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Table 1 Demographics and clinical characteristics in Phase 1 and Phase 2

From: Measuring respiratory symptoms in moderate/severe asthma: evaluation of a respiratory symptom tool, the E-RS®: COPD in asthma populations

Phase 1

Demographicsa

Total (N = 25)

Age (years), mean (SD)

48 (16.5)

Female, n (%)

15 (60.0)

Racial backgroundb, n (%)

 White

21 (84.0)

 Black or African American

3 (12.0)

 Asian

1 (4.0)

 American Indian or Alaska Native

2 (8.0)

 Other

2 (8.0)

Employment statusb, n (%)

 Employed full-time

18 (72.0)

 Employed part-time

2 (8.0)

 Retired

3 (12.0)

 Student

1 (4.0)

 Other

2 (8.0)

Clinical characteristicsc

Time since diagnosis (years), mean (SD)

10.8 (11.8)

Asthma severity, n (%)

 Moderate

18 (72.0)

 Severe

7 (28.0)

Asthma control status, n (%)

 Controlled (ACQ score < 1.5 at screening)

16 (64.0)

 Uncontrolled (ACQ score ≥ 1.5 at screening)

9 (36.0)

FEV1 (L), mean (SD)

2.2 (0.8)

FEV1% predicted, mean (SD)

62.1 (11.5)

FEV1/FVC, mean (SD)

0.7 (0.1)

Number of patients experiencing exacerbations in the past 12 months, n (%)

12 (48.0)

Number of exacerbations in the last 12 months, mean (SD)

1.1 (1.6)

Phase 2

Characteristics

205715 (N = 2270)d, e

205832 (N = 420)e

Age, years, mean (SD)

53.3 (13.12)

48.8 (14.65)

Females, n (%)

1403 (61.8)

297 (70.7)

Hispanic or Latino ethnicity, n (%)

235 (10.4)

9 (2.1)

Race, n (%)

 White

1888 (83.2)

386 (91.9)

 Asian

279 (12.3)

6 (1.4)

 Black

84 (3.7)

26 (6.2)

 Other

17 (0.7)

2 (0.5)

 Missing

2 (0.1)

0 (0.0)

FEV1 (L)f, mean (SD)

2.0 (0.74)

2.2 (0.67)

FEV1% predictedf, mean (SD)

70.7 (14.29)

70.9 (11.13)

Exacerbations in last 12 months, mean (SD)

1.4 (1.29)

0.3 (0.72)

Smoking history, n (%)

 Never

1835 (80.8)

388 (92.4)

 Former

430 (18.9)

32 (7.6)

 Missing

5 (0.2)

0 (0.0)

E-RS: COPD Total Score, mean (SD)

8.3 (6.30)

7.2 (5.66)

ACQ-5, mean (SD)

2.0 (0.77)

1.8 (0.61)

  1. ACQ Asthma Control Questionnaire, FEV1 Forced expiratory volume in 1 s, FVC Forced vital capacity, ITT Intent-to-treat, SD Standard deviation
  2. aFrom self-reported quantitative patient data; bnot mutually exclusive; cfrom site-reported quantitative data; dinterim blinded data only; e2 ITT participants (205715) and 1 ITT participant (205832) with only 1 day or no pre-baseline data were excluded; fbased on pre-bronchodilator spirometry