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

NCT03365648 | Completed

• 1 other identifier: LER 02-2017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 17

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.

Conditions

Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• 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.

  At Baseline and after Visit 4 (Week 4)

Secondary Outcomes (12)

• Visual Analogue Scale (VAS) score

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

• Total Symptom Score (TSS) scores

  At Baseline and after Visit 3 (Week 2)

• Number of responders (30% reduction of TSS)

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

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

  From baseline to Visit 6 (Week 16)

• Number of patients using rescue treatment

  From baseline to Visit 6 (Week 16)

Other Outcomes (2)

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

  From baseline to Visit 6 (Week 16)

• Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) total score

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

Study Arms (2)

Lertal® + standard therapy

EXPERIMENTAL

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

Dietary Supplement: Lertal® + standard therapy

Placebo + standard therapy

PLACEBO COMPARATOR

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

Other: Placebo + standard therapy

Interventions

Lertal® + standard therapy 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.

Lertal® + standard therapy

Placebo + standard therapy OTHER

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

Placebo + standard therapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NTC srl: lead

Study Sites (17)

Fondazione IRCCS Policlinico San Matteo

Pavia, (PV), 27100, Italy

Location

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

L’Aquila, AQ, 67100, Italy

Location

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

Bari, BA, 70126, Italy

Location

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

Bari, BA, 70126, Italy

Location

A.O.U. Policlinico Vittorio Emanuele

Catania, CT, 95123, Italy

Location

Istituto Giannina Gaslini

Genova, GE, 16132, Italy

Location

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

Crotone, KR, 88900, Italy

Location

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

Messina, ME, 98124, Italy

Location

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

Garbagnate Milanese, MI, 20042, Italy

Location

Ospedale Civile di Legnano - ASST Ovest Milanese

Legnano, MI, 20162, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Location

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

Milan, MI, 20157, Italy

Location

Ospedale Città di Sesto San Giovanni - ASST Nord Milano

Sesto San Giovanni, MI, 20099, Italy

Location

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

Polistena, RC, 89024, Italy

Location

A.O.U. Policlinico Umberto I

Roma, RM, 00161, Italy

Location

P.O. di Busto Arsizio - ASST Valle Olona

Busto Arsizio, VA, 21051, Italy

Location

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

Napoli, 80138, Italy

Location

Related Publications (1)

• 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.

  PMID: 31319883 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gian Luigi Marseglia, Prof.

  Fondazione IRCCS Policlinico San Matteo di Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 7, 2017
• Study Start: September 15, 2017
• Primary Completion: July 4, 2018
• Study Completion: November 13, 2018
• Last Updated: November 15, 2018

Record last verified: 2018-11

Locations

IT (17)