Lertal® double-layer tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine)

Placebo tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine)

Allergic Rhinoconjunctivitis

Lertal® is a novel food supplement. Each tablet contains the following active ingredients:
Quercetin 150 mg: a natural flavonoid that inhibits the release of histamine, leukotrienes, PGD2, IL (IL-6, IL-8, TNF-alpha).
Perilla frutescens 80 mg: A dry extract of the seeds containing rosmarinic acid, luteolin, apigenin and crysoeriol that inhibits the release of histamine and expression of interleukins (IL-6, TNF-alpha).
Vitamin D3 5 mcg (200 IU), which contributes to the normal function of the immune system.
Standard therapy: antihistamine.

Lertal® + standard therapy

Placebo tablet identical in appearance, size and taste to Lertal® tablets. Standard therapy: antihistamine.
Standard therapy: antihistamine

Placebo + standard therapy

Fondazione IRCCS Policlinico San Matteo

Ospedale regionale San Salvatore - ASL 1 Avezzano Sulmona L'Aquila

A.O.U. Consorziale "Policlinico Giovanni XXIII"

A.O.U. Consorziale "Policlinico-Giovanni XXIII"

A.O.U. Policlinico Vittorio Emanuele

Istituto Giannina Gaslini

P.O. San Giovanni di Dio - ASP di Crotone

A.O.U. Policlinico "G. Martino"

P.O. G. Salvini di Garbagnate Milanese - ASST Rhodense

Ospedale Civile di Legnano - ASST Ovest Milanese

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Ospedale San Carlo Borromeo - ASST Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo

Ospedale Città di Sesto San Giovanni - ASST Nord Milano

Ospedale di Polistena "Santa Maria degli Ungheresi" - ASP di Reggio Calabria

A.O.U. Policlinico Umberto I

P.O. di Busto Arsizio - ASST Valle Olona

Az. Osp. Univ. dell'Università degli Studi della Campania "Luigi Vanvitelli"

Efficacy and Safety of Lertal® as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics

A Randomized, Double-blinded, Parallel-group, Placebo-controlled Clinical Study of the Efficacy and Safety of an Oral Nutraceutical (Lertal®) as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics

Changes from baseline of Total Symptom Score (TSS) scores will be calculated after 4 weeks of treatment. The Total Symptoms score is a patient-reported evaluation of nine symptoms:
Nasal symptoms (Total Nasal Symptom Score): itching, sneezing, rhinorrhea, nasal congestion
Ocular symptoms (Total Ocular Symptom Score): itching, hyperemia of conjunctiva, tearing
Throat symptoms (Total Throat Symptom Score): itching, coughing
With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks.
The total symptom score is the sum of the scores of nasal symptoms, ocular symptoms and throat symptoms.
The between-group analysis will be performed by means of a t-test for independent samples or analogous non-parametric test.

The patient will be asked to indicate overall system distress on a 100 mm Visual Analogue Scale (VAS) were 0 is equal to no discomfort and 100 the worst possible discomfort. Change from baseline of Visual Analogue Scale (VAS) score after 2 and 4 weeks of treatment. The between-group analysis will be performed using a t-test for independent samples or analogous nonparametric test.

Change from baseline of Total Symptom Score (TSS) scores after 2 weeks of treatment. The Total Symptoms score is a patient-reported evaluation of nine symptoms:
Nasal symptoms (Total Nasal Symptom Score): itching, sneezing, rhinorrhea, nasal congestion
Ocular symptoms (Total Ocular Symptom Score): itching, hyperemia of conjunctiva, tearing
Throat symptoms (Total Throat Symptom Score): itching, coughing
With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks.
The total symptom score is the sum of the scores of nasal symptoms, ocular symptoms and throat symptoms.
The between-group analysis will be performed by means of a t-test for independent samples or analogous non-parametric test.

Change from baseline of TSS score for each patient after 2 and 4 weeks of treatment will be classified as ≥ 30% and < 30%, thus defining responder and non-responder patients. Between-group differences will be tested by means of a Chi-square test with 2x2 contingency tables.

Time to maximum effect on Total Symptom Score (TSS) vs placebo will be analysed by means of t-test for independent samples after logtransformation of the data or analogous non-parametric test. The Total Symptoms score is a patient-reported evaluation of nine symptoms:
Nasal symptoms (Total Nasal Symptom Score): itching, sneezing, rhinorrhea, nasal congestion
Ocular symptoms (Total Ocular Symptom Score): itching, hyperemia of conjunctiva, tearing
Throat symptoms (Total Throat Symptom Score): itching, coughing
With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks.
The total symptom score is the sum of the scores of nasal symptoms, ocular symptoms and throat symptoms.

Between-group differences in the number of patients using rescue treatment will be analyzed by means of a Chi-square test with 2x2 contingency tables.

The Total Nasal Symptom Score is a patient-reported evaluation of the following symptoms: itching, sneezing, rhinorrhea, nasal congestion. With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks.
Changes from baseline in Total Nasal Symptom Score (TNSS) scores will be calculated after 2 and 4 weeks of treatment and between-group differences analyzed using a t-test for independent samples or analogous non-parametric test.

The Total Ocular Symptom Score is a patient-reported evaluation of the following symptoms: itching, hyperemia of conjunctiva, tearing. With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks.
Changes from baseline in Total Ocular Symptom Score (TOSS) scores will be calculated after 2 and 4 weeks of treatment and between-group differences analyzed using a t-test for independent samples or analogous non-parametric test.

The Total Throat Symptom Score is a patient-reported evaluation of the following symptoms: itching, coughing. With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks.
Changes from baseline in Total Throat Symptom Score (TTSS) scores will be calculated after 2 and 4 weeks of treatment and between-group differences analyzed using a t-test for independent samples or analogous non-parametric test.

The number of patients with score for a single symptom ≤ 1 will be calculated and the between-group differences analyzed by means of a Chi-square test with 2xn contingency tables, where n represents the number of observations.

Exacerbations are defined as the need of an antihistamine medication of any kind, at any dose and of any duration.

The incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) recorded throughout the study will be presented overall and by treatment group respectively.

The Pediatric Rhinoconjunctivitis Quality of Life Questionnaire consists of 23 questions in 5 domains (nasal symptoms, ocular symptoms, practical issues, limitation of activities, other symptoms), that are answered on a 7-point scale (0-6), where 0 represents the absence of problems and 6 the greatest symptom distress. Changes from baseline of the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire total score will be calculated at Visit 4 (Week 4) and at Visit 5 (Week 8) or Visit 6 (Week16). An analysis of variance for repeated measures will be adopted, isolating the variability due to type of allergy, treatment group, time of observation and their interaction.

perilla/epuizare

Efficacy and Safety of Lertal® as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics

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