Table 1. Characteristics of the Participants at Baseline.*.
| Variable | Inhaled Fluticasone Furoate (N=656) |
Placebo (N=621) |
Total (N=1277) |
|---|---|---|---|
| Median age (IQR) — yr | 45 (37–55) | 46 (38–56) | 45 (37–55) |
| Age <50 yr — no. (%) | 405 (61.7) | 370 (59.6) | 775 (60.7) |
| Female sex — no. (%)† | 431 (65.7) | 376 (60.5) | 807 (63.2) |
| Race — no. (%)‡ | |||
| Black or African American | 47 (7.2) | 44 (7.1) | 91 (7.1) |
| White | 523 (79.7) | 500 (80.5) | 1023 (80.1) |
| Hispanic or Latino ethnic group — no./total no. (%)§ | 78/655 (11.9) | 83/620 (13.4) | 161/1275 (12.6) |
| United States region — no. (%) | |||
| Midwest | 141 (21.5) | 115 (18.5) | 256 (20.0) |
| Northeast | 52 (7.9) | 56 (9.0) | 108 (8.5) |
| South | 368 (56.1) | 371 (59.7) | 739 (57.9) |
| West | 95 (14.5) | 79 (12.7) | 174 (13.6) |
| Call center¶ | 96 (14.6) | 97 (15.6) | 193 (15.1) |
| Body-mass index‖ | |||
| Median (IQR) | 28.1 (24.4–33.6) | 28.1 (24.6–32.9) | 28.1 (24.4–33.4) |
| >30 — no./total no. (%) | 260/656 (39.6) | 239/620 (38.5) | 499/1276 (39.1) |
| Heart disease — no./total no. (%) | 25/640 (3.9) | 33/606 (5.4) | 58/1246 (4.7) |
| Diabetes — no./total no. (%) | 56/640 (8.8) | 65/606 (10.7) | 121/1246 (9.7) |
| Hypertension — no./total no. (%) | 156/640 (24.4) | 169/606 (27.9) | 325/1246 (26.1) |
| COPD — no./total no. (%) | 7/640 (1.1) | 11/606 (1.8) | 18/1246 (1.4) |
| Asthma — no./total no. (%) | 76/640 (11.9) | 86/606 (14.2) | 162/1246 (13.0) |
| Chronic kidney disease — no./total no. (%) | 6/640 (0.9) | 4/606 (0.7) | 10/1246 (0.8) |
| Smoker in past year — no./total no. (%) | 83/640 (13.0) | 72/606 (11.9) | 155/1246 (12.4) |
| Cancer — no. (%) | 20 (3.0) | 23 (3.7) | 43 (3.4) |
| Vaccine status — no. (%) | |||
| Not vaccinated | 220 (33.5) | 211 (34.0) | 431 (33.8) |
| Vaccinated — 1 dose | 8 (1.2) | 11 (1.8) | 19 (1.5) |
| Vaccinated — 2+ doses | 428 (65.2) | 399 (64.3) | 827 (64.8) |
| Median no. of days between symptom onset and receipt of fluticasone furoate or placebo (IQR)** | 6 (4–7) | 5 (4–7) | 5 (4–7) |
COPD denotes chronic obstructive pulmonary disease, and IQR interquartile range.
Participants had the option to report sex as male, female, or unknown.
Participants had the option to choose any (or a combination) of the following race and ethnic-group descriptors: American Indian or Alaska Native; Asian; Black, African American, or African; Middle Eastern or North African; Native Hawaiian or Other Pacific Islander; White; None of the above; and Prefer not to answer.
Participants had the option to report their ethnic group as “Hispanic or Latino” or “Not Hispanic or Latino.”
Participants could enroll in the trial or participate in trial visits by contacting a 24-hour call center.
The body-mass index is the weight in kilograms divided by the square of the height in meters.
The distribution of symptoms on trial day 1 at the time of receipt of fluticasone furoate or placebo is shown in Table S2.