title: Liposomes: a new non-pharmacological therapy concept for seasonal-allergic-rhinoconjunctivitis.
abstract: Mucosal barrier disorders play an important role in the pathomechanism of the allergic disease. A new approach for their treatment uses liposomes, which consist of phospholipids that make up 75% of the protective nasal surfactant layer. Our aim was to investigate the efficacy of liposomal-based therapy, as a comprehensive treatment alternative to guideline cromoglycate-based therapy, in the treatment of seasonal allergic rhinoconjunctivitis (SAR). We compared nasal and conjunctival symptom reduction with LipoNasal n nasal spray used as monotherapy (LNM), or LipoNasal n nasal spray and Tears Again eye spray combination therapy (LTC), against standard cromoglycate combination therapy (CGC). This prospective, controlled, open observational study was conducted monocentrically. According to their symptoms and preferences 72 patients with SAR were distributed in three equal groups. The study comprised two visits at an interval of 7 days. The efficacy was examined by daily documenting nasal and conjunctival symptom scores. The Nasal-Spray-Sensory-Scale and the Eye-Drops/Spray-Sensory-Scale were used to investigate the tolerability. Quality of life (QoL) was evaluated, using the RHINASTHMA QoL German adapted version. LNM achieved significant improvement in nasal (p < 0.001) and conjunctival symptoms (p = 0.050). The symptom reduction using CGC was equally significant. LTC led to significant nasal symptom relief (p = 0.045). QoL did not improve significantly in all groups (p > 0.05). The tolerability of all treatments was good and no adverse reactions were observed. In all treatment groups the improvement of the nasal and conjunctival symptom scores exceeds the minimal clinically important difference (MCID). The results demonstrate good tolerability and efficacy of non-pharmaceutical liposomal-based treatment (LipoNasal n and Tears Again), given as monotherapy or combination therapy, for nasal and conjunctival symptoms caused by SAR. This study indicates that liposomal-based treatment for SAR may be a comparable alternative to cromoglycate therapy. Further studies are needed to verify these findings.
authors.affiliation: Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), University of Cologne, 50924, Cologne, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Böhm
authors.forename: G
authors.initials: G
authors.lastname: Avgitidou
authors.forename: E
authors.initials: E
authors.lastname: El Hassan
authors.forename: R
authors.initials: R
authors.lastname: Mösges
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage; D003233:Conjunctivitis, Allergic; D004205:Cromolyn Sodium / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008081:Liposomes / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D059085:Nasal Sprays; D009883:Ophthalmic Solutions; D006255:Rhinitis, Allergic, Seasonal; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D008081:Liposomes; D059085:Nasal Sprays; D009883:Ophthalmic Solutions; D004205:Cromolyn Sodium