Clinical trial NCT03365648: Efficacy and Safety of Lertal® as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinoconjunctivitis
Lead sponsor: NTC srl
Sponsor class: INDUSTRY
First posted: 2017-12-07
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blinded, parallel-group, placebo-controlled clinical study
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Total Symptom Score (TSS) scores
timeFrame: At Baseline and after Visit 4 (Week 4)
Secondary outcomes:
measure: Visual Analogue Scale (VAS) score
timeFrame: At Baseline, after Visit 3 (Week 2) and after Visit 4 (Week 4)
measure: Total Symptom Score (TSS) scores
timeFrame: At Baseline and after Visit 3 (Week 2)
measure: Number of responders (30% reduction of TSS)
timeFrame: After Visit 3 (Week 2) and after Visit 4 (Week 4)
measure: Time to maximum effect on Total Symptom Score (TSS) vs placebo
timeFrame: From baseline to Visit 6 (Week 16)
measure: Number of patients using rescue treatment
timeFrame: From baseline to Visit 6 (Week 16)
measure: Total Nasal Symptom Score (TNSS)
timeFrame: At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4)
measure: Total Ocular Symptom Score (TOSS)
timeFrame: At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4)
measure: Total Throat Symptom Score (TTSS)
timeFrame: At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4)
measure: Number of patients symptom-free or with mild symptoms
timeFrame: From V3 (Week 2) to Visit 4 (Week 4)
measure: Number of exacerbations
timeFrame: From Visit 5 (Week 8) to Visit 6 (Week 16)
measure: Intensity (mild, moderate, severe) of exacerbations
timeFrame: From Visit 5 (Week 8) to Visit 6 (Week 16)
measure: Duration (number of days) of exacerbations
timeFrame: From Visit 5 (Week 8) to Visit 6 (Week 16)
Other outcomes:
measure: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) recorded throughout the study
timeFrame: From baseline to Visit 6 (Week 16)
measure: Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) total score
timeFrame: At Baseline, at Visit 4 (Week 4) and at Visit 5 (Week 8) or Visit 6 (Week 16)
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
state: (pv)
city: L'Aquila
country: Italy
facility: Ospedale regionale San Salvatore - ASL 1 Avezzano Sulmona L'Aquila
state: AQ
city: Bari
country: Italy
facility: A.O.U. Consorziale "Policlinico Giovanni XXIII"
state: BA
city: Bari
country: Italy
facility: A.O.U. Consorziale "Policlinico-Giovanni XXIII"
state: BA
city: Catania
country: Italy
facility: A.O.U. Policlinico Vittorio Emanuele
state: CT
city: Genova
country: Italy
facility: Istituto Giannina Gaslini
state: GE
city: Crotone
country: Italy
facility: P.O. San Giovanni di Dio - ASP di Crotone
state: KR
city: Messina
country: Italy
facility: A.O.U. Policlinico "G. Martino"
state: ME
city: Garbagnate Milanese
country: Italy
facility: P.O. G. Salvini di Garbagnate Milanese - ASST Rhodense
state: MI
city: Legnano
country: Italy
facility: Ospedale Civile di Legnano - ASST Ovest Milanese
state: MI
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: MI
city: Milano
country: Italy
facility: Ospedale San Carlo Borromeo - ASST Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
state: MI
city: Sesto San Giovanni
country: Italy
facility: Ospedale Città di Sesto San Giovanni - ASST Nord Milano
state: MI
city: Polistena
country: Italy
facility: Ospedale di Polistena "Santa Maria degli Ungheresi" - ASP di Reggio Calabria
state: RC
city: Roma
country: Italy
facility: A.O.U. Policlinico Umberto I
state: RM
city: Busto Arsizio
country: Italy
facility: P.O. di Busto Arsizio - ASST Valle Olona
state: VA
city: Napoli
country: Italy
facility: Az. Osp. Univ. dell'Università degli Studi della Campania "Luigi Vanvitelli"
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Gian Luigi Marseglia, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.