Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma
調査の概要
状態
条件
詳細な説明
Neutrophils are implicated in the pathophysiology of multiple asthma phenotypes. It was shown in study IST Q4935s that low-density granulocytes (LDG) are elevated in the blood of patients with moderate or severe asthma. The greatest frequency and the highest percentages of LDG were observed in subjects with severe asthma. The LDG, which were first identified and characterized in systemic lupus erythematosus (SLE) patients, have been reported to display increased cytotoxicity for endothelial cells, increased tendency to form neutrophil extracellular traps, and increased production of tumor necrosis factor (TNF). It was also observed that the LDG expressed increased levels of CD15, which can facilitate attachment of activated platelets to the LDG. Identification of a putative serum biomarker that correlates with increased levels of the CD15+ LDG may be useful for the detection of neutrophil-associated inflammation in severe asthma.
Thirty subjects will be screened to identify 20 subjects with severe persistent asthma. The following data and/or samples will then be obtained within three weeks of the clinical assessment: (1) the percentages of LDG will be quantified by flow cytometry; (2) a blood sample will be collected into a PAXgene Blood tube and stored until shipped to Genentech for gene profiling analysis; and (3) a serum sample will be collected for measurement of total immunoglobulin E (IgE) and for future confirmation of potential biomarkers identified in the gene profiling analyses.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Illinois
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Chicago、Illinois、アメリカ、60612
- University Consultants in Allergy/Immunology
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Physician diagnosis of severe persistent asthma;
- Positive skin test or radioallergosorbent test (RAST) for an aeroallergen;
- Male or female age 12-65 years;
- Non-smoker.
Exclusion Criteria:
- Asthma exacerbation requiring treatment with or increase in oral corticosteroids within 30 days prior to the study;
- Respiratory infection within 30 days prior to the study;
- Starting or requiring a change in allergen immunotherapy within 30 days prior to the study;
- Having been treated with Xolair within the past year;
- Requiring chronic immunosuppressive therapy;
- Having taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics within 3 months prior to study;
- Having taken an investigational drug within 30 days prior to the study;
- Have a history of drug or alcohol abuse;
- Pregnancy
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
コホートと介入
グループ/コホート |
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Severe Persistent Asthma
All subjects will have severe persistent asthma diagnosed by a doctor.
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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 |
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Percentage of low density granulocytes (LDG) in the peripheral blood mononuclear cell (PBMC)
時間枠：Visit 1 day
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Visit 1 day
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mRNA levels in severe asthmatics as analyzed by gene profiling analysis
時間枠：Visit 1 day
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Messenger ribonucleic acid (mRNA) expression levels for blood leukocyte proteins.
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Visit 1 day
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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 |
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Number of Participants with elevated LDG levels in severe asthmatics using gene profiling analysis on a single PAXgene tube sample
時間枠：Visit 1 day
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Visit 1 day
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Serum samples will be collected and analyzed for measurement of total IgE
時間枠：Visit 1 day
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Correlation between LDG in severe asthma and biomarkers identified in gene profiling analysis
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Visit 1 day
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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 (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
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。