Efficacy and Safety of Lertal® as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics
- Conditions
- Allergic Rhinoconjunctivitis
- Interventions
- Dietary Supplement: Lertal® + standard therapyOther: Placebo + standard therapy
- Registration Number
- NCT03365648
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lertal® + standard therapy Lertal® + standard therapy Lertal® double-layer tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine) Placebo + standard therapy Placebo + standard therapy Placebo tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine)
- Primary Outcome Measures
Name Time Method Total Symptom Score (TSS) scores 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
Name Time Method Number of exacerbations 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.
Time to maximum effect on Total Symptom Score (TSS) vs placebo 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.Number of patients using rescue treatment 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.
Total Ocular Symptom Score (TOSS) 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.Total Throat Symptom Score (TTSS) 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.Visual Analogue Scale (VAS) score 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.
Total Nasal Symptom Score (TNSS) 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.Number of patients symptom-free or with mild symptoms 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.
Duration (number of days) of exacerbations 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.
Total Symptom Score (TSS) scores 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.Number of responders (30% reduction of TSS) 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.
Intensity (mild, moderate, severe) of exacerbations 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.
Trial Locations
- Locations (17)
Ospedale regionale San Salvatore - ASL 1 Avezzano Sulmona L'Aquila
🇮🇹L'Aquila, AQ, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, (pv), Italy
A.O.U. Consorziale "Policlinico Giovanni XXIII"
🇮🇹Bari, BA, Italy
A.O.U. Policlinico Vittorio Emanuele
🇮🇹Catania, CT, Italy
A.O.U. Consorziale "Policlinico-Giovanni XXIII"
🇮🇹Bari, BA, Italy
Istituto Giannina Gaslini
🇮🇹Genova, GE, Italy
P.O. San Giovanni di Dio - ASP di Crotone
🇮🇹Crotone, KR, Italy
A.O.U. Policlinico "G. Martino"
🇮🇹Messina, ME, Italy
P.O. G. Salvini di Garbagnate Milanese - ASST Rhodense
🇮🇹Garbagnate Milanese, MI, Italy
Ospedale Civile di Legnano - ASST Ovest Milanese
🇮🇹Legnano, MI, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milano, MI, Italy
Ospedale San Carlo Borromeo - ASST Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
🇮🇹Milano, MI, Italy
Ospedale di Polistena "Santa Maria degli Ungheresi" - ASP di Reggio Calabria
🇮🇹Polistena, RC, Italy
Ospedale Città di Sesto San Giovanni - ASST Nord Milano
🇮🇹Sesto San Giovanni, MI, Italy
A.O.U. Policlinico Umberto I
🇮🇹Roma, RM, Italy
P.O. di Busto Arsizio - ASST Valle Olona
🇮🇹Busto Arsizio, VA, Italy
Az. Osp. Univ. dell'Università degli Studi della Campania "Luigi Vanvitelli"
🇮🇹Napoli, Italy