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Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma

2020年4月9日 更新者：Vectura Limited

A Randomised Double-blind, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of VR506 From a New Dry Powder Inhaler in Subjects With Severe Persistent Asthma Requiring Oral Corticosteroid Therapy.

To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines 2011.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

197

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 乌克兰
      • AR Crimea、乌克兰、97403
        • Vectura Clinical Trial Site 06013
      • Donetsk、乌克兰、83099
        • Vectura Clinical Trial Site 06009
      • Ivano-Frankivsk、乌克兰、76018
        • Vectura Clinical Trial Site 06012
      • Kharkiv、乌克兰、61002
        • Vectura Clinical Trial Site 06010
      • Kharkiv、乌克兰、61035
        • Vectura Clinical Trial Site 06001
      • Kharkiv、乌克兰、61106
        • Vectura Clinical Trial Site 06004
      • Kyiv、乌克兰、02232
        • Vectura Clinical Trial Site 06006
      • Kyiv、乌克兰、03680
        • Vectura Clinical Trial Site 06002
      • Kyiv、乌克兰、3680
        • Vectura Clinical Trial Site 06015
      • Kyviv、乌克兰、04050
        • Vectura Clinical Trial Site 06003
      • Mykolaiv、乌克兰、54003
        • Vectura Clinical Trial Site 06008
      • Vinnitsa、乌克兰、21029
        • Vectura Clinical Trial Site 06011
      • Zaporizhzhia、乌克兰、69600
        • Vectura Clinical Trial Site 06007
      • Zaporizhzhya、乌克兰、69118
        • Vectura Clinical Trial Site 06014
  • 保加利亚
      • Ruse、保加利亚、7000
        • Vectura Clinical Trial Site 08006
      • Sofia、保加利亚、1000
        • Vectura Clinical Trial Site 08005
      • Sofia、保加利亚、1431
        • Vectura Clinical Trial Site 08001
      • Sofia、保加利亚、1431
        • Vectura Clinical Trial Site 08003
      • Sofia、保加利亚、1431
        • Vectura Clinical Trial Site 08007
      • Sofia、保加利亚、1606
        • Vectura Clinical Trial Site 08004
      • Stara Zagora、保加利亚、6000
        • Vectura Clinical Trial Site 08002
      • Varna、保加利亚、9000
        • Vectura Clinical Trial Site 08008
  • 匈牙利
      • Budapest、匈牙利、1121
        • Vectura Clinical Trial Site 04001
      • Budapest、匈牙利、1125
        • Vectura Clinical Trial Site 04004
      • Debrecen、匈牙利、4032
        • Vectura Clinical Trial Site 04003
      • Rakoczi、匈牙利、125 127
        • Vectura Clinical Trial Site 04002
      • Rakoczi、匈牙利、7100
        • Vectura Clinical Trial Site 04005
  • 德国
      • Berlin、德国、10717
        • Vectura Clinical Trial Site 03006
      • Berlin、德国、12203
        • Vectura Clinical Trial Site 03009
      • Bonn、德国、53119
        • Vectura Clinical Trial Site 03004
      • Donaustauf、德国、93093
        • Vectura Clinical Trial Site 03008
      • Dortmund、德国、44263
        • Vectura Clinical Trial Site 03003
      • Geesthacht、德国、21502
        • Vectura Clinical Trial Site 03007
      • Hamburg、德国、22767
        • Vectura Clinical Trial Site 03001
      • Heidelberg、德国、69126
        • Vectura Clinical Trial Site 03005
      • Rudersdorf、德国、15562
        • Vectura Clinical Trial Site 03002
  • 波兰
      • Bialystok、波兰、15-003
        • Vectura Clinical Trial Site 05008
      • Bialystok、波兰、15-276
        • Vectura Clinical Trial Site 05002
      • Bialystok、波兰、15-430
        • Vectura Clinical Trial Site 05010
      • Krakow、波兰、31-024
        • Vectura Clinical Trial Site 05011
      • Lodz、波兰、90-153
        • Vectura Clinical Trial Site 05001
      • Lodz、波兰、90-153
        • Vectura Clinical Trial Site 05006
      • Lublin、波兰、20-552
        • Vectura Clinical Trial Site 05005
      • Tarnow、波兰、33-100
        • Vectura Clinical Trial Site 05007
      • Warszawa、波兰、02-097
        • Vectura Clinical Trial Site 05003
      • Wroclaw、波兰、51-162
        • Vectura Clinical Trial Site 05009
      • Zawadzkie、波兰、47-120
        • Vectura Clinical Trial Site 05004
  • 罗马尼亚
      • Brasov、罗马尼亚、500086
        • Vectura Clinical Trial Site 07001
      • Bucuresti、罗马尼亚、010457
        • Vectura Clinical Trial Site 07008
      • Bucuresti、罗马尼亚、020671
        • Vectura Clinical Trial Site 07005
      • Bucuresti、罗马尼亚、030303
        • Vectura Clinical Trial Site 07013
      • Bucuresti、罗马尼亚、050554
        • Vectura Clinical Trial Site 07003
      • Cluj-Napoca、罗马尼亚、400371
        • Vectura Clinical Trial Site 07006
      • Cluj-Napoca、罗马尼亚、400371
        • Vectura Clinical Trial Site 07007
      • Cluj-Napoca、罗马尼亚、400371
        • Vectura Clinical Trial Site 07009
      • Cod、罗马尼亚、700115
        • Vectura Clinical Trial Site 07010
      • Craiova、罗马尼亚、200515
        • Vectura Clinical Trial Site 07014
      • Iasi、罗马尼亚、700376
        • Vectura Clinical Trial Site 07002
      • Marghita、罗马尼亚、415300
        • Vectura Clinical Trial Site 07004
      • Targu Mures、罗马尼亚、540543
        • Vectura Clinical Trial Site 07012
      • Timis、罗马尼亚、300310
        • Vectura Clinicl Trial Site 07011
  • 美国
    • California
      • Los Angeles、California、美国、90025
        • Vectura Clinical Trial Site 01001
    • Colorado
      • Denver、Colorado、美国、80206
        • Vectura Clinial Trial Site 01005
    • Florida
      • Celebration、Florida、美国、34747
        • Vectura Clinical Trial Site 01006
      • Hialeah、Florida、美国、33018
        • Vectura Clinical Trial Site 01015
      • Miami Lakes、Florida、美国、33016
        • Vectura Clinical Trial Site 01012
      • Orlando、Florida、美国、32806
        • Vectura Clinical Trial Site 01014
      • Tampa、Florida、美国、33613
        • Vectura Clinical Trial Site 01003
    • Missouri
      • Saint Louis、Missouri、美国、63110-1093
        • Vectura Clinical Trial Site 01011
    • New Jersey
      • Jersey City、New Jersey、美国、07306
        • Vectura Clinical Trial Site 01013
    • New York
      • Bronx、New York、美国、10461
        • Vectura Clinical Trial Site 01004
    • Texas
      • El Paso、Texas、美国、79925
        • Vectura Clinical Trial Site 01007
  • 英国
      • Birmingham、英国、B9 5SS
        • Vectura Clinical Trial site 02002
      • Manchester、英国、M23 9LT
        • Vectura Clinical Trial Site 02004
      • Newcastle、英国、NE7 7DN
        • Vectura Clinical Trial Site 02001
      • Nottingham、英国、NG5 1PB
        • Vectura Clinical Trial Site 02005
    • Hull
      • Cottingham、Hull、英国、HU16 5JQ
        • Vectura Clinical Trial Site 02003

