Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists (eXplore)
2012年12月12日 更新者：Novartis Pharmaceuticals
A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Trial to Explore the Effects of 78 Weeks Omalizumab Treatment Given as Add on Therapy on Markers of Airway Inflammation and Remodeling in Patients With Moderate to Severe Persistent Allergic Asthma Receiving Inhaled Corticosteroids and Long Acting Beta-agonists
This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists.
This study will also investigate the correlation between systemic and pulmonary inflammation, and the correlation between clinical outcomes and changes within the tissue, to assist in the future identification of patients with tissue eosinophilia and their response to treatment, without the need for invasive bronchoscopy.
調査の概要
研究の種類
介入
入学 (実際)
36
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Colorado
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Denver、Colorado、アメリカ、80206
- Novartis Investigative Site
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Missouri
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St. Louis、Missouri、アメリカ、63110
- Novartis Investigative Site
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North Carolina
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Durham、North Carolina、アメリカ、27710
- Novartis Investigative Site
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Novartis Investigative Site
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Philadelphia、Pennsylvania、アメリカ、19140
- Novartis Investigative Site
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Texas
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Galveston、Texas、アメリカ、77555-1083
- Novartis Investigative Site
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Glasgow - Scotland、イギリス、G12 OYN
- Novartis Investigative Site
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Manchester、イギリス、M20 8LR
- Novartis Investigative Site
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Southampton、イギリス、SO16 6YD
- Novartis Investigative Site
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Leiden 2333 ZA、オランダ、2333
- Novartis Investigative Site
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Quebec、カナダ、G1V 4G5
- Novartis Investigative Site
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Alberta
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Calgary、Alberta、カナダ、T2N 4N1
- Novartis Investigative Site
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Quebec
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Montreal、Quebec、カナダ、H2X 2P4
- Novartis Investigative Site
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Lund、スウェーデン、SE-221 85
- Novartis Investigative Site
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Mainz、ドイツ、D-55101
- Novartis Investigative Site
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Montpellier、フランス、34059
- Novartis Investigative Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients 18-75 years of age with moderate to severe persistent allergic asthma receiving a high dose inhaled corticosteroid (≥800µg per day BDP or equivalent) and a regular long acting beta-agonist for at least 3 months prior to screening
- With a body weight between 20 and 150kg and a serum total IgE level of 30 to 700 IU/mL
- With ≥2% eosinophilia in induced sputum at screening
- With post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥60% predicted
- With a positive skin prick test (diameter of wheal ≥ 3 mm) or RAST test to at least one perennial aero-allergen (eg. dust mite, cat/dog dander, cockroaches), documented within the past 2 years or demonstrated at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
Exclusion Criteria:
- Patients who've had an asthma exacerbation during the 4 weeks prior to randomization
- Current smokers, stopped smoking within the last 12 months or have a smoking history of >10 pack years
- History of severe allergy to food or drugs
- Previous treatment with omalizumab
- Any patient considered to be unsuitable to bronchoscopy, according to the judgment of the investigator
Other protocol-defined inclusion/exclusion criteria applied.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：omalizumab
Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection.
The dose administered was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables.
Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
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プラセボコンパレーター：Placebo
Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection.
The number of injections and injection volume was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables.
Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
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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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Change From Baseline in Total Subepithelial Eosinophils at the End of Week 78 (End of Treatment)
時間枠：Baseline, at end of week 78
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The primary variable of change from baseline in total epithelia eosinophils at end of Week 78 was analyzed on sub-population such as responders and non-responders.
Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening.
GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
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Baseline, at end of week 78
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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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Change From Baseline in Sub-epithelial Cell Count of Mast Cells Following 78 Weeks Treatment, as Assessed Biopsy Samples
時間枠：Baseline, at end of week 78
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The variable of change from baseline in Sub-epithelial cell count of mast cells at end of Week 78 was analyzed on sub-population such as responders and non-responders.
Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening.
GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
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Baseline, at end of week 78
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Change From Baseline in Sub-epithelial CD4+ T-lymphocytes Following 78 Weeks Treatment, as Assessed Biopsy Samples
時間枠：Baseline, at end of week 78
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The variable of change from baseline in Sub-epithelial CD4+ T-lymphocytes at end of Week 78 was analyzed on sub-population such as responders and non-responders.
Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening.
GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
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Baseline, at end of week 78
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Change From Baseline in Thickness of the Lamina Reticularis Following 78 Weeks Treatment, as Assessed Biopsy Samples
時間枠：Baseline, at end of week 78
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The variable of change from baseline in thickness of the lamina reticularis at end of Week 78 was analyzed on sub-population such as responders and non-responders.
Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening.
GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
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Baseline, at end of week 78
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Number of Participants With Adverse Events, Serious Adverse Events and Death as an Assessment of Safety and Tolerability of 78 Weeks Therapy
時間枠：78 weeks
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78 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年4月1日
一次修了 (実際)
2011年11月1日
研究の完了 (実際)
2011年11月1日
試験登録日
最初に提出
2008年4月30日
QC基準を満たした最初の提出物
2008年5月1日
最初の投稿 (見積もり)
2008年5月2日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年1月18日
QC基準を満たした最後の更新が送信されました
2012年12月12日
最終確認日
2012年11月1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。