Background: Lertal®, an oral nutraceutical, contains extract of Perilla, quercetin, and Vitamin D3. The current polycentric, randomized, parallel-group, controlled study aimed in the Phase II to evaluate the efficacy and safety of Lertal® in preventing allergic rhinitis (AR) exacerbations in children after the end of the pharmacological treatment phase. Materials and methods: One hundred twenty-eight children completed Phase II. Sixty-four children continued Lertal® treatment (Lertal® Group: LG) and 64 ones did not assume any medication (Observation Group: OG) for 4-12 weeks. The study endpoints were the number, intensity, and duration of AR exacerbations, and the length of symptom-free time. Results: Children of LG halved the risk (HR = 0.54) of having AR exacerbation. Children of LG had significantly (p = 0.039) less AR exacerbations than OG children. In children with AR exacerbations, the total number of days in which each patient took at least one rescue medication was significantly (p = 0.018) lesser in LG children than OG ones. In the global population, the cumulative days treated with rescue medication was significantly (p < 0.0001) higher in OG than in LG. There was no clinically relevant adverse event. Conclusions: The present study documented that prolonged Lertal® assumption was safe and able to significantly reduce, such as halving, the risk of AR exacerbation, their duration and the use of rescue medications, after the suspension of the one-month antihistamine treatment. Therefore, Lertal® could be envisaged as an effective preventive treatment in AR children able to guarantee long symptom-free time. Trial registration: Clinical trial registration: ClinicalTrials gov ID NCT03365648.
A polycentric, randomized, parallel-group, study on Lertal®, a multicomponent nutraceutical, as preventive treatment in children with allergic rhinoconjunctivitis: Phase II
Miraglia Del Giudice M.;
2019
Abstract
Background: Lertal®, an oral nutraceutical, contains extract of Perilla, quercetin, and Vitamin D3. The current polycentric, randomized, parallel-group, controlled study aimed in the Phase II to evaluate the efficacy and safety of Lertal® in preventing allergic rhinitis (AR) exacerbations in children after the end of the pharmacological treatment phase. Materials and methods: One hundred twenty-eight children completed Phase II. Sixty-four children continued Lertal® treatment (Lertal® Group: LG) and 64 ones did not assume any medication (Observation Group: OG) for 4-12 weeks. The study endpoints were the number, intensity, and duration of AR exacerbations, and the length of symptom-free time. Results: Children of LG halved the risk (HR = 0.54) of having AR exacerbation. Children of LG had significantly (p = 0.039) less AR exacerbations than OG children. In children with AR exacerbations, the total number of days in which each patient took at least one rescue medication was significantly (p = 0.018) lesser in LG children than OG ones. In the global population, the cumulative days treated with rescue medication was significantly (p < 0.0001) higher in OG than in LG. There was no clinically relevant adverse event. Conclusions: The present study documented that prolonged Lertal® assumption was safe and able to significantly reduce, such as halving, the risk of AR exacerbation, their duration and the use of rescue medications, after the suspension of the one-month antihistamine treatment. Therefore, Lertal® could be envisaged as an effective preventive treatment in AR children able to guarantee long symptom-free time. Trial registration: Clinical trial registration: ClinicalTrials gov ID NCT03365648.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
