조절된 천식 환자에서 포스터 100/6mg NEXThaler와 포스터 100/6mg 가압 정량 흡입기(pMDI) 비교. (FORTUNE)
Foster 100/6mg NEXThaler, 2회 흡입 b.i.d, 대 Foster 100/6mg pMDI, 2회 퍼프 b.i.d의 효능 및 안전성을 비교한 12주, 다기관, 무작위, 이중 맹검, 이중 더미, 2군 병렬 그룹 연구 통제된 천식 환자
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This was a phase III, multinational, multicentre, randomised, double-blind, double-dummy, active-control, 2-arm parallel group study designed to evaluate the non-inferiority of Foster® NEXThaler® 100/6 µg (400/24 µg/day) versus Foster® pMDI 100/6 µg (400/24 µg/day) in patients with controlled asthma.
The study included the following phases:
- Pre-Screening Phase (Visit 0): Conducted within a maximum of 7 days before the screening visit (Visit 1), this phase provided patients with study details, obtained informed consent, and outlined medication restrictions.
- Screening and Run-in Phase (Visit 1, Week -4 to Visit 2, Week -2): Patients underwent eligibility assessments and transitioned into a 4-week open-label run-in period with Foster® pMDI 100/6 µg (400/24 µg/day) to establish baseline parameters.
- Randomisation Phase (Visit 3, Week 0): Eligible patients were randomised in a 1:1 ratio to receive either Foster® NEXThaler® 100/6 µg 2 inhalations bid (for a total daily dose of 400/24 µg/day) or Foster® pMDI 100/6 µg, 2 puffs bid (for a total daily dose of 400/24 µg/day) for 12 weeks. The allocation was managed via an Interactive Web Response System (IWRS) to ensure balanced treatment groups.
- Investigational Phase (Treatment Period: Weeks 0-12): Patients attended scheduled visits at Weeks 2, 4, 6, 8, 10, and 12 to monitor efficacy and safety.
Daily, patients recorded pre-dose morning and evening Peak Expiratory Flow (PEF), rescue medication use, and asthma symptoms using an electronic peak flow meter and e-diary. At each visit, lung function (FEV1, FVC, and PEF), asthma symptom scores, and rescue medication use were assessed. Vital signs (heart rate, blood pressure) and safety outcomes (adverse events, serious adverse events, and laboratory assessments) were monitored.
- Follow-Up Phase: A safety follow-up phone call was conducted 7-10 days after the final visit (Week 12) or early termination to assess any unresolved adverse events (AEs) or new concomitant medications.
The total study duration per participant was 16 weeks, including the 4-week run-in period, 12-week treatment phase, and 1-week follow-up. This design ensured a standardized baseline before randomisation and provided sufficient time to assess both primary and secondary endpoints.
Salbutamol (purchased locally and provided by the Investigator site to the patient) was used as a rescue medication.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
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Beijing, 중국, 100144
- Chiesi Clinical Trial site 15672
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Beijing, 중국
- Chiesi clinical Trial site 15636
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Chongqing, 중국
- Chiesi Clinical Trial site 15638
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Guizhou, 중국
- Chiesi Clinical Trial site 15670
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Hebei, 중국
- Chiesi clinical Trial Site 15611
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Jilin City, 중국
- Chiesi Clinical trial site 15660
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Shanghai, 중국
- Chiesi Clinical Trial site 15628
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Shanghai, 중국
- Chiesi clinical trial site 15637
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Shenzhen, 중국
- Chiesi Clinical Trial site 15666
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Sichuan, 중국
- Chiesi clinical Trial site 15633
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Ürümqi, 중국, 830054
- Chiesi Clinical Trial site 15669
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Anhui
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Hefei, Anhui, 중국
- Chiesi Clinical Trial site 15641
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100000
- Chiesi Clinical Trial site 15682
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Beijing, Beijing Municipality, 중국, 101100
- Chiesi Clinical Trial site 15663
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Guangdong
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Foshan, Guangdong, 중국
- Chiesi Clinical Trial site 15662
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Guangzhou, Guangdong, 중국, 5100150
- Chiesi Clinical Trial site 15671
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Guangzhou, Guangdong, 중국, 510120
- Chiesi Clinical Trial site 15610
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Guangzhou, Guangdong, 중국
- Chiesi clinical Trial site 15656
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Guangzhou, Guangdong, 중국
- Chiesi Clinical Trial site 15668
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Huizhou, Guangdong, 중국, 516001
- Chiesi Clinical Trial site 15677
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Shenzhen, Guangdong, 중국, 518052
- Chiesi Clinical Trial site 15683
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Shenzhen, Guangdong, 중국
- Chiesi Clinical Trial site 15608
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Zhanjiang, Guangdong, 중국, 524001
- Chiesi Clinical Trial site 15607
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Guangzhou
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Guangzhou, Guangzhou, 중국, 511400
- Chiesi Clinical Trial site 15610
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Hainan
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Haikou, Hainan, 중국, 570208
- Chiesi Clinical Trial site 15673
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Heilongjiang
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Qiqihar, Heilongjiang, 중국, 161002
- Chiesi Clinical Trial site 15678
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Henan
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Xinxiang, Henan, 중국, 453000
- Chiesi Clinical Trial site 15681
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Zhengzhou, Henan, 중국, 450003
- Chiesi Clinical Trial site 15679
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Hubei
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Wuhan, Hubei, 중국, 430030
- Chiesi Clinical Trial site 15614
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Wuhan, Hubei, 중국
- Chiesi Clinical Trial site 15661
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Hunan
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Hengyang, Hunan, 중국, 421000
- Chiesi Clinical Trial site 15675
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Jiangsu
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Changzhou, Jiangsu, 중국, 213164
- Chiesi Clinical Trial site 15643
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Jiangxi
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Pingxiang, Jiangxi, 중국, 337055
- Chiesi Clinical Trial site 15674
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Jilin
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Jilin City, Jilin, 중국, 132011
- Chiesi Clinical Trial site 15676
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Liaoning
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Shenyang, Liaoning, 중국
- Chiesi clinical Trial site 15621
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Nanchang
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Nanchang, Nanchang, 중국, 330006
- Chiesi clinical Trial site 15619
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Neimenggu
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Hohhot, Neimenggu, 중국, 010017
- Chiesi Clinical Trial site 15650
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Hohhot, Neimenggu, 중국
- Chiesi clinical Trial site 15659
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200025
- Chiesi Clinical Trial site 15630
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Shanghai, Shanghai Municipality, 중국, 200050
- Chiesi Clinical Trial site 15664
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Shanghai, Shanghai Municipality, 중국, 201100
- Chiesi Clinical Trial site 15654
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Shanghai, Shanghai Municipality, 중국
- Chiesi Clinical Trial site 15630
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Shanghai, Shanghai Municipality, 중국
- Chiesi Clinical Trial site 15631
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Shanghai, Shanghai Municipality, 중국
- Chiesi Clinical Trial site 15665
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Shanxi
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Taiyuan, Shanxi, 중국, 030001
- Chiesi Clinical Trial site 15625
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Shijiazhuang
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Shijiazhuang, Shijiazhuang, 중국, 050000
- Chiesi clinical Trial Site 15611
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Sichuan
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Chengdu, Sichuan, 중국, 610041
- Chiesi clinical Trial site 15633
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Chongqing, Sichuan, 중국, 408499
- Chiesi Clinical Trial site 15680
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Tianjin Municipality
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Tianjin, Tianjin Municipality, 중국, 300052
- Chiesi Clinical Trial site 15642
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Tianjin, Tianjin Municipality, 중국, 300350
- Chiesi Clinical Trial site 15634
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Xian
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Xi'an, Xian, 중국, 710061
- Chiesi Clinical Trial site 15626
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 남성 또는 여성 외래 환자, 2016 글로벌 이니셔티브 천식(GINA) 업데이트된 국제 지침에 따라 흉부 의사가 확인한 1차 방문 전 최소 6개월 동안 천식 임상 진단을 받은 >18세 중국 민족.
- 가역성 테스트에 대한 긍정적인 반응.
- FEV 1(첫 번째 1초 내 강제 호기량) 기관지확장제를 적절히 사용한 후 예상 정상 값의 >80%.
- 고용량의 ICS(흡입 코르티코스테로이드) 또는 중간 용량의 ICS와 함께 방문 1 이전 최소 3개월 동안 안정적인 용량으로 이전에 정기적인 치료를 받은 환자
제외 기준:
- 임산부 또는 수유부
- 간헐적 천식 또는 알레르겐 또는 화학 감작제에 간헐적으로 노출되는 경우에만 발생하는 천식
- 2016년 업데이트된 만성 폐쇄성 폐질환(GOLD) 지침에 대한 현재 Glocal Initiative에서 정의한 만성 폐쇄성 폐질환(COPD) 진단
- 현재 흡연자 또는 과거 흡연자
- 포함 전 1개월 이내에 전신 코르티코스테로이드(> 10일)의 섭취로 이어지는 중증 천식 악화 또는 중등도/중증 천식 악화
- 단클론 항체로 치료받은 환자
- 비칼륨보존성 이뇨제를 투여받은 환자
- 모노아민 옥시다제 억제제 및 삼환계 항우울제로 치료받는 환자
- 스테로이드와 상호 작용할 수 있는 치료를 받고 있는 환자
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Foster 100/6µg NEXThaler
Patients in this arm received Foster® NEXThaler® 100/6 µg, a fixed-dose combination of beclometasone dipropionate (BDP) 100 µg and formoterol fumarate (FF) 6 µg per actuation, delivered via a breath-actuated dry powder inhaler (DPI). Treatment Details:
Blinding & Control Treatment:
Background Therapy:
Patient Training & Compliance:
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A fixed combination of beclometasone dipropionate 100 µg and formoterol fumarate 6 µg per actuation, delivered via a breath-actuated dry powder inhaler (DPI).
