Table 1.
Sociodemographic and clinical characteristics
| Characteristics | Overall sample day 1a (n=1,663) |
|---|---|
| Age, mean (SD) | 63.9 (8.9) |
| Sex female, n (%) | 778 (46.8) |
| Race/ethnicity, n (%) | |
| American Indian/Alaskan native | 7 (0.4) |
| Asian | 6 (0.4) |
| Black or African American | 95 (5.7) |
| Native Hawaiian/Pacific Islander | 2 (0.1) |
| White | 1,550 (93.2) |
| Other | 3 (0.2) |
| FEV1, mean (SD), L | 1.4 (0.5) |
| FEV1, % predicted, mean (SD)1 | 49.0 (14.0) |
| FVC, mean (SD), L | 2.77 (0.85) |
| SGRQ,b n | 1,648 |
| Total score, mean (SD) | 46.5 (18.5) |
| Symptoms domain score, mean (SD) | 65.1 (21.4) |
| Activity domain score, mean (SD) | 60.6 (22.3) |
| Impacts domain score, mean (SD) | 32.7 (19.4) |
| E-RS total,c mean (SD; n) | 9.6 (6.30; 1,658) |
| GOLD stage, n (%) | |
| I | 4 (0.2) |
| II | 946 (56.9) |
| III | 696 (41.9) |
| IV | 12 (0.7) |
Notes:
For patients who were missing the NiSCI diary entry on day 1 (day of randomization), data from the closest day before day 1 were used.
SGRQ scores range from 0 to 100; higher score=more severe health status.
The E-RS total score is an aggregate of three domains identified on the E-RS. Scores range from 0 to 40; higher score=more severe respiratory symptoms.
Abbreviations: SD, standard deviation; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; SGRQ, St George’s Respiratory Questionnaire; E-RS, Exacerbations of Chronic Obstructive Pulmonary Disease Tool-Respiratory Symptoms; GOLD, Global Initiative for Chronic Obstructive Lung Disease; NiSCI, Nighttime Symptoms of COPD Instrument.