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

Primary Purpose

Allergic Rhinoconjunctivitis

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Lertal® + standard therapy

Placebo + standard therapy

About this trial

This is an interventional treatment trial for Allergic Rhinoconjunctivitis

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 6 to 12 years
Male or female
Diagnosis of allergic rhinoconjunctivitis
Hypersensitivity to dust mites or pollen confirmed with skin-prick test (wheal and redness, ≥ 3 mm more extended than control) performed in the previous 12 months
Total Symptoms Score (TSS) ≥ 15 and at least 1 for nasal congestion
Written informed consent of patient and of parent or legal guardian

Exclusion Criteria:

Uncontrolled asthma
Secondary rhinitis to other causes
Documented evidence of acute or chronic sinusitis
Nasal polyps
Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or topical corticosteroids
Use of leukotriene antagonists
Continuous use of antihistamines
Inadequate washout of drugs:
- Systemic or intranasal corticosteroids: 1 month
- Leukotriene antagonists: 1 month
- Sodium cromoglycate: 2 weeks
- Systemic or intranasal decongestants: 3 days
- Cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine: 5-10 days
Malformations of the nose, ear or throat
Upper or lower respiratory tract infection in the last 2 weeks
Participation in other clinical studies in the last month
Documented hypersensitivity to the study product or its excipients
Trip planned outside of the study area

Sites / Locations

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"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lertal® + standard therapy

Placebo + standard therapy

Arm Description

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)

Outcomes

Primary Outcome Measures

Total Symptom Score (TSS) scores

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.

Secondary Outcome Measures

Visual Analogue Scale (VAS) score

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.

Total Symptom Score (TSS) scores

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.

Number of responders (30% reduction of TSS)

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

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.

Number of patients using rescue treatment

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.

Total Nasal Symptom Score (TNSS)

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.

Total Ocular Symptom Score (TOSS)

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.

Total Throat Symptom Score (TTSS)

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.

Number of patients symptom-free or with mild symptoms

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.

Number of exacerbations

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

Intensity (mild, moderate, severe) of exacerbations

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

Duration (number of days) of exacerbations

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

Full Information

NCT ID

NCT03365648

First Posted

November 22, 2017

Last Updated

November 14, 2018

Sponsor

NTC srl

1. Study Identification

Unique Protocol Identification Number

NCT03365648

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

September 15, 2017 (Actual)

Primary Completion Date

July 4, 2018 (Actual)

Study Completion Date

November 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NTC srl

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.

Detailed Description

Allergic rhinoconjunctivitis (AR) is a common chronic disorder in children, especially in developed countries. It is not characterized by nasal symptoms only (such as congestion and sneezing), but may also cause general complaints such as fatigue and cough. AR can also have detrimental effects on mood, sleep, social activities and scholastic performance. Lertal® is a novel nutraceutical containing seed extracts from Perilla Frutescens, Quercetin extracted from Sophora japonica and Vitamin D3, all compounds that have demonstrated their ability to reduce allergy symptoms and the use of anti-allergy drugs in adults. The aim of this randomized, double-blinded, parallel-group, placebo-controlled study is to evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinoconjunctivitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A randomized, double-blinded, parallel-group, placebo-controlled clinical study

Masking

ParticipantInvestigator

Masking Description

Double-blinded

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lertal® + standard therapy

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo + standard therapy

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Lertal® + standard therapy

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo + standard therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Total Symptom Score (TSS) scores

Description

Time Frame

At Baseline and after Visit 4 (Week 4)

Secondary Outcome Measure Information:

Title

Visual Analogue Scale (VAS) score

Description

Time Frame

At Baseline, after Visit 3 (Week 2) and after Visit 4 (Week 4)

Title

Total Symptom Score (TSS) scores

Description

Time Frame

At Baseline and after Visit 3 (Week 2)

Title

Number of responders (30% reduction of TSS)

Description

Time Frame

After Visit 3 (Week 2) and after Visit 4 (Week 4)

Title

Time to maximum effect on Total Symptom Score (TSS) vs placebo

Description

Time Frame

From baseline to Visit 6 (Week 16)

Title

Number of patients using rescue treatment

Description

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.

