The goal of this clinical trial is to learn whether DEP114 is effective in treating acute exacerbations of persistent allergic rhinitis in children aged 6 to less than 12 years. The study will also evaluate the safety of DEP114. Participants will: * Take DEP114 or desloratadine once daily for 5 days (up to a maximum of 7 days). * Keep a diary of their symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
316
The participants must take 5 mL per day
The participants must take 5 mL per day
Absolute change in the Total Nasal Symptom Score (TNSS) for nasal congestion, rhinorrhea, nasal itching, and sneezing, measured 5 days after treatment initiation (TNSS₀-₅).
The Total Nasal Symptom Score (TNSS) is the sum of the severity scores for each nasal symptom assessed (nasal congestion, rhinorrhea, nasal itching, and sneezing) over the previous 24 hours. The severity of each symptom is evaluated using a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The total score ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms and a worse clinical condition. Negative changes from baseline indicate improvement in symptoms.
Time frame: Day 5 after treatment initiation
Overall improvement of nasal symptoms throughout the treatment period.
Absolute change in the Total Nasal Symptom Score (TNSS) on treatment Days 1, 2, 3, 4, and 5 (TNSS₀-₁, TNSS₀-₂, ..., TNSS₀-₅).
Time frame: Day 5 after treatment initiation
Overall improvement of nasal symptoms 3 days after treatment initiation.
Proportion of participants with improvement in the Total Nasal Symptom Score (TNSS) at Day 3 after treatment initiation, where improvement is defined as a reduction of at least 4 points from baseline. TNSS ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms and a worse clinical condition; therefore, a decrease in TNSS represents clinical improvement.
Time frame: Day 3 after treatment initiation
Change From Baseline in Nasal Congestion Severity Assessed by the Nasal Congestion Severity Score (NCSS) Throughout the Treatment Period
Absolute change from baseline in the Nasal Congestion Severity Score (NCSS) on treatment Days 1, 2, 3, 4, and 5. NCSS ranges from 0 to 3 points, where higher scores indicate more severe nasal congestion and a worse clinical condition. Negative changes from baseline indicate improvement.
Time frame: From treatment initiation through Day 5 of treatment
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Distribution of Participants by Rhinorrhea Severity Category Using the TNSS Rhinorrhea Item at Days 3 and 5
Distribution of participants according to rhinorrhea severity categories based on the rhinorrhea item of the Total Nasal Symptom Score (TNSS), assessed at Days 3 and 5 after treatment initiation.
Time frame: 3 and 5 days after treatment initiation
Improvement in Nasal Itching Severity Assessed by the Total Nasal Symptom Score (TNSS) at Days 3 and 5 After Treatment Initiation
Distribution of participants according to nasal itching severity assessed using the nasal itching item of the Total Nasal Symptom Score (TNSS) at Days 3 and 5 after treatment initiation.
Time frame: Day 3 and Day 5 after treatment initiation
Improvement in Sneezing Severity Assessed by the Total Nasal Symptom Score (TNSS) at Days 3 and 5 After Treatment Initiation
Distribution of participants according to sneezing severity assessed using the sneezing item of the Total Nasal Symptom Score (TNSS) at Days 3 and 5 after treatment initiation.
Time frame: Day 3 and Day 5 after treatment initiation
Global Assessment of Treatment by the Participant's Caregiver at Day 5 After Treatment Initiation
Distribution of participants according to the categories of the caregiver's global assessment of treatment scale: 0 = very poor, 1 = poor, 2 = neither good nor poor, 3 = good, and 4 = very good.
Time frame: Day 5 after treatment initiation
Investigator Global Assessment of Treatment at Day 5
Distribution of participants according to the investigator's global assessment of treatment score categories (0 = very poor, 1 = poor, 2 = neither good nor poor, 3 = good, and 4 = very good).
Time frame: Day 5 after treatment initiation