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

NCT06272409 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: DEP114-III-0123
• Study Type: interventional
• Target: 318
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Rhinitis

Outcome Measures

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.

  5 days

Secondary Outcomes (7)

• To evaluate the effectiveness of DEP114 in relieving nasal symptoms of moderate to severe persistent allergic rhinitis in children, throughout the treatment.

  1-5 days

• Evaluate the efficacy of DEP114 to relieve nasal obstruction present in moderate to severe persistent allergic rhinitis in children through the treatment.

  1-5 days

• 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.

  3 and 5 day

• 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.

  3 and 5 day

• Evaluate the efficacy of DEP114 to relieve sneezing present in persistent allergic rhinitis moderate to severe in children, three and five days after the start of treatment.

  3 and 5 day

Study Arms (2)

DEP114

EXPERIMENTAL

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

Drug: DEP114

DESLORATADINE

ACTIVE COMPARATOR

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

Drug: Desloratadine 0.5 MG/ML

Interventions

DEP114 DRUG

DEP114 oral solution

DEP114

Desloratadine 0.5 MG/ML DRUG

Desloratadine oral solution

DESLORATADINE

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 22, 2024
• Study Start: February 15, 2025
• Primary Completion: March 15, 2025
• Study Completion (Estimated): April 15, 2027
• Last Updated: February 22, 2024

Record last verified: 2024-02