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
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View abstract on PubMed
Summary
This summary is machine-generated.In bronchiolitis obliterans syndrome (BOS), declining lung function (forced expiratory volume in 1 second, FEV1) predicts higher mortality risk. Inhaled liposomal cyclosporine A (L-CsA-I) showed trends toward stabilizing FEV1 and improving survival.
Area Of Science
- Pulmonology
- Transplantation Medicine
- Clinical Trials
Background
- Bronchiolitis Obliterans Syndrome (BOS) is a major cause of lung transplant failure.
- The relationship between lung function trajectory and mortality in BOS is not well understood.
- Longitudinal data from a clinical trial of inhaled liposomal cyclosporine A (L-CsA-I) for BOS patients is available.
Purpose Of The Study
- To investigate the association between longitudinal forced expiratory volume in 1 second (FEV1) change and mortality in lung transplant recipients with BOS.
- To evaluate the impact of L-CsA-I on FEV1 trajectory and survival in BOS patients.
Main Methods
- A joint statistical model combining linear mixed models for FEV1 and Cox regression for mortality was used.
- Data from 21 BOS patients randomized to L-CsA-I plus standard-of-care (SOC) or SOC alone were analyzed.
- Median follow-up was 35 months post-randomization.
Main Results
- A 1% decline in FEV1 was associated with a 1.076-fold increased mortality risk (p=0.058).
- FEV1 decline was reduced by 2.6% annually in the L-CsA-I group compared to SOC (p=0.210).
- Survival rates at 5 years were 27% for L-CsA-I and 0% for SOC (p=0.164).
Conclusions
- Greater longitudinal FEV1 decline is a predictor of increased mortality in BOS patients.
- L-CsA-I demonstrated trends towards stabilizing FEV1 and improving long-term survival.
- FEV1 change warrants further evaluation as a prognostic marker for BOS management and clinical trial design.
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