Status:
COMPLETED
Efficacy and Safety of Lertal® as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics
Lead Sponsor:
NTC srl
Conditions:
Allergic Rhinoconjunctivitis
Eligibility:
All Genders
6-12 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2018
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03365648
Start Date
September 15 2017
End Date
November 13 2018
Last Update
November 15 2018
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Fondazione IRCCS Policlinico San Matteo
Pavia, (PV), Italy, 27100
2
Ospedale regionale San Salvatore - ASL 1 Avezzano Sulmona L'Aquila
L’Aquila, AQ, Italy, 67100
3
A.O.U. Consorziale "Policlinico Giovanni XXIII"
Bari, BA, Italy, 70126
4
A.O.U. Consorziale "Policlinico-Giovanni XXIII"
Bari, BA, Italy, 70126