BACKGROUND: Patients are often dissatisfied with the symptom control obtained from available pharmacological treatments for seasonal allergic rhinoconjunctivitis (ARC). Therefore, patients seek for alternative, nonpharmacological options to treat their symptoms. Here, we assessed the efficacy of ectoine nasal spray and ectoine eye drops in comparison to placebo to prevent nasal and ocular symptoms following exposure to pollen in patients with ARC. METHODS: In this double-blind, randomized, placebo-controlled, cross-over study, 46 patients with ARC applied ectoine eye drops and nasal spray in immediate succession orplacebo eye drops and nasal spray for 13 days before ARC symptoms were induced in an environmental exposure chamber. Primary endpoint was the baseline-adjusted area under the curve (AUC) posttreatment total nasal symptom score (TNSS) and the total ocular symptom score (TOSS) using analysis of covariance. Secondary endpoints were, amongst others, total nonnasal symptoms score (TNNSS) and nasal patency (measured using acoustic rhinometry). RESULTS: Treatment with both ectoine and placebo reduced TNSS, TOSS, and TNNSS upon allergen exposure. The analysis of parameters at baseline and after allergen exposure demonstrated that ectoine induced a clinically relevant improvement in ARC symptoms compared to placebo: the least square mean difference for baseline-adjusted AUC was -1.87 for TNSS, -1.45 for TOSS and -2.20 for TNNSS. The mean change from baseline AUC of TNNSS for ectoine was also significantly greater than for placebo (-5.49 vs. -3.46; p = 0.011). Ectoine significantly improved the singular symptoms "sneezing," "watery eyes" and "itchy eyes" (p ≤ 0.021) as well as "itchy ear/palate" (p = 0.036) in comparison to placebo. Mean cross sectional areas of the nasal cavity were reduced to a lesser extent after treatment with ectoine (-0.020 ± 0.022) than with placebo (-0.047 ± 0.029). The current study also demonstrated a very good safety profile of ectoine treatment. Few AEs with comparable numbers in both treatment groups were reported during the study, which were mild in severity and resolved without medical treatment. CONCLUSION: The study suggests that ectoine is effective in reducing nasal and ocular symptoms associated with ARC. Being a natural, bacteria derived stress protection molecule functioning by a physical mode of action, it therefore represents an alternative nonpharmacological treatment option.
RCT Entities:
BACKGROUND:Patients are often dissatisfied with the symptom control obtained from available pharmacological treatments for seasonal allergic rhinoconjunctivitis (ARC). Therefore, patients seek for alternative, nonpharmacological options to treat their symptoms. Here, we assessed the efficacy of ectoine nasal spray and ectoine eye drops in comparison to placebo to prevent nasal and ocular symptoms following exposure to pollen in patients with ARC. METHODS: In this double-blind, randomized, placebo-controlled, cross-over study, 46 patients with ARC applied ectoine eye drops and nasal spray in immediate succession or placebo eye drops and nasal spray for 13 days before ARC symptoms were induced in an environmental exposure chamber. Primary endpoint was the baseline-adjusted area under the curve (AUC) posttreatment total nasal symptom score (TNSS) and the total ocular symptom score (TOSS) using analysis of covariance. Secondary endpoints were, amongst others, total nonnasal symptoms score (TNNSS) and nasal patency (measured using acoustic rhinometry). RESULTS: Treatment with both ectoine and placebo reduced TNSS, TOSS, and TNNSS upon allergen exposure. The analysis of parameters at baseline and after allergen exposure demonstrated that ectoine induced a clinically relevant improvement in ARC symptoms compared to placebo: the least square mean difference for baseline-adjusted AUC was -1.87 for TNSS, -1.45 for TOSS and -2.20 for TNNSS. The mean change from baseline AUC of TNNSS for ectoine was also significantly greater than for placebo (-5.49 vs. -3.46; p = 0.011). Ectoine significantly improved the singular symptoms "sneezing," "watery eyes" and "itchy eyes" (p ≤ 0.021) as well as "itchy ear/palate" (p = 0.036) in comparison to placebo. Mean cross sectional areas of the nasal cavity were reduced to a lesser extent after treatment with ectoine (-0.020 ± 0.022) than with placebo (-0.047 ± 0.029). The current study also demonstrated a very good safety profile of ectoine treatment. Few AEs with comparable numbers in both treatment groups were reported during the study, which were mild in severity and resolved without medical treatment. CONCLUSION: The study suggests that ectoine is effective in reducing nasal and ocular symptoms associated with ARC. Being a natural, bacteria derived stress protection molecule functioning by a physical mode of action, it therefore represents an alternative nonpharmacological treatment option.