A Study of CNTO 3157 in Healthy Normal and Asthmatic Participants Inoculated With Human Rhinovirus Type 16
2014年12月11日 更新者：Janssen Research & Development, LLC
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating CNTO 3157 in Healthy Normal and Asthmatic Subjects Inoculated With Human Rhinovirus Type 16
The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part 2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16).
調査の概要
状態
完了
詳細な説明
This is a two-part, randomized (participants are assigned to treatment by chance), double-blind (participants and investigators do not know what study agent is being administered), placebo-controlled study.
A placebo appears identical to a study agent, has no active ingredients, and helps investigators evaluate the effect of a study agent.
In Part 1, following administration of CNTO 3157 or placebo, the severity of an upper respiratory tract infection, due to inoculation with HRV 16, will be assessed in healthy participants for safety reasons.
In Part 2, following administration of CNTO 3157 or placebo and inoculation with HRV-16, efficacy and safety will be assessed in asthmatic participants using standard assessments to evaluate asthma treatments.
The study (Parts 1 and 2) will be completed when the last participant completes the last visit (Week 11) in Part 2.
研究の種類
介入
入学 (実際)
76
段階
- フェーズ 1
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。
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
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Understanding of the study and a signed informed consent form before any study-related procedures
- Willing and able to adhere to the restrictions specified in the protocol
- Results of the following laboratory tests within the following limits: serum alanine aminotransferase (ALT) levels ≤2 x ULN; serum aspartate aminotransferase (AST) levels ≤2 x ULN
- Part 1 (healthy participants):
- a). Body weight in the range of 40 to 125 kg, inclusive. Have a body mass index (BMI) of 19 to 32 kg/m2, inclusive
- b). Healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, coagulation and urinalysis, measurement of vital signs, and 12-lead electrocardiogram (ECG) performed at Screening Visit 2
- Part 2:
- a). (BMI) of 19 to 40 kg/m2, inclusive; have a physician-documented diagnosis of asthma for at least 6 months prior to Screening Visit 2; have stable asthma based on physician assessment at Screening Visit 2
- b). Have an Asthma Control Questionnaire (ACQ) symptom score less than (<)2.5 at Screening Visit 2
- c). Have a prebronchodilator forced expiratory volume in the first second (FEV1) greater than or equal to (>=) 65 percent of predicted normal value at Screening Visit 2
Exclusion Criteria:
- Part 1 (healthy participants): Has any condition that in the opinion of the investigators, would constitute a risk or a contraindication for participating in the study, prevent the participant from meeting or performing study requirements, or could interfere with the study objectives, conduct, or evaluation
- At Screening Visit 1 and throughout the study, works with (or lives with a family member who cares for) the elderly, (eg, nursing home), or lives with someone who may be at risk from transmission of the human rhinovirus type 16 (HRV-16) challenge agent, including, but not limited to, individuals with chronic lung disease (including asthma), a premature infant, or an immunocompromised individual
- Has had any acute illness, including a common cold, within 4 weeks prior to Screening Visit 1, or has had a major illness or hospitalization within 6 months prior to Screening Visit 1
- Has active allergic rhinitis or perennial allergy symptoms (eg, due to ragweed) at Screening Visit 2 or expects to have active allergic rhinitis or perennial allergy symptoms during the study
- Has a current infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized and/or received antimicrobials for a serious infection during the 6 months prior to Screening Visit 1
- Part 2 (asthmatic patients): Has a history of any other chronic lung disease, including chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease, liver or renal insufficiency; significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, or other body system disorders that are clinically significant in the opinion of the investigator
- Has ever had an episode of life-threatening asthma defined as respiratory arrest or requiring intubation for asthma
- Has been hospitalized (for greater than 24 hours) due to asthma in the 5 years prior to Screening Visit 1
- Has experienced an asthma exacerbation in the 12 weeks prior to Screening Visit 1 requiring management with systemic steroids
- Is receiving a high-dose inhaled corticosteroid (ICS) (>500 µg/day to fluticasone or equivalent). Use of low or medium dose ICS (≤500 µg/day fluticasone or equivalent) with or without permitted controller medications, eg, long-acting Beta2 agonists (LABA), leukotriene receptor antagonists (LTRA), is allowed
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：基礎科学
- 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 |
|---|---|
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実験的：Part 1: Healthy participants (CNTO 3157 + HRV-16)
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CNTO 3157 10 mg/kg, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with human rhinovirus type 16 (HRV-16).
Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
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プラセボコンパレーター：Part 1: Healthy participants (placebo + HRV-16)
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Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
Placebo, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with HRV-16.
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実験的：Part 2: Asthmatic patients (CNTO 3157 + HRV-16)
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Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
CNTO 3157 10 mg/kg, as a single intravenous infusion, at Week 1 (Day 1), followed by 3 infusions of 3 mg/kg of CNTO 3157 at Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22).
The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.
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プラセボコンパレーター：Part 2: Asthmatic patients (placebo + HRV-16)
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Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
Placebo, as 4 intravenous infusions, at Week 1 (Day 1), Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22).
The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.
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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 |
時間枠 |
|---|---|
|
The maximum percent decrease relative to baseline in the prebronchodilator forced expiratory volume in 1 second (FEV1) measurements (Part 2)
時間枠：Up to 10 days after inoculation with human rhinovirus type 16 (HRV-16)
|
Up to 10 days after inoculation with human rhinovirus type 16 (HRV-16)
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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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Area under the serum concentration versus time curve (AUC) of change from baseline in Cold Symptom Assessment Score
時間枠：Up to 10 days after inoculation with HRV-16
|
Cold symptoms is rated using a 5 point scale (0=none and 4=very severe).
