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Completed

NCT Number: NCT03365648

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

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.

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Key information

Conditions

Allergic Rhinoconjunctivitis

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico San Matteo, Pavia, (PV), Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo + standard therapy

Other

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

Standard therapy: antihistamine

Primary outcomes

  1. Total Symptom Score (TSS) scores

    Time frame: At Baseline and after Visit 4 (Week 4)

    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 outcomes

  1. Visual Analogue Scale (VAS) score

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

    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.

  2. Total Symptom Score (TSS) scores

    Time frame: At Baseline and after Visit 3 (Week 2)

    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.

  3. Number of responders (30% reduction of TSS)

    Time frame: After Visit 3 (Week 2) and after Visit 4 (Week 4)

    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.

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

    Time frame: From baseline to Visit 6 (Week 16)

    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.

  5. Number of patients using rescue treatment

    Time frame: From baseline to Visit 6 (Week 16)

    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.

  6. Total Nasal Symptom Score (TNSS)

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

    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.

  7. Total Ocular Symptom Score (TOSS)

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

    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.

  8. Total Throat Symptom Score (TTSS)

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

    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.

  9. Number of patients symptom-free or with mild symptoms

    Time frame: From V3 (Week 2) to Visit 4 (Week 4)

    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.

  10. Number of exacerbations

    Time frame: From Visit 5 (Week 8) to Visit 6 (Week 16)

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

  11. Intensity (mild, moderate, severe) of exacerbations

    Time frame: From Visit 5 (Week 8) to Visit 6 (Week 16)

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

  12. Duration (number of days) of exacerbations

    Time frame: From Visit 5 (Week 8) to Visit 6 (Week 16)

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

Other outcomes

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

    Time frame: From baseline to Visit 6 (Week 16)

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

  2. Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) total score

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

    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.

Sponsors and collaborators

Lead sponsor

NTC srl

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 7, 2017
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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