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.
Ability to confirm voluntary participation and agreement with all study objectives by signing and dating the Informed Assent Form (IAF), with the participant's parent(s) or legal guardian(s) signing the Informed Consent Form (ICF);
Age ≥ 6 years and < 12 years on the date the IAF is signed and the ICF is signed by the parent(s) or legal guardian(s);
Diagnosis of persistent allergic rhinitis (PAR) according to the Allergic Rhinitis and its Impact on Asthma (ARIA) criteria, with severe exacerbation;
Evidence of sensitization to aeroallergens confirmed by a positive skin prick test and/or the presence of specific serum IgE;
Use of prednisolone or any other oral or parenteral corticosteroid within 7 days before enrollment;
Use of topical or oral decongestants within 3 days before randomization;
Participants receiving allergen immunotherapy;
Participants with documented clinical evidence of significant acute or chronic sinusitis, in the opinion of the investigator, at the screening visit;
Parallel
DEP114
DrugThe participants must take 5 mL per day
Desloratadine
DrugThe 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.
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).
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.
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.
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.
This trial is not recruiting at the moment. You can still explore other options:
