Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 89 of 1210 for:    HISTAMINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03365648
Recruitment Status : Completed
First Posted : December 7, 2017
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
NTC srl

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinoconjunctivitis Dietary Supplement: Lertal® + standard therapy Other: Placebo + standard therapy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-blinded, parallel-group, placebo-controlled clinical study
Masking: Double (Participant, Investigator)
Masking Description: Double-blinded
Primary Purpose: Treatment
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
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : July 4, 2018
Actual Study Completion Date : November 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lertal® + standard therapy
Lertal® double-layer tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine)
Dietary Supplement: 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.


Placebo Comparator: Placebo + standard therapy
Placebo tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine)
Other: Placebo + standard therapy

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

Standard therapy: antihistamine





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365648


Locations
Layout table for location information
Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, (pv), Italy, 27100
Ospedale regionale San Salvatore - ASL 1 Avezzano Sulmona L'Aquila
L'Aquila, AQ, Italy, 67100
A.O.U. Consorziale "Policlinico Giovanni XXIII"
Bari, BA, Italy, 70126
A.O.U. Consorziale "Policlinico-Giovanni XXIII"
Bari, BA, Italy, 70126
A.O.U. Policlinico Vittorio Emanuele
Catania, CT, Italy, 95123
Istituto Giannina Gaslini
Genova, GE, Italy, 16132
P.O. San Giovanni di Dio - ASP di Crotone
Crotone, KR, Italy, 88900
A.O.U. Policlinico "G. Martino"
Messina, ME, Italy, 98124
P.O. G. Salvini di Garbagnate Milanese - ASST Rhodense
Garbagnate Milanese, MI, Italy, 20042
Ospedale Civile di Legnano - ASST Ovest Milanese
Legnano, MI, Italy, 20162
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, MI, Italy, 20122
Ospedale San Carlo Borromeo - ASST Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Milano, MI, Italy, 20157
Ospedale Città di Sesto San Giovanni - ASST Nord Milano
Sesto San Giovanni, MI, Italy, 20099
Ospedale di Polistena "Santa Maria degli Ungheresi" - ASP di Reggio Calabria
Polistena, RC, Italy, 89024
A.O.U. Policlinico Umberto I
Roma, RM, Italy, 00161
P.O. di Busto Arsizio - ASST Valle Olona
Busto Arsizio, VA, Italy, 21051
Az. Osp. Univ. dell'Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, Italy, 80138
Sponsors and Collaborators
NTC srl
Investigators
Layout table for investigator information
Principal Investigator: Gian Luigi Marseglia, Prof. Policlinico San Matteo Pavia Fondazione IRCCS
  Study Documents (Full-Text)

Documents provided by NTC srl:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: NTC srl
ClinicalTrials.gov Identifier: NCT03365648     History of Changes
Other Study ID Numbers: LER 02-2017
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Histamine Antagonists
Histamine H1 Antagonists
Histamine Agents
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs