トリート中のDESloratadine / PREDnisoloneの固定用量の組み合わせ。小児の中等度から重度のアレルギー性鼻炎 (DESPRED)
治療中のデスロラタジン 0.5 mg/mL およびプレドニゾロン 4 mg/mL 対デスロラタジン 0.5 mg/mL の FDC の優位性に関する多施設無作為化並行二重盲検比較研究。小児における持続性アレルギー性鼻炎の発生
Multicenter, randomized, parallel-group, double-blind, double-dummy, comparative clinical trial of the superiority of the fixed-dose combination of desloratadine 0.5 mg/mL and prednisolone 4 mg/mL from Eurofarma Laboratórios SA versus desloratadine 0.5 mg/mL in the treatment of moderate to severe persistent allergic rhinitis in children aged 6 to 12 years.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
調査の概要
詳細な説明
Desloratadine and prednisolone are active pharmaceutical ingredients (APIs) already registered in the country as monodrugs. These products are widely used and their efficacy and safety are well known in daily clinical practice in the approved indications.
Once confirmed the absence of pharmacokinetic interaction between desloratadine and prednisolone in relative bioavailability studies, this phase 3 study will be conducted with the objective of demonstrating the superiority of the new FDC containing desloratadine and prednisolone over the isolated administration of desloratadine in treatment from moderate to severe allergic rhinitis in children. The aim is to provide a new effective, safe and well-tolerated therapeutic option for dealing with these cases.
Multicenter, randomized, parallel group, double blind, double-dummy, superiority comparative clinical trial.
Children aged ≥ 6 years and < 12 years with moderate to severe persistent allergic rhinitis unresponsive to optimal treatment, including daily use of intranasal corticosteroids, will be randomized in a 1:1 ratio to receive FDC desloratadine 0.5mg/mL/prednisolone 4mg/mL - gel for oral administration by Eurofarma Laboratórios SA (experimental drug) or desloratadine 0.5mg/mL - syrup, for five (05) days.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
-
São Paulo、ブラジル
- Eurofarma Laboratorios S.A
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age ≥ 6 years and ≤ 12 years.
- Diagnosis of moderate to severe persistent allergic rhinitis (PAR) according to ARIA (Allergic Rhinitis and Its Impact on Asthma) criteria.
- Sensitization to aeroallergens confirmed by the presence of a positive result on the immediate skin test (PRICK test) and/or by the presence of specific IgE.
- Total nasal symptom score (TNSS ) ≥ 8 points.
- Symptom intensity score "nasal obstruction" ≥ 2 points.
- Signing of the Informed Consent Form (ICF) by the legal guardian and the Informed Assent Form (IAF) before performing any study procedure.
Exclusion Criteria:
- Being using or having an indication for antibiotic therapy upon selection for the study.
- Use of prednisolone or other oral corticosteroids in the last seven (07) days.
- Presence of uncontrolled asthma.
- Covid-19 diagnosis within four (04) weeks prior to randomization.
- Positive for SARS-COV-2 rapid antigen test at the time of randomization.
- Known allergy to desloratadine, prednisolone or any component of the product formulations under investigation.
- Presence of systemic fungal infections or uncontrolled infections.
- Presence of any serious or uncontrolled diseases, at the investigator's discretion.
- Presence of pregnancy or lactation.
- At the discretion of the investigator, female participants who are already of childbearing age must confirm the use of contraception or expressly declare that they are not at risk of pregnancy because they do not engage in sexual practices or do so in a non-reproductive manner.
- Participation in a clinical research protocol in the last 6 months, unless, according to the investigator's criteria, their participation in the study could imply a direct benefit for the participant.
- Presence of any condition that, at the investigator's discretion, renders the patient unfit to participate in the study.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Experimental drug (Desloratadine 0.5 mg/mL/Prednisolone 4 mg/mL)
ADF Group 1 - Eurofarma drug association of Desloratadine 0.5 mg/mL / Prednisolone 4 mg/mL |
FDC desloratadine 0.5 mg/mL/prednisolone 4 mg/mL from Eurofarma Laboratórios SA |
|
アクティブコンパレータ：Active Comparator: Desalex® (Desloratadine 0.5 mg/mL)
Desalex® Group 2 - Eurofarma drug Desloratadine 0.5 mg/mL |
Desloratadine 0.5 mg/mL (Desalex® - Eurofarma Laboratórios SA) |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The total nasal symptom score (TNSS)
時間枠：five (05) days after the treatment start
|
Primary objective: Demonstrate the superiority of the experimental drug (FDC desloratadine 0.5 mg/mL/prednisolone 4 mg/mL from Eurofarma Laboratórios SA) compared to desloratadine 0.5 mg/mL in alleviating symptoms of moderate/severe allergic rhinitis in children through the absolute variation of the total nasal symptom score (TNSS) five (05) days after the treatment start. The TNSS is determined by the sum of the intensity scores attributed to the symptoms of nasal obstruction, runny nose, nasal itching and sneezing in the last 24 hours. Each symptom is assessed using a 4-point categorical scale (0=absent symptom, 1=mild symptom, 2=moderate symptom, 3=intense symptom). |
five (05) days after the treatment start
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The total nasal symptom score (TNSS) ( efficacy)
時間枠：three (03) days after the treatment start
|
Secondary objectives: To compare the efficacy of the experimental drug (FDC desloratadine 0.5 mg/mL/prednisolone 4 mg/mL from Eurofarma Laboratórios SA) against desloratadine 0.5 mg/mL in alleviating symptoms of moderate/severe allergic rhinitis in children through TNSS. The TNSS is determined by the sum of the intensity scores attributed to the symptoms of nasal obstruction, runny nose, nasal itching and sneezing in the last 24 hours. Each symptom is assessed using a 4-point categorical scale (0=absent symptom, 1=mild symptom, 2=moderate symptom, 3=intense symptom). |
three (03) days after the treatment start
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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