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

NCT ID: NCT03365648

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2018-11-13

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.

Conditions

Allergic Rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lertal® + standard therapy

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

Group Type: EXPERIMENTAL

Lertal® + standard therapy

Intervention Type: DIETARY_SUPPLEMENT

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.

Placebo + standard therapy

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

Group Type: PLACEBO_COMPARATOR

Placebo + standard therapy

Intervention Type: OTHER

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

Standard therapy: antihistamine

Interventions

Lertal® + standard therapy

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: DIETARY_SUPPLEMENT

Placebo + standard therapy

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

Standard therapy: antihistamine

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NTC srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gian Luigi Marseglia, Prof.

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Policlinico San Matteo di Pavia

Locations

Fondazione IRCCS Policlinico San Matteo

Pavia, (PV), Italy

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

L’Aquila, AQ, Italy

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

Bari, BA, Italy

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

Bari, BA, Italy

A.O.U. Policlinico Vittorio Emanuele

Catania, CT, Italy

Istituto Giannina Gaslini

Genova, GE, Italy

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

Crotone, KR, Italy

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

Messina, ME, Italy

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

Garbagnate Milanese, MI, Italy

Ospedale Civile di Legnano - ASST Ovest Milanese

Legnano, MI, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, MI, Italy

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

Milan, MI, Italy

Ospedale Città di Sesto San Giovanni - ASST Nord Milano

Sesto San Giovanni, MI, Italy

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

Polistena, RC, Italy

A.O.U. Policlinico Umberto I

Roma, RM, Italy

P.O. di Busto Arsizio - ASST Valle Olona

Busto Arsizio, VA, Italy

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

Napoli, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 31319883 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LER 02-2017

Identifier Type: -

Identifier Source: org_study_id