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

Официальное название

Phase III, Multicenter, Double-blind, Planned, Parallel Clinical Trial 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

Обзор

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.

Подробное описание

* 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.

Вмешательства

• Препарат DEP114
  DEP114 oral solution
• Препарат Desloratadine 0.5 MG/ML
  Desloratadine oral solution

Первичные конечные точки

• 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. [Срок оценки: 5 days]

Вторичные конечные точки (7)

• To evaluate the effectiveness of DEP114 in relieving nasal symptoms of moderate to severe persistent allergic rhinitis in children, throughout the treatment. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 3 and 5 day]
• Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the perception of the person responsible for the participant. [Срок оценки: 5 day]
• Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the investigator's perception. [Срок оценки: 5 day]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06272409 · DEP114-III-0123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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