Pilot safety study of liposomal prostaglandin (PGE1) in respiratory exacerbations in cystic fibrosis.
BACKGROUND
A pilot evaluation to assess the safety and possible benefits of TLC C-53, (prostaglandin E(1) associated with egg phosphatidylcholine liposomes) in acute respiratory exacerbations in children with cystic fibrosis (CF).


METHODS
Randomised, double-blind, placebo-controlled study in 20 P. aeruginosa colonised patients. All received intravenous antibiotics. Subjects were given a rising dose of TLC C-53 (0.15-1.8 microg/kg) by 4 x 1-h infusions. Primary outcome measures were sputum IL-6, IL-8 and sputum neutrophil elastase. The rate of decline in lung function was determined at 6 weeks post-therapy as was the interval until the next respiratory exacerbation requiring intravenous antibiotic therapy.


RESULTS
Analysis of primary and secondary outcome measures failed to show any significant differences between the two groups, although trends favoured the treated group. Decline in lung function over 6 weeks favoured the TLC C-53 group (FEV(1) mean difference 4.3%, 95% CI=-6.8, 15.4%). Time to next exacerbation also favoured the TLC C-53 group with a mean time to exacerbation for TLC C-53 of 26.0 weeks against 11.9 weeks.


CONCLUSIONS
A larger multi-centre trial of TLC C-53 as an adjunct to antibiotic therapy in respiratory exacerbations in CF would appear warranted.
Division of Child Health, Sheffield Children's Hospital, Western Bank, Sheffield S10 2TH, UK.
C J
CJ
Taylor
J
J
McGaw
A S
AS
Rigby
D
D
Threlfall
J
J
Karmel
D000293:Adolescent; D000527:Alprostadil / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D003550:Cystic Fibrosis / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D007262:Infusions, Intravenous; D008081:Liposomes / Q000008:administration & dosage; D008171:Lung Diseases / Q000188:drug therapy; D010713:Phosphatidylcholines / Q000008:administration & dosage; D010865:Pilot Projects; D011552:Pseudomonas Infections / Q000150:complications / Q000188:drug therapy*; D012129:Respiratory Function Tests / Q000379:methods; D013183:Sputum / Q000276:immunology; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000893:Anti-Inflammatory Agents; D008081:Liposomes; D010713:Phosphatidylcholines; D000527:Alprostadil