (3%) |
| GOLD stage | |
| B | 224 (95%) |
| D | 12 (5%) |
| Modified Medical Research Council Dyspnoea Scale score | |
| 2 | 156 (66%) |
| 3 | 71 (30%) |
| 4 | 9 (4%) |
| Concomitant medical conditions (≥ 10% of patients) | |
| Hypertension | 134 (57%) |
| Hypercholesterolemia | 114 (48%) |
| Cardiac disorders | 58 (25%) |
| Coronary artery disease | 43 (18%) |
| Arrhythmia | 13 (6%) |
| Congestive heart failure | 6 (3%) |
| Myocardial infarction | 0 (0%) |
| Diabetes | 48 (20%) |
| IN populationc | 75 (32%) |
| Respiratory medications before run-in | |
| SABAd | 151 (64%) |
| LAMA | 38 (16%) |
| LABA | 29 (12%) |
| SAMA | 25 (11%) |
| ICS | 10 (4%) |
| LAMA/LABAe | 30 (13%) |
FEV 1 forced expiratory volume in 1 s, GOLD Global Initiative for Chronic Obstructive Lung Disease, ICS inhaled corticosteroid, IN inhaler naïve, LABA long-acting β2-agonist, LAMA long-acting muscarinic antagonist, OCS oral corticosteroids, SABA short-acting β2-agonist, SAMA short-acting muscarinic antagonist
aThe standard deviation is given in parentheses.
bReversibility defined as an increase in FEV1 of 12% or more and 200 mL or more following administration of bronchodilator
cDefined as all patients randomized to treatment who did not have a history of using either the ELLIPTA or the Respimat inhaler device
dContinued use of rescue albuterol therapy was permitted during the study, but other maintenance medications were excluded.
eGlycopyrronium/indacaterol (13, 6%), umeclidinium/vilanterol (10, 4%), tiotropium/olodaterol (6, 3%), and aclidinium/formoterol (1, less than 1%)