14 May 2024 : Original article
Association Between FEV₁ Decline Rate and Mortality in Long-Term Follow-Up of a 21-Patient Pilot Clinical Trial of Inhaled Liposomal Cyclosporine Plus Standard-of-Care Versus Standard-of-Care Alone for Bronchiolitis Obliterans Syndrome After Lung Transplantation
Aldo Iacono1ABDEF*, Marniker Wijesinha
2DE, Andreas Völp 3CD, Maksim Korotun1D, Michael Terrin2AD
DOI: 10.12659/AOT.942823
Ann Transplant 2024; 29:e942823
Table 1 Baseline participant characteristics.
| Total (n=21) | ||
|---|---|---|
| Sex | Female | 7 (33.3%) |
| Male | 14 (66.7%) | |
| Age at screening, years (mean±SD) | 61.3±13.3 | |
| Range | 32–81 | |
| Ethnic group | African American | 5 (23.8%) |
| Caucasian | 16 (76.2%) | |
| Underlying disease | Chronic obstructive pulmonary disease | 6 (28.6%) |
| Idiopathic pulmonary fibrosis | 12 (57.1%) | |
| Other | 3 (14.3%) | |
| BOS grade at screening | 1 | 13 (61.9%) |
| 2 | 8 (38.1%) | |
| Type of lung transplantation | Single | 11 (52.4%) |
| Double | 10 (47.6%) | |
| Maximum FEV1 after lung transplantation, L (mean±SD) | 2.47±0.62 | |
| Range | 1.37–3.76 | |
| FEV1 at baseline/randomization, L (mean±SD) | 1.70±0.55 | |
| Range | 1.06–3.02 | |
| Treatment during intervention period | L-CsA-I | 11 (52.4%) |
| SOC | 10 (47.6%) | |
| BOS – bronchiolitis obliterans syndrome; FEV – forced expiratory volume in 1 second; L-CsA-I – inhaled liposomal cyclosporine A; SOC – standard of care. | ||