Scores can range from 0-32, with higher scores indicating more symptoms.
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Up to 10 days after inoculation with HRV-16
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AUC of change from baseline in Cold and Chest Symptom Scale
時間枠：Up to 10 days after inoculation with HRV-16
|
Cold and chest symptoms are rated using a 5 point scale: 0 using a 5 point scale (0=none and 4=very severe).
Scores can range from 0-60, with higher scores indicating more symptoms.
|
Up to 10 days after inoculation with HRV-16
|
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AUC of change from baseline in log-transformed fractional concentration of exhaled nitric oxide (FENO)
時間枠：Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of the percent change from baseline in clinic assessed prebronchodilator FEV1
時間枠：Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of change from baseline in morning (AM) peak expiratory flow rate (PEFR)
時間枠：Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of the change from baseline in prebronchodilator percent predicted FEV1
時間枠：Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of the change from baseline in prebronchodilator forced vital capacity (FVC)
時間枠：Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of the change from baseline in prebronchodilator forced expiratory flow at 25 to 75% of vital capacity (FEV25-75)
時間枠：Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of the change from baseline in prebronchodilator FEV1/FVC
時間枠：Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of change from baseline in average total asthma symptom diary score
時間枠：Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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Change from baseline in Asthma Control Questionnaire (ACQ)
時間枠：Up to 10 days after inoculation with HRV-16
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ACQ is an instrument designed to evaluate asthma control.
Seven items are scored on a 7-point scale (0=good control, 6=poor control) with the mean score as an overall summary score.
Questions 1-6 are completed by the patient; the last item is entered by site personnel and corresponds to the patient's percent predicted FEV1 categorized according to the 7-point scale.
Higher scores reflect poorer control.
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Up to 10 days after inoculation with HRV-16
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Change from baseline in Cold Symptom Assessment Score
時間枠：Up to 11 weeks
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Clinical symptoms to HRV-16 will be assessed by using the Cold Symptom Assessment Score, wherein participants will report the presence and severity of their cold symptoms in the context of the previous 24 hours via an interactive interview with the study staff.
The symptoms consist of nasal congestion (stuffy nose), rhinorrhea (runny nose), sore throat, sneezing, cough, headache, malaise (feeling run down, tired) and chilliness.
Severity is rated using a 5 point scale (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe).
Scores can range from 0-32, with higher scores indicating more symptoms.
|
Up to 11 weeks
|
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Change from baseline in Cold and Chest Symptom Scale
時間枠：Up to 11 weeks
|
The Cold and Chest Symptom Scale contains 15 items composing 2 domains, a total cold score and a total chest score. Together, these 2 domains comprise the chest symptom assessment score. Total Cold Score domain: sneezing, runny nose, blocked or stuff nose, sore throat or hoarse voice, headache or face pain, generally unwell, chills, fever or shivery and cough and Total Chest Score domain: cough on waking, wheeze on waking, daytime cough, daytime wheeze, daytime chest tightness, daytime breathlessness and nocturnal cough, wheeze and breathlessness. Severity is rated using a 5 point scale: 0 using a 5 point scale (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe). Scores can range from 0-60, with higher scores indicating more symptoms. |
Up to 11 weeks
|
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Change from baseline in log-transformed FENO over time
時間枠：Up to 11 weeks
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Up to 11 weeks
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Change from baseline over time in prebronchodilator and postbronchodilator FEV1
時間枠：Up to 11 weeks
|
Up to 11 weeks
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Change from baseline over time in percent-predicted prebronchodilator and postbronchodilator FEV1
時間枠：Up to 11 weeks
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Up to 11 weeks
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Change from baseline over time in prebronchodilator and postbronchodilator FVC
時間枠：Up to 11 weeks
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Up to 11 weeks
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Change from baseline over time in prebronchodilator and postbronchodilator FEV25-75
時間枠：Up to 11 weeks
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Up to 11 weeks
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Change from baseline over time in prebronchodilator and postbronchodilator FEV1/FVC
時間枠：Up to 11 weeks
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Up to 11 weeks
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Change from baseline in morning/evening PEFR over time
時間枠：Up to 11 weeks
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Up to 11 weeks
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Change from baseline in Total Nasal and Ocular Symptom Score (TNOSS)
時間枠：Up to Day 22
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Nose and eye symptoms are rated by the patient using a 5-point categorical response scale from 0 to 4, where 0 indicates absent/no symptom, and 4 indicates extremely severe symptoms, with a 24-hour recall period.
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Up to Day 22
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Change from baseline in average total asthma symptom diary score
時間枠：Up to 11 weeks
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Up to 11 weeks
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Change from baseline in average number of nocturnal awakenings
時間枠：Up to 11 weeks
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Up to 11 weeks
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Change from baseline in average rescue medication use over time
時間枠：Up to 11 weeks
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Up to 11 weeks
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Number of symptom-free days
時間枠：Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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The maximum decrease from baseline in the prebronchodilator FEV1 measurements
時間枠：Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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Time to the maximum decrease relative to baseline in prebronchodilator FEV1
時間枠：Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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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。
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。
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
2012年10月1日
一次修了 (実際)
2014年11月1日
研究の完了 (実際)
2014年11月1日
試験登録日
最初に提出
2012年10月8日
QC基準を満たした最初の提出物
2012年10月10日
最初の投稿 (見積もり)
2012年10月11日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年12月12日
QC基準を満たした最後の更新が送信されました
2014年12月11日
最終確認日
2014年12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。