Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma
2020년 4월 9일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
197
단계
- 2 단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Berlin, 독일, 10717
- Vectura Clinical Trial Site 03006
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Berlin, 독일, 12203
- Vectura Clinical Trial Site 03009
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Bonn, 독일, 53119
- Vectura Clinical Trial Site 03004
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Donaustauf, 독일, 93093
- Vectura Clinical Trial Site 03008
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Dortmund, 독일, 44263
- Vectura Clinical Trial Site 03003
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Geesthacht, 독일, 21502
- Vectura Clinical Trial Site 03007
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Hamburg, 독일, 22767
- Vectura Clinical Trial Site 03001
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Heidelberg, 독일, 69126
- Vectura Clinical Trial Site 03005
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Rudersdorf, 독일, 15562
- Vectura Clinical Trial Site 03002
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Brasov, 루마니아, 500086
- Vectura Clinical Trial Site 07001
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Bucuresti, 루마니아, 010457
- Vectura Clinical Trial Site 07008
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Bucuresti, 루마니아, 020671
- Vectura Clinical Trial Site 07005
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Bucuresti, 루마니아, 030303
- Vectura Clinical Trial Site 07013
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Bucuresti, 루마니아, 050554
- Vectura Clinical Trial Site 07003
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Cluj-Napoca, 루마니아, 400371
- Vectura Clinical Trial Site 07006
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Cluj-Napoca, 루마니아, 400371
- Vectura Clinical Trial Site 07007
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Cluj-Napoca, 루마니아, 400371
- Vectura Clinical Trial Site 07009
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Cod, 루마니아, 700115
- Vectura Clinical Trial Site 07010
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Craiova, 루마니아, 200515
- Vectura Clinical Trial Site 07014
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Iasi, 루마니아, 700376
- Vectura Clinical Trial Site 07002
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Marghita, 루마니아, 415300
- Vectura Clinical Trial Site 07004
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Targu Mures, 루마니아, 540543
- Vectura Clinical Trial Site 07012
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Timis, 루마니아, 300310
- Vectura Clinicl Trial Site 07011
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California
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Los Angeles, California, 미국, 90025
- Vectura Clinical Trial Site 01001
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Colorado
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Denver, Colorado, 미국, 80206
- Vectura Clinial Trial Site 01005
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Florida
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Celebration, Florida, 미국, 34747
- Vectura Clinical Trial Site 01006
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Hialeah, Florida, 미국, 33018
- Vectura Clinical Trial Site 01015
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Miami Lakes, Florida, 미국, 33016
- Vectura Clinical Trial Site 01012
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Orlando, Florida, 미국, 32806
- Vectura Clinical Trial Site 01014
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Tampa, Florida, 미국, 33613
- Vectura Clinical Trial Site 01003
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Missouri
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Saint Louis, Missouri, 미국, 63110-1093
- Vectura Clinical Trial Site 01011
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New Jersey
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Jersey City, New Jersey, 미국, 07306
- Vectura Clinical Trial Site 01013
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New York
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Bronx, New York, 미국, 10461
- Vectura Clinical Trial Site 01004
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Texas
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El Paso, Texas, 미국, 79925
- Vectura Clinical Trial Site 01007
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Ruse, 불가리아, 7000
- Vectura Clinical Trial Site 08006
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Sofia, 불가리아, 1000
- Vectura Clinical Trial Site 08005
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Sofia, 불가리아, 1431
- Vectura Clinical Trial Site 08001
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Sofia, 불가리아, 1431
- Vectura Clinical Trial Site 08003
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Sofia, 불가리아, 1431
- Vectura Clinical Trial Site 08007
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Sofia, 불가리아, 1606
- Vectura Clinical Trial Site 08004
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Stara Zagora, 불가리아, 6000
- Vectura Clinical Trial Site 08002
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Varna, 불가리아, 9000
- Vectura Clinical Trial Site 08008
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Birmingham, 영국, B9 5SS
- Vectura Clinical Trial site 02002
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Manchester, 영국, M23 9LT
- Vectura Clinical Trial Site 02004
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Newcastle, 영국, NE7 7DN
- Vectura Clinical Trial Site 02001
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Nottingham, 영국, NG5 1PB
- Vectura Clinical Trial Site 02005
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Hull
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Cottingham, Hull, 영국, HU16 5JQ
- Vectura Clinical Trial Site 02003
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AR Crimea, 우크라이나, 97403
- Vectura Clinical Trial Site 06013
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Donetsk, 우크라이나, 83099
