Table 1.
Clinical characteristics of the study participants at baseline
| All Participants (N=73) | |
|---|---|
| Sex, n (%) | |
| Female | 40 (54.8%) |
| Age (years), mean (SD) | 22.6(9.1) |
| Age distribution, n (%) | |
| >10–18 years | 29 (39.7%) |
| > 18–30 years | 28 (38.4%) |
| >30 years | 16(21.9%) |
| Race, n (%) | |
| Caucasian | 64 (87.7%) |
| Hispanic | 6 (8.2%) |
| African-American | 2 (2.7%) |
| Unknown/Other | 1 (1.4%) |
| Genotype, n (%) | |
| F508del Homozygous | 39 (53.4%) |
| F508del Heterozygous | 27 (37.0%) |
| Other/Unknown [1] | 7 (9.6%) |
| BMI (kg/m2), mean (SD) | 21.4(3.9) |
| FEV1 % Predicted [2], mean (SD) | 74.1% (14.4%) |
| FEV1 % Predicted distribution, n (%) | |
| <70% | 23(31.5%) |
| >70–<90% | 44 (60.3%) |
| >90% | 6 (8.2%) |
| Chronic Inhaled Antibiotics [3], n (%) | 40 (54.8%) |
| Chronic Azithromycin [3], n (%) | 34 (46.6%) |
[1]
Other refers to participants with either two known, non-F508del CF mutations, or one known, non-F508del CF mutation and one unidentified allele which has not been classified as a CF mutation.
[2]
FEV1 % predicted is calculated using the Global Lung Initiative reference equations.
[3]
Chronic is defined as initiated ≥8 weeks prior to randomization.