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 65年 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion:

  • Written informed consent
  • Adolescents aged 12-17 years & adults aged 18-65 years (both inclusive)
  • Documented clinical history of severe asthma requiring prednisone/prednisolone therapy, high-intensity treatment ICS, OCS, LABA
  • Stable OCS dose for ≥7 days before Screening Visit & during Screening Period.
  • At least 80% compliant w/regular asthma medication per investigator at end of Screening Period
  • Documented asthma reversibility within 5 yrs prior to/during Screening Period, or diagnosis of asthma that is incontrovertible per investigator
  • Ability to use nDPI correctly, per investigator's review of completed inhaler operation checklist
  • Ability to use eDiary correctly, assessed by investigator at end of Screening Period
  • Ability to comply w/study procedures, including blood sampling
  • Ability to perform technically satisfactory pulmonary function tests
  • Available to complete all study visits before 12 noon
  • BMI of 16-26 kg/m2 in adolescents and 18-32 kg/m2 in adults
  • Oral PIF ≥40 L/min, using an appropriate device set to match resistance of inhaler
  • Good health, except for presence of asthma, per medical history/physical examination
  • Negative drug/alcohol/urine cotinine screen. Subjects must test negative for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine, ethanol & opiates (unless given as prescription medicine)
  • Non-smokers or ex-smokers with a smoking history of less than 10 pack-yrs (e.g. <20 cigarettes per day for 10 years or <40 cigarettes per day for 5 years) & stopped smoking for at least 1 year prior to Screening Visit. Smoking will not be permitted throughout study
  • Female subjects of child-bearing potential must be using medically acceptable forms of contraception [abstinence, hormonal (oral/implant/transdermal/injection), in use for ≥3 consecutive months before first dose of study medication, double barrier (condom w/spermicide, or diaphragm w/spermicide), IUD, or vasectomised partner (≥6 months since vasectomy)].

Exclusion:

  • Regular use (≥3 times/wk) of topical steroids to treat dermatitis/rhinitis/allergic conjunctivitis, within 28 days of Screening Visit
  • Subjects who have/who have had, an upper/lower respiratory tract infection within 28 days of Screening Visit
  • Subjects w/"brittle asthma
  • Subjects w/asthma that required admission to an ICU and/or ventilation within previous 12 months
  • Subjects whose comorbidities, per investigator's opinion, are major contributors to their respiratory symptoms (e.g. COPD, bronchiectasis, dysfunctional breathlessness, vocal cord dysfunction, gastro-oesophageal reflux)
  • Previously/currently diagnosed as having Churg-Strauss syndrome
  • Previously/currently diagnosed as having pulmonary eosinophilia
  • History of lung cancer
  • Subjects w/current diagnosis of HIV infection
  • Active chronic hepatitis B or C infection
  • Subjects who have clinically significant abnormality/finding from examination, tests, or history that may compromise subject safety, specifically any history of cardiac, renal or hepatic impairment
  • Subjects with an abnormal ECG
  • Persistent arterial hypotension, with average SBP readings of ≤95 mmHg
  • Persistent elevation of blood pressure, with average SBP readings of ≥160 mmHg or average DBP readings of ≥100 mmHg
  • Pregnant or lactating females
  • Participation in another clinical study in 28 days prior to Screening Visit
  • Evidence of clinically significant renal, hepatic, cardiac, pulmonary (apart from asthma) or metabolic dysfunction, e.g. diabetes mellitus, thyrotoxicosis, uncorrectable hypokalaemia, or predisposition to low levels of serum potassium
  • Current/history of drug/alcohol abuse/dependence per WHO criteria
  • Inability to communicate well w/investigator
  • Donation of ≥450 mL of blood/blood products within previous 3 months prior to screening
  • History of allergy/intolerance/contraindications to corticosteroids/lactose, or severe allergy to milk proteins
  • Consumption of alcohol- or caffeine-containing foods/beverages from midnight before or during Screening Visit
  • History of medically diagnosed chronic respiratory diseases other than asthma (e.g. chronic obstructive pulmonary disease, ABPA in the absence of asthma)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器：Dose 1 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
药品：VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
有源比较器：Dose 2 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
药品：VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
有源比较器：Dose 3 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
药品：VR506
VR506 inhalation powder delivered via a new dry powder inhaler device

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
大体时间：16 weeks
The mean asthma control prednisone/prednisolone dose at end of study (week 16)
16 weeks

次要结果测量

结果测量
措施说明
大体时间
Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)
大体时间：Baseline and 16 weeks
Baseline and 16 weeks
Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score
大体时间：Baseline and 16 weeks
Change from baseline to end of study (week 16) in 5 item asthma control questionnaire (ACQ-5) mean total score (range 0 (better) to 6 (worse)). The mean total score is calculated as the mean for each subject at each visit of 5 questions, each scored from 0 (better) to 6 (worse).
Baseline and 16 weeks
Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)
大体时间：Baseline and 16 weeks
Baseline and 16 weeks
Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Weekly Average Asthma Night-time Symptom Score
大体时间：Baseline and 16 weeks
To measure the change from baseline to end of study for the weekly mean asthma night time symptom score, scored from 0 (not at all bothered) to 6 (severely bothered).
Baseline and 16 weeks
Number of Participants With Withdrawals Due to Worsening of Asthma
大体时间：16 weeks
16 weeks
Assessment of Acceptability of the Device
大体时间：16 weeks
Percentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire
16 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Vectura Limited

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年10月1日

初级完成 (实际的)

2013年10月1日

研究完成 (实际的)

2013年10月1日

研究注册日期

首次提交

2012年10月30日

首先提交符合 QC 标准的

2012年10月30日

首次发布 (估计)

2012年11月1日

研究记录更新

最后更新发布 (实际的)

2020年4月21日

上次提交的符合 QC 标准的更新

2020年4月9日

最后验证

2020年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • VR506/2/004

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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