- Vectura Clinical Trial Site 06009
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Ivano-Frankivsk, 우크라이나, 76018
- Vectura Clinical Trial Site 06012
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Kharkiv, 우크라이나, 61002
- Vectura Clinical Trial Site 06010
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Kharkiv, 우크라이나, 61035
- Vectura Clinical Trial Site 06001
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Kharkiv, 우크라이나, 61106
- Vectura Clinical Trial Site 06004
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Kyiv, 우크라이나, 02232
- Vectura Clinical Trial Site 06006
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Kyiv, 우크라이나, 03680
- Vectura Clinical Trial Site 06002
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Kyiv, 우크라이나, 3680
- Vectura Clinical Trial Site 06015
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Kyviv, 우크라이나, 04050
- Vectura Clinical Trial Site 06003
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Mykolaiv, 우크라이나, 54003
- Vectura Clinical Trial Site 06008
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Vinnitsa, 우크라이나, 21029
- Vectura Clinical Trial Site 06011
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Zaporizhzhia, 우크라이나, 69600
- Vectura Clinical Trial Site 06007
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Zaporizhzhya, 우크라이나, 69118
- Vectura Clinical Trial Site 06014
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Bialystok, 폴란드, 15-003
- Vectura Clinical Trial Site 05008
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Bialystok, 폴란드, 15-276
- Vectura Clinical Trial Site 05002
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Bialystok, 폴란드, 15-430
- Vectura Clinical Trial Site 05010
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Krakow, 폴란드, 31-024
- Vectura Clinical Trial Site 05011
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Lodz, 폴란드, 90-153
- Vectura Clinical Trial Site 05001
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Lodz, 폴란드, 90-153
- Vectura Clinical Trial Site 05006
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Lublin, 폴란드, 20-552
- Vectura Clinical Trial Site 05005
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Tarnow, 폴란드, 33-100
- Vectura Clinical Trial Site 05007
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Warszawa, 폴란드, 02-097
- Vectura Clinical Trial Site 05003
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Wroclaw, 폴란드, 51-162
- Vectura Clinical Trial Site 05009
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Zawadzkie, 폴란드, 47-120
- Vectura Clinical Trial Site 05004
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Budapest, 헝가리, 1121
- Vectura Clinical Trial Site 04001
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Budapest, 헝가리, 1125
- Vectura Clinical Trial Site 04004
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Debrecen, 헝가리, 4032
- Vectura Clinical Trial Site 04003
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Rakoczi, 헝가리, 125 127
- Vectura Clinical Trial Site 04002
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Rakoczi, 헝가리, 7100
- Vectura Clinical Trial Site 04005
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
12년 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Dose 1 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
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VR506 inhalation powder delivered via a new dry powder inhaler device
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활성 비교기: Dose 2 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
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VR506 inhalation powder delivered via a new dry powder inhaler device
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활성 비교기: Dose 3 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
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VR506 inhalation powder delivered via a new dry powder inhaler device
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
기간: 16 weeks
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The mean asthma control prednisone/prednisolone dose at end of study (week 16)
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16 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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)
기간: Baseline and 16 weeks
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Baseline and 16 weeks
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Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score
기간: Baseline and 16 weeks
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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).
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Baseline and 16 weeks
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Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)
기간: Baseline and 16 weeks
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Baseline and 16 weeks
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Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Weekly Average Asthma Night-time Symptom Score
기간: Baseline and 16 weeks
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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).
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Baseline and 16 weeks
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Number of Participants With Withdrawals Due to Worsening of Asthma
기간: 16 weeks
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16 weeks
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Assessment of Acceptability of the Device
기간: 16 weeks
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Percentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire
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16 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 10월 1일
기본 완료 (실제)
2013년 10월 1일
연구 완료 (실제)
2013년 10월 1일
연구 등록 날짜
최초 제출
2012년 10월 30일
QC 기준을 충족하는 최초 제출
2012년 10월 30일
처음 게시됨 (추정)
2012년 11월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 4월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 4월 9일
마지막으로 확인됨
2020년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .