小児喘息の診断と治療の進歩 (Care4Asthma)
小児喘息の診断と治療の進歩：深層免疫表現型解析と吸入コルチコステロイド投与用スペーサー装置2種の評価
Asthma is one of the most common chronic diseases in children, and treatment success often depends on proper inhaler use and consistent medication adherence. Exposure to allergens and pollutants can also impact treatment response and asthma control. Moreover, there is a growing need for non-invasive biomarkers to support better diagnosis and personalized care. The goal of this clinical trial is to investigate if a new digital inhaler can improve inhalation technique and treatment adherence in children aged 5 to 16 years old, with partly controlled or uncontrolled asthma requiring treatment with inhaled corticosteroids. The main questions it aims to answer are:
- Does the use of a digital inhaler improve adherence to inhaled corticosteroids and asthma control in children?
- Which biomarkers could support diagnosis and help predict treatment responses in children with asthma?
- How do environmental factors influence asthma control and treatment outcomes?
Researchers will compare adherence to inhaled corticosteroid therapy between children using a new digital inhaler (Whizz spacer) and those using a standard, non-digital inhaler (AeroChamber Plus® Flow-Vu®) to see if the digital inhaler improves treatment administration and asthma control. They will quantify inflammatory markers in biological samples from asthmatic children and children without respiratory disease, to find biomarkers linked to disease and treatment response.
Participants will:
- Use the Whizz spacer or the AeroChamber Plus® Flow-Vu® during 12 weeks for corticosteroid inhalation, and complete daily a study diary to follow treatment administration.
- Complete asthma control and quality of life questionnaires and have an evaluation of asthma control through GINA score at baseline, 6 and 12 weeks.
- Undergo spirometry tests and FENO measurements at baseline and 12 weeks.
- Give biological samples at baseline and 12 weeks.
- Collect children's bedroom dust samples at baseline.
- Wear a bracelet for 7 days at baseline and 12 weeks to monitor physical activity.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Christiane Hilger, PhD
- 電話番号：+352 26970258
- メール：christiane.hilger@lih.lu
研究連絡先のバックアップ
- 名前：Ali Znati
- 電話番号：+352 26970-811
- メール：ALi.Znati@lih.lu
研究場所
-
-
-
Liège、ベルギー、4000
- 募集
- CHC Mont Légia
-
コンタクト：
- Matthieu Thimmesch, M.D.
- 電話番号：+32 04 355 50 20
- メール：matthieu.thimmesch@chc.be
-
-
-
-
-
Luxembourg、ルクセンブルク
- 募集
- Luxembourg Research Clinic (LRC)
-
主任研究者：
- Anna-Maria Charatsi, MD
-
コンタクト：
- Ali Znati
- 電話番号：+352 26970-811
- メール：ALi.Znati@lih.lu
-
-
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:
- Patient aged between 5-16 years, male or female
- Physician diagnosis of asthma requiring a controller treatment with ICS or ICS/Long-acting beta-agonists (LABA) via MDI
- Partly controlled or uncontrolled asthma based on GINA criteria and definitions
- Informed consent signed by legally authorized representatives (LAR) and assent from young patient (only applicable for children ≥ 10 years)
Exclusion Criteria:
- Patients with severe asthma exacerbation treated with systemic corticosteroids within the last 2 weeks or patients with active respiratory tract infection
- Diagnosis of underlying chronic lung disease other than asthma (e.g., BPCO/cystic fibrosis etc.)
- Severe asthma based on GINA definitions
- Severe underlying disorders ((severe congenital heart disease, oncologic patients) (non-exhaustive list, left to the evaluation of the PI))
- Immune deficiency or under immunosuppressive treatments
- In receipt of immunotherapy (only for participants in Luxembourg donating samples for biomarker research)
- Patients with neurological diseases / impaired cognitive disorder
- Siblings of patients already included 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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Inhaled corticosteroid administration in asthmatic children using AeroChamber Plus® Flow-Vu®
Asthmatic children use AeroChamber Plus® Flow-Vu® to inhale their corticosteroid containing medication for 12 weeks. This inhaler is standard and does not have light indicators to monitor treatment administration. |
AeroChamber Plus® Flow-Vu® is a standard valved holding chamber used to administer aerosolized medication from the metered dose inhaler to the patient. |
|
実験的：Inhaled corticosteroid administration in asthmatic children using the Whizz spacer.
Asthmatic children use Whizz spacer to inhale their corticosteroid containing medication for 12 weeks. This inhaler has inhalation flow rate monitor with light indicators and is linked to a mobile application, to monitor treatment adherence and administration. |
Whizz spacer is a new digital valved holding chamber that is intended to administer aerosolized medication from the metered dose inhaler to the patient. It allows monitoring of treatment administration through light indicators and a mobile application. |
|
介入なし：Non-asthmatic children
Non-asthmatic children, male or female, aged 5-16 years old, who have a blood test foreseen in their medical routine follow up for a non-respiratory disease, are recruited for a single visit at baseline. |
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 |
|---|---|---|
|
Measurement of inhaled corticosteroid therapy adherence and comparison between the two spacers
時間枠：From enrolment to the end of the intervention at 12 weeks
|
Adherence rate will be measured by the entries in the study booklet as well as weighing the medication canisters at baseline, 6 weeks and at 12 weeks. Researchers expect to determine if light indicators and digital reminders on the Whizz spacer led to increased adherence to treatment and thus to a better clinical outcome in asthmatic children, as compared to a standard spacer. |
From enrolment to the end of the intervention at 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assessment of asthma control
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Asthma control will be assessed by clinical evaluation, objective lung function tests and patient questionnaires. Researchers want to compare asthma control in children using the Whizz spacer and the standard spacer. |
At baseline and at the end of the intervention (12 weeks)
|
|
Quantification of inflammatory markers and deep immunophenotyping of circulating immune cells to identify non-invasive biomarkers and immune signatures
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Inflammatory markers will be quantified in biological samples obtained from asthmatic children. Researchers expect to determine biomarkers and immune signatures associated with response to inhaled corticosteroid treatment and to different asthma endotypes. These biomarkers could be used for asthma diagnosis and to predict treatment response and asthma exacerbation. |
At baseline and at the end of the intervention (12 weeks)
|
|
Assessment of patients' environmental exposure
時間枠：At baseline
|
Allergens will be analyzed in the dust collected during 2 weeks in the children's bedroom and pollutants will be identified in the children's hair. Researchers want to describe factors of environmental exposure which are linked to a poor response to treatment, immune imbalance and risk of asthma exacerbations. |
At baseline
|
|
Monitoring physical activity using accelerometer bracelet
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Physical activity will be monitored for one week, at baseline and at the end of the intervention, using an accelerometer bracelet. Researchers expect to follow the evolution of physical activity, as better asthma control will most likely translate into more physical activity. |
At baseline and at the end of the intervention (12 weeks)
|
協力者と研究者
協力者
捜査官
- 主任研究者：Christiane Hilger, PhD、Luxembourg Institute of Health
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。