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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lertal® + standard therapy | Experimental | Lertal® double-layer tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine) |
|
| Placebo + standard therapy | Placebo Comparator | Placebo tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lertal® + standard therapy | Dietary Supplement | Lertal® is a novel food supplement. Each tablet contains the following active ingredients:
Standard therapy: antihistamine. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) score | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) recorded throughout the study | The incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) recorded throughout the study will be presented overall and by treatment group respectively. | From baseline to Visit 6 (Week 16) |
| Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) total score |
Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Gian Luigi Marseglia, Prof. | Fondazione IRCCS Policlinico San Matteo di Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo | Pavia | (PV) | 27100 | Italy | ||
| Ospedale regionale San Salvatore - ASL 1 Avezzano Sulmona L'Aquila |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31319883 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2017 |
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A randomized, double-blinded, parallel-group, placebo-controlled clinical study
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Double-blinded
|
| Placebo + standard therapy | Other | Placebo tablet identical in appearance, size and taste to Lertal® tablets. Standard therapy: antihistamine. Standard therapy: antihistamine |
|
| At Baseline, after Visit 3 (Week 2) and after Visit 4 (Week 4) |
| Total Symptom Score (TSS) scores | 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:
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 3 (Week 2) |
| Number of responders (30% reduction of TSS) | 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. | After Visit 3 (Week 2) and after Visit 4 (Week 4) |
| Time to maximum effect on Total Symptom Score (TSS) vs placebo | 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:
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. | From baseline to Visit 6 (Week 16) |
| Number of patients using rescue treatment | 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. | From baseline to Visit 6 (Week 16) |
| Total Nasal Symptom Score (TNSS) | 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. | At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4) |
| Total Ocular Symptom Score (TOSS) | 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. | At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4) |
| Total Throat Symptom Score (TTSS) | 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. | At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4) |
| Number of patients symptom-free or with mild symptoms | 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. | From V3 (Week 2) to Visit 4 (Week 4) |
| Number of exacerbations | Exacerbations are defined as the need of an antihistamine medication of any kind, at any dose and of any duration. | From Visit 5 (Week 8) to Visit 6 (Week 16) |
| Intensity (mild, moderate, severe) of exacerbations | Exacerbations are defined as the need of an antihistamine medication of any kind, at any dose and of any duration. | From Visit 5 (Week 8) to Visit 6 (Week 16) |
| Duration (number of days) of exacerbations | Exacerbations are defined as the need of an antihistamine medication of any kind, at any dose and of any duration. | From Visit 5 (Week 8) to 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. |
| At Baseline, at Visit 4 (Week 4) and at Visit 5 (Week 8) or Visit 6 (Week 16) |
| L’Aquila |
| AQ |
| 67100 |
| Italy |
| A.O.U. Consorziale "Policlinico Giovanni XXIII" | Bari | BA | 70126 | Italy |
| A.O.U. Consorziale "Policlinico-Giovanni XXIII" | Bari | BA | 70126 | Italy |
| A.O.U. Policlinico Vittorio Emanuele | Catania | CT | 95123 | Italy |
| Istituto Giannina Gaslini | Genova | GE | 16132 | Italy |
| P.O. San Giovanni di Dio - ASP di Crotone | Crotone | KR | 88900 | Italy |
| A.O.U. Policlinico "G. Martino" | Messina | ME | 98124 | Italy |
| P.O. G. Salvini di Garbagnate Milanese - ASST Rhodense | Garbagnate Milanese | MI | 20042 | Italy |
| Ospedale Civile di Legnano - ASST Ovest Milanese | Legnano | MI | 20162 | Italy |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | MI | 20122 | Italy |
| Ospedale San Carlo Borromeo - ASST Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo | Milan | MI | 20157 | Italy |
| Ospedale Città di Sesto San Giovanni - ASST Nord Milano | Sesto San Giovanni | MI | 20099 | Italy |
| Ospedale di Polistena "Santa Maria degli Ungheresi" - ASP di Reggio Calabria | Polistena | RC | 89024 | Italy |
| A.O.U. Policlinico Umberto I | Roma | RM | 00161 | Italy |
| P.O. di Busto Arsizio - ASST Valle Olona | Busto Arsizio | VA | 21051 | Italy |
| Az. Osp. Univ. dell'Università degli Studi della Campania "Luigi Vanvitelli" | Naples | 80138 | Italy |
| Nov 9, 2017 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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