Fig 1.
Flow chart of the randomized controlled trial of montelukast versus placebo in LTx patients with BOS.
IIT = intention to treat analysis.
Table 1.
Patient characteristics of the montelukast and placebo group.
Values are presented as n-value (percentage) or mean (standard error of mean). AZA = azathioprine, BMI = body mass index, BOS = bronchiolitis obliterans syndrome, CF = cystic fibrosis, CLAD = chronic lung allograft dysfunction, CRP = C-reactive protein,CsA = cyclosporine A, FK = tacrolimus, HLTx = heart-lung transplantation, ILD = interstitial lung disease, MMF = mycophenolate mofetil, n = n-value, PHT = pulmonary arterial hypertension, POD = post-operative day, SLTx = single lung transplantation, SSLTx = double lung transplantation.
Table 2.
Patient characteristics of the montelukast and placebo group (BOS stage I only).
Values are presented as n-value (percentage) or mean (standard error of mean). AZA = azathioprine, BMI = body mass index, BOS = bronchiolitis obliterans syndrome, CF = cystic fibrosis, CLAD = chronic lung allograft dysfunction, CRP = C-reactive protein, CsA = cyclosporine A, FK = tacrolimus, HLTx = heart-lung transplantation, ILD = interstitial lung disease, MMF = mycophenolate mofetil, n = n-value, PHT = pulmonary arterial hypertension, POD = post-operative day, SLTx = single lung transplantation, SSLTx = double sided lung transplantation.
Fig 2.
Kaplan-Meier survival curve of the placebo and the montelukast arm at 2 years.
Fig 3.
FEV1 evolution (% predicted, absolute value) comparing montelukast to placebo.
MLK = montelukast. Dotted line is the time-point of inclusion.
Table 3.
Long function evolution of the montelukast and placebo group.
Patients were subdivided in stable (110%-90% FEV1 compared to the FEV1 at the moment of CLAD diagnosis), increase (>110%) and decrease (<90%), no difference was observed (p = 0.16). No result = no result could be obtained in 2 patients in the placebo group and 3 patients in the montelukast groups due to mortality, concurrent infection, missed appointment. MLK = montelukast.
Fig 4.
FEV1 evolution (% predicted, absolute value) comparing montelukast to placebo in BOS stage 1 patients (upper part) and BOS stage 2 and 3 (lower part).
MLK = montelukast. Dotted line is the time-point of inclusion.