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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
DEP114
DrugDEP114 oral solution
Desloratadine 0.5 MG/ML
DrugDesloratadine oral solution
Treatment groups
318 Participants
are divided into 2 treatment groupsGroup A: DEP114Experimental treatment 1 intervention
Group B: DESLORATADINEActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To demonstrate the superiority of DEP114 in relation to desloratadine 0.5 mg/mL in relieving the nasal symptoms of moderate to severe persistent allergic rhinitis in children, five days after starting treatment.
Global improvement in nasal symptoms (absolute variation in total nasal symptoms score obstruction, runny nose, itching and sneezing, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms) five days after the start of treatment.
Time frame
5 daysSecondary outcomes
1
To evaluate the effectiveness of DEP114 in relieving nasal symptoms of moderate to severe persistent allergic rhinitis in children, throughout the treatment.
Global improvement in nasal symptoms throughout treatment (absolute variation in the total score of nasal symptoms, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms) on days 1, 2, 3, 4 and 5. Improvement of nasal symptoms three days after the start of the treatment (proportion of participants with improvement in total nasal symptoms score, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms) three days after the start of treatment, with improvement in total nasal symptoms score change of at least 4 points on day 3 compared to at baseline).
Time frame
1-5 days2
Evaluate the efficacy of DEP114 to relieve nasal obstruction present in moderate to severe persistent allergic rhinitis in children through the treatment.
Improvement of nasal obstruction throughout treatment (absolute variation in total nasal symptoms score obstruction, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms) on days 1, 2, 3, 4 and 5.
Time frame
1-5 days3
Evaluate the efficacy of DEP114 to relieve coryza present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment.
Improvement of the runny nose three and five days after the start of the treatment (distribution of participants according to intensity of coryza at baseline, three and five days after the start of treatment).
Time frame
3 and 5 day4
Evaluate the efficacy of DEP114 to relieve nasal itching present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment.
Improvement of nasal itching three and five days after the onset treatment (distribution of participants according to intensity of nasal itching at baseline, three and five days after starting treatment).
Time frame
3 and 5 dayLocations
Source ClinicalTrials.gov
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