Time Frame

From baseline to Visit 6 (Week 16)

Title

Total Nasal Symptom Score (TNSS)

Description

Time Frame

At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4)

Title

Total Ocular Symptom Score (TOSS)

Description

Time Frame

At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4)

Title

Total Throat Symptom Score (TTSS)

Description

Time Frame

At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4)

Title

Number of patients symptom-free or with mild symptoms

Description

Time Frame

From V3 (Week 2) to Visit 4 (Week 4)

Title

Number of exacerbations

Description

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

Time Frame

From Visit 5 (Week 8) to Visit 6 (Week 16)

Title

Intensity (mild, moderate, severe) of exacerbations

Description

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

Time Frame

From Visit 5 (Week 8) to Visit 6 (Week 16)

Title

Duration (number of days) of exacerbations

Description

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

Time Frame

From Visit 5 (Week 8) to Visit 6 (Week 16)

Other Pre-specified Outcome Measures:

Title

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) recorded throughout the study

Description

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

Time Frame

From baseline to Visit 6 (Week 16)

Title

Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) total score

Description

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.

Time Frame

At Baseline, at Visit 4 (Week 4) and at Visit 5 (Week 8) or Visit 6 (Week 16)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 6 to 12 years Male or female Diagnosis of allergic rhinoconjunctivitis Hypersensitivity to dust mites or pollen confirmed with skin-prick test (wheal and redness, ≥ 3 mm more extended than control) performed in the previous 12 months Total Symptoms Score (TSS) ≥ 15 and at least 1 for nasal congestion Written informed consent of patient and of parent or legal guardian Exclusion Criteria: Uncontrolled asthma Secondary rhinitis to other causes Documented evidence of acute or chronic sinusitis Nasal polyps Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or topical corticosteroids Use of leukotriene antagonists Continuous use of antihistamines Inadequate washout of drugs: Systemic or intranasal corticosteroids: 1 month Leukotriene antagonists: 1 month Sodium cromoglycate: 2 weeks Systemic or intranasal decongestants: 3 days Cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine: 5-10 days Malformations of the nose, ear or throat Upper or lower respiratory tract infection in the last 2 weeks Participation in other clinical studies in the last month Documented hypersensitivity to the study product or its excipients Trip planned outside of the study area

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gian Luigi Marseglia, Prof.

Organizational Affiliation

Fondazione IRCCS Policlinico San Matteo di Pavia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondazione IRCCS Policlinico San Matteo

City

Pavia

State/Province

(pv)

ZIP/Postal Code

27100

Country

Italy

Facility Name

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

City

L'Aquila

State/Province

ZIP/Postal Code

67100

Country

Italy

Facility Name

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

City

Bari

State/Province

ZIP/Postal Code

70126

Country

Italy

Facility Name

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

City

Bari

State/Province

ZIP/Postal Code

70126

Country

Italy

Facility Name

A.O.U. Policlinico Vittorio Emanuele

City

Catania

State/Province

ZIP/Postal Code

95123

Country

Italy

Facility Name

Istituto Giannina Gaslini

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

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

City

Crotone

State/Province

ZIP/Postal Code

88900

Country

Italy

Facility Name

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

City

Messina

State/Province

ZIP/Postal Code

98124

Country

Italy

Facility Name

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

City

Garbagnate Milanese

State/Province

ZIP/Postal Code

20042

Country

Italy

Facility Name

Ospedale Civile di Legnano - ASST Ovest Milanese

City

Legnano

State/Province

ZIP/Postal Code

20162

Country

Italy

Facility Name

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

City

Milano

State/Province

ZIP/Postal Code

20122

Country

Italy

Facility Name

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

City

Milano

State/Province

ZIP/Postal Code

20157

Country

Italy

Facility Name

Ospedale Città di Sesto San Giovanni - ASST Nord Milano

City

Sesto San Giovanni

State/Province

ZIP/Postal Code

20099

Country

Italy

Facility Name

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

City

Polistena

State/Province

ZIP/Postal Code

89024

Country

Italy

Facility Name

A.O.U. Policlinico Umberto I

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

P.O. di Busto Arsizio - ASST Valle Olona

City

Busto Arsizio

State/Province

ZIP/Postal Code

21051

Country

Italy

Facility Name

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

City

Napoli

ZIP/Postal Code

80138

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

31319883

Citation

Marseglia G, Licari A, Leonardi S, Papale M, Zicari AM, Schiavi L, Ciprandi G; Italian Study Group on Pediatric Allergic Rhinoconjunctivitis. A polycentric, randomized, parallel-group, study on Lertal(R), a multicomponent nutraceutical, as preventive treatment in children with allergic rhinoconjunctivitis: phase II. Ital J Pediatr. 2019 Jul 18;45(1):84. doi: 10.1186/s13052-019-0678-y.

Results Reference

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

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