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

Novelty. Technology. Care. (NTC)

Status: Completed

Conditions: Allergic Rhinoconjunctivitis

Treatments: Other: Placebo + standard therapy; Dietary Supplement: Lertal® + standard therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03365648

LER 02-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Lertal® + standard therapy

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lertal® + standard therapy

Placebo + standard therapy

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo + standard therapy