Addition of inhaled corticosteroids to systemic immunosuppression after lung transplantation: a double-blind, placebo-controlled trial.
BACKGROUND
It is postulated that bronchiolitis obliterans syndrome (BOS) is preceded by airway inflammation that has been described even in stable lung transplant recipients. Airway inflammation is known to be suppressed by inhaled steroids in other chronic inflammatory lung diseases, e.g., asthma and chronic obstructive pulmonary disease. BOS is the major cause of morbidity and mortality after lung transplantation.


OBJECTIVE
To examine the effect of inhaled corticosteroids on the development of BOS in lung transplant recipients.


METHODS
Thirty patients were recruited and randomized in a double-blind fashion to receive either 750 microg of fluticasone propionate (FP) or an identical-appearing placebo twice daily for 3 months; 20 of this group continued until 2 years posttransplantation. Detailed spirometry was performed regularly throughout the study.


RESULTS
In the short-term study no differences were found in any examined parameters. In the long-term component of the study no differences were found in the development of neither BOS nor survival. There were minor differences in bronchoalveolar lavage (BAL) lymphocyte percentages.


CONCLUSIONS
FP is ineffective for the prevention of BOS after lung transplantation despite the airway inflammation that characterizes this condition. Inadequate local delivery, timing of the therapy relative to transplantation and inherent steroid resistance of this condition may explain the negative finding of this study.
Whitford
Helen
H
Department of Respiratory Medicine, The Alfred Hospital, Commercial Road, Prahran, Victoria, Australia 3181.
Walters
E Haydn
EH
Levvey
Bronwyn
B
Kotsimbos
Tom
T
Orsida
Bernadette
B
Ward
Chris
C
Pais
Michael
M
Reid
Sue
S
Williams
Trevor
T
Snell
Greg
G
D000280:Administration, Inhalation; D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001989:Bronchiolitis Obliterans / Q000175:diagnosis / Q000188:drug therapy / Q000517:prevention & control*; D018893:Bronchoalveolar Lavage; D001999:Bronchoscopy; D018572:Disease-Free Survival; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D016040:Lung Transplantation; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000175:diagnosis / Q000188:drug therapy / Q000517:prevention & control
D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D007166:Immunosuppressive Agents; D000068298:Fluticasone