Table 1. Participants’ Demographic Characteristics, Medical Histories, and Concomitant Medications.
| Characteristic | No. (%) | ||
|---|---|---|---|
| Ciclesonide (n = 197) | Placebo (n = 203) | Overall (N = 400) | |
| Age, mean (SD) [range], y | 43.7 (17.53) [13-87] | 42.9 (16.28) [14-83] | 43.3 (16.89) [13-87] |
| Participants <18 y | 9 (4.6) | 7 (3.4) | 16 (4.0) |
| Sex | |||
| Male | 85 (43.1) | 94 (46.3) | 179 (44.8) |
| Female | 112 (56.9) | 109 (53.7) | 221 (55.3) |
| Race | |||
| Asian | 1 (0.5) | 1 (0.5) | 2 (0.5) |
| Black or African American | 20 (10.2) | 27 (13.3) | 47 (11.8) |
| Native Hawaiian or other Pacific Islander | 1 (0.5) | 2 (1.0) | 3 (0.8) |
| White | 174 (88.3) | 171 (84.2) | 345 (86.3) |
| Multiracial | 0 | 1 (0.5) | 1 (0.3) |
| Othera | 1 (0.5) | 1 (0.5) | 2 (0.5) |
| Ethnicity | |||
| Hispanic or Latino | 86 (43.7) | 86 (42.4) | 172 (43.0) |
| Not Hispanic or Latino | 111 (56.3) | 117 (57.6) | 228 (57.0) |
| Body mass index, mean (SD)b | 28.8 (6.06) | 30.0 (6.87) | 29.4 (6.50) |
| Medical historyc | |||
| Hypertension | 47 (23.9) | 42 (20.7) | 89 (22.3) |
| Drug hypersensitivityd | 21 (10.7) | 30 (14.8) | 51 (12.8) |
| Hyperlipidemia | 20 (10.2) | 16 (7.9) | 36 (9.0) |
| Type 2 diabetes | 22 (11.2) | 8 (3.9) | 30 (7.5) |
| Asthma | 18 (9.1) | 8 (3.9) | 26 (6.5) |
| Selected concomitant medicationse | |||
| Paracetamol | 105 (53.3) | 109 (53.7) | 214 (53.5) |
| Nonsteroidal antiinflammatory drugs | 39 (19.8) | 48 (23.6) | 87 (21.8) |
| Antibiotics | 12 (6.1) | 8 (3.9) | 20 (5.0) |
| Antivirals | 1 (0.5) | 3 (1.5) | 4 (1.0) |
| Monoclonal antibodies | 1 (0.5) | 0 | 1 (0.3) |
| Baseline symptom severityf | |||
| One or more severe symptoms | 5 (2.5) | 9 (4.4) | 14 (3.5) |
| One or more moderate or severe symptoms | 80 (40.6) | 74 (36.5) | 154 (38.5) |
a
Other was a single predefined category.
b
Calculated as weight in kilograms divided by height in meters squared.
c
Medical histories occurring at a difference of more than 2.0% between treatment arms.
d
A reported history of an allergy to any medication.
e
Selected concomitant medications of interest. A medication’s use was considered concomitant if it was initiated or continued after administration of investigational product. Concomitant medications were classified based on the Anatomical and Therapeutic Class of World Health Organization drug, preferred term, and treatment group.
f
Symptoms of cough, dyspnea, chills, and feeling feverish as subjectively rated by participants at time of enrollment.