Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children.

NCT ID: NCT06272409

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2027-04-15

Brief Summary

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.

Detailed Description

• double-blind, superiority, parallel group trial.
• Experiment duration: 05 days.
• 03 visits (days 0, 5 and 28).
• Efficacy will be evaluated for persistent allergic rhinitis based on Global improvement in nasal symptoms score
• Adverse events evaluation.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DEP114

DEP114 administered once (01) time a day, by morning, for 5 (+2) days.

Group Type: EXPERIMENTAL

DEP114

Intervention Type: DRUG

DEP114 oral solution

DESLORATADINE

Desloratadine administered once (01) time a day, by morning, for 5 (+2) days.

Group Type: ACTIVE_COMPARATOR

Desloratadine 0.5 MG/ML

Intervention Type: DRUG

Desloratadine oral solution

Interventions

DEP114

DEP114 oral solution

Intervention Type: DRUG

Desloratadine 0.5 MG/ML

Desloratadine oral solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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);
• Symptom intensity score "nasal obstruction" ≥ 2 points.
• Total nasal symptoms score (TNSS) ≥ 8 points.

Exclusion Criteria

• 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;
• Diagnosis of severe or uncontrolled asthma;
• Allergy to desloratadine, prednisolone or any other component of the formulation of investigational products (PSIs);
• Presence of systemic fungal infection;
• Presence of any uncontrolled infection;
• Presence of any clinical observation finding (evaluation clinical/physical) or laboratory condition that is interpreted by the investigator physician as a risk to participation in the trial clinical or presence of serious uncontrolled disease(s);
• Participants who are pregnant or breastfeeding;
• Participation in clinical trial protocols in the last 12 (twelve) months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator believes that there may be direct benefit to the participant.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DEP114-III-0123

Identifier Type: -

Identifier Source: org_study_id