Exacerbations in Severe Asthma Patients: Mechanisms and Biomarkers
調査の概要
詳細な説明
Patients will be recruited from the Severe Asthma Clinics at Royal Brompton Hospital. At the first visit the investigators will enrol and characterise patients. This will involve asking patients to keep a diary record of PEFR(Peak Expiratory Flow Rate), spirometry, symptom scores, use of beta-agonist reliever and other treatments for 2 weeks. Bloods tests will be taken for markers of systemic inflammation. Markers of oxidative stress will be measured in blood, exhaled breath condensate (EBC) and urine: malondialdehyde (MDA) and 8-isoprostanes. Nitric oxide (NO) levels in exhaled breath will be measured measured twice daily for 2 weeks using a portable hand-held NO meter. If spontaneous sputum is not available, sputum will be induced using ultrasonic nebulization of isotonic saline. Profile of inflammatory cells, cytokines in supernatants, bacteriological culture and microbiome analysis will be measured in the sputum. Patients will be observed over 12 months during which time the number of exacerbations will be recorded on basis of objective measures with evaluation of ACQ (Asthma Control Questionnaire), daily morning and evening PEF (Peak Expiratory Flow). At the earliest onset of exacerbation, the patient will be requested to contact the Asthma Research Unit. Patients will then be asked to attend the laboratory where similar tests to the first visit will be performed. For other exacerbations not studied, the patient will be asked to keep a detailed diary record of symptoms with severity scoring and spirometric and PEF measurements (Exacerbation Diary) over a period of 2 weeks after onset of exacerbation.
As patients with severe asthma are usually very well experienced in what the symptoms of exacerbations are, they will therefore be asked to recognise their own exacerbations. Each patient has their own way of recognising an exacerbation and the investigators will discuss this with each patient and try and establish whether an earlier warning signal is possible. Patients will be asked to record their symptoms and lung function as soon as they feel the onset of an exacerbation, since exacerbations are recognised by the patient as events that are 'clinically identified by being outside the patient's usual range of day-to-day variation'. The patient will receive or administer treatments for the exacerbation as usual without interference from the Research Team except for starting any antibiotic therapies, which will be started (if prescribed) as soon as the visit studies have been completed. Those who have been hospitalized will not be studied, and only those who can attend the Clinical Research Unit will be studied.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
London、イギリス、SW3 6NP
- Biomedical research Unit, Royal Brompton Hospital, Sydney Street
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-
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:
All patients must be able to give informed consent. The definition of severe asthma will be on the basis of
Uncontrolled asthma: three or more of the following features present in any week in the previous 4 weeks:
- Daytime symptoms more than twice per week
- Any limitation of activities
- Nocturnal symptoms once or more per week
- Need for reliever treatment more than twice per week
- Pre bronchodilator FEV1 <80% predicted or personal best OR
- Frequent severe exacerbations (≥2 per year) OR
- Require prescription of daily or alternate day oral corticosteroids (OCS) to achieve asthma control despite the prescription of high dose inhaled corticosteroids (>1000mcg fluticasone propionate daily or equivalent) or maintenance oral corticosteroids plus a long acting beta agonist or one other controller medication (for example anti-cholinergics, leukotriene receptor antagonists or theophylline).
Exclusion Criteria:
• Current smoker, or Ex-smoker with a >10 year pack history or having smoked within the past 6 months
- Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the major problem rather than in addition to severe asthma)
- Significant other primary pulmonary disorders in particular pulmonary embolism, pulmonary hypertension, interstitial lung disease and lung cancer
- Subjects with emphysema and bronchiectasis should only be excluded if this is thought to be the major pulmonary disorder rather than in addition to severe asthma
- Diagnosis or current investigation of occupational asthma
- Any subjects currently participating, or having participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs.
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:診断
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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 |
|---|---|
|
他の:Severe Asthma
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
|
Participants have FEV1 test
|
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 |
|---|---|---|
|
Percent Predicted FEV1
時間枠:Baseline Visit, 12 months
|
From date of screening visit until date of first asthma exacerbation visit Percent predicted Forced Expiratory Volume in First Second
|
Baseline Visit, 12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Exhaled Breath Condensate
時間枠:Baseline Visit, 12 months
|
pH and free Iron
|
Baseline Visit, 12 months
|
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Markers of Oxidative Stress in Urine
時間枠:Baseline Visit, 12 months
|
malondialdehyde (MDA)
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Baseline Visit, 12 months
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Markers of Oxidative Stress in Urine
時間枠:Baseline Visit, 12 months
|
8-isoprostanes
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Baseline Visit, 12 months
|
|
Sputum Analysis
時間枠:From baseline visit and 12 months
|
Eosinophils as percentage of total count
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From baseline visit and 12 months
|
|
PCR for Respiratory Viruses
時間枠:Baseline Visit, 12 months
|
nasopharyngeal swabs
|
Baseline Visit, 12 months
|
|
Sputum Microbiome
時間枠:Baseline Visit, 12 months
|
Baseline Visit, 12 months
|
|
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Corticosteroid Insensitivity in Peripheral Blood Mononuclear Cells
時間枠:Baseline Visit, 12 months
|
Baseline Visit, 12 months
|
|
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Exhaled Nitric Oxide
時間枠:Baseline Visit, 12 months
|
Baseline Visit, 12 months
|
|
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Exhaled Hydrogen Sulphide
時間枠:Baseline Visit, 12 months
|
Baseline Visit, 12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Kian F Chung, MBBS MD FRCP、Imperial College London
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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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