Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children.
ConditionAllergic Rhinitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-11
SponsorEMS
About this trial
The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years.
Eligibility criteria
Qualifiers
Ability to confirm voluntary participation and agree for all the purposes of the test, signing and dating the Term of Free and Informed Assent (TALE), signed by the Free and Informed Consent Form (TCLE) by responsible;
Age ≥ 6 years and ≤ 11 years on the day of signing the TALE and the TCLE by the person responsible;
Diagnosis of moderate to severe persistent allergic rhinitis (PAR) according to the criteria of Allergic Rhinitis and its Impact on Asthma (ARIA);
Presence of sensitization to aeroallergens confirmed by positive result to the immediate reading skin test (PRICK test) and/or the presence of specific IgE to the test radioallergoabsorbent (RAST);
Disqualifiers
Use of prednisolone or other oral or parenteral corticosteroid in the seven (07) days prior to inclusion;
Use of H1 antihistamine, anti-leukotriene and decongestant topic in the seven (07) days prior to inclusion;
Use or indication for the use of antibiotics at the screening visit and randomization;
Presence of adenoid hypertrophy or anatomical disorders known obstructive disorders (e.g. septal deviation) that may be held responsible for nasal obstruction, at the discretion of the investigator;
Trial design
Treatments tested in this trial
- DEP114
- Desloratadine 0.5 MG/ML
Treatment groups
318 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov