RT Journal Article
SR Electronic
T1 Safety and efficacy of ectoine inhalation solution in patients with inflammation and airway obstruction: The EFECT study
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P2166
VO 40
IS Suppl 56
A1 Roman Berndt
A1 Ulrich Sydlik
A1 Andreas Bilstein
A1 Alessandra Marini
A1 Thomas Jaenicke
A1 Gabriele Seitner-Sorge
A1 Sabine Stolz
A1 Jean Krutmann
A1 Ursula Krämer
A1 Klaus Unfried
YR 2012
UL http://erj.ersjournals.com/content/40/Suppl_56/P2166.abstract
AB IntroductionEctoine is a compatible solute used for symptomatic treatment of rhinitis allergica, inflammatory dermatoses and irritated epithelia. Results from different studies demonstrated the efficacy of ectoine in reducing inflammation in the airways. Based on the positive results of a trial with asthmatic patients a study was set up to evaluate Ectoine Inhalation Solution (EIL) in subjects with mild airway obstruction and inflammation.MethodsThe study was designed as double blind, placebo-controlled cross-over trial. Subjects were randomly assigned to EIL or placebo (0.9% saline). Primary endpoint was defined as reduction of inflammatory markers IL 8 and % neutrophilic granulocytes in sputum. Other sputum and breath condensate biomarkers were analysed. QoL and spirometry data were collected on visit days.ResultsReduction of inflammatory markers IL8 and granulocytes was greater after treatment with Ectoin compared to placebo (12% for IL8, 29% for neutrophils). Statistical significance could not be demonstrated. However, total Nitrogen from sputum showed a significant reduction after Ectoin (35%, p=0.02). Other biomarkers included in the investigation indicated advantages for Ectoin (granulocytes), or placebo (TNFα, LTB4, CRP). Analysis of QoL and spirometry data did not show significance to support superiority of one of the treatment arms.No indication for increased health risks could be detected.ConclusionsInhalation of Ectoin can reduce inflammatory markers and shows an excellent safety profile. The results of the EFECT study support the outcome of other studies that the membrane stabilizing Ectoin reduces epithelia derived inflammatory processes.