다른 이름들:
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활성 비교기: Foster 100/6µg pMDI
Patients in this arm received Foster® pMDI 100/6 µg, a fixed-dose combination of beclometasone dipropionate (BDP) 100 µg and formoterol fumarate (FF) 6 µg per actuation, delivered via a pressurized metered-dose inhaler (pMDI). Treatment Details:
Blinding & Control Treatment:
Background Therapy:
Patient Training & Compliance:
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A fixed combination of beclometasone dipropionate 100 µg and formoterol fumarate 6 µg per actuation, delivered via a pressurized metered-dose inhaler (pMDI) with HFA_134a propellant.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline to End of Treatment Period in Average Pre-dose Morning Peak Expiratory Flow (PEF)
기간: Baseline (Week 0, Visit 3) and Week 12 (EoT)
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PEF= peak expiratory flow. The peak expiratory flow (also known as a peak flow or peak flow rate) is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. In this study PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded.
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Baseline (Week 0, Visit 3) and Week 12 (EoT)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline to Each 2-week (Inter-visit) Treatment Period in Average Pre-dose Morning Peek Expiratory Flow (PEF)
기간: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
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PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: in the morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded.
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Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
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Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Pre-dose Evening PEF
기간: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks.
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PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded.
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Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks.
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Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Daily PEF Variability
기간: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded.
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Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Use of Rescue Medication (Number of Puffs/Day)
기간: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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Rescue medication use was recorded daily in an electronic diary, with puffs taken during the day recorded in the evening session and puffs taken at night recorded the next morning.
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Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Percentage of Rescue Medication-Free Days
기간: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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Rescue medication use was recorded daily in an electronic diary, with puffs taken during the day recorded in the evening session and puffs taken at night recorded the next morning.
(Number of days with no rescue medication use / Total number of days with available data)×100
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Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Total Morning Asthma Symptom Score
기간: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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Asthma symptoms (cough, wheeze, chest tightness and breathlessness) were scored, always before PEF measurements, twice daily - daytime and nighttime - as follows: Daytime asthma symptom score (ranging 0-3, where the lower the score the better the outcome): 0 No symptom
Total average Daily Asthma Symptoms score daytime = Σ(Cough daytime score + Wheeze daytime score + Chest Tightness daytime score + Breathlessness daytime score)/ Number of days with available data. The average of daytime asthma symptoms is the mean value of all daytime measurements, ranging from 0 (no symptoms) to 12 (maximum severity). The lower the score, the better the symptom. |
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Total Evening Asthma Symptom Scores
기간: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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Asthma symptoms (cough, wheeze, chest tightness and breathlessness) were scored, always before PEF measurements, twice daily - daytime and nighttime - as follows: Nighttime asthma symptom score (ranging 0-3, where the lower the score the better the outcome): 0 No symptom
Total average Daily Asthma Symptoms score nighttime = Σ(Cough nighttime score + Wheeze nighttime score + Chest Tightness nighttime score + Breathlessness nighttime score)/ Number of days with available data. The average of nighttime asthma symptoms is the mean value of all nighttime measurements, ranging from 0 (no symptoms) to 12 (maximum severity). The lower the score, the better the symptom. |
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Percentage of Asthma Symptom-Free Days
기간: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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An asthma symptom-free day was defined as a day with both total morning and total evening asthma symptom scores = 0. Only days with both scores available were included.
(Number of symptom-free days / Total number of days with available data)×100
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Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Percentage of Asthma Control Days
기간: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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An asthma control day was defined as a day without rescue medication use and with both total morning and total evening asthma symptom scores = 0. Only days with both scores available were included in the calculation.
(Number of asthma control days / Total number of days with available data)×100
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Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
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Change From Baseline in Pre-Dose Morning FEV1 at Each Clinic Visit
기간: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
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Forced Expiratory Volume in 1 second (FEV1) was measured pre-dose in the morning (7:00-9:00 am) at each clinic visit using spirometry, following standardized procedures. Baseline FEV1 was recorded at Visit 3 (Week 0, randomization), and changes were assessed at each visit (Weeks 2, 4, 6, 8, 10, and 12). Patients performed spirometry in a seated position, using the same calibrated spirometer across all visits. They inhaled deeply to total lung capacity and exhaled forcefully and completely. At least three acceptable maneuvers were required, with the highest valid measurement recorded. FEV1 was expressed in liters (L), and a higher value indicated better lung function. |
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
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Change From Baseline in Pre-Dose Morning FVC at Each Clinic Visit
기간: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
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Forced vital capacity (FVC) is the maximum capacity of air that a patient can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. FVC was measured pre-dose in the morning (7:00-9:00 am) at each clinic visit using spirometry, following standardized procedures. Baseline FVC was recorded at Visit 3 (Week 0, randomization), and changes were assessed at each visit (Weeks 2, 4, 6, 8, 10, and 12). Patients performed spirometry in a seated position, ensuring consistency across visits. They were instructed to inhale deeply to full lung capacity and exhale forcefully and completely into the spirometer. At least three acceptable maneuvers were required per session, with the highest valid measurement recorded. The higher the capacity, measured in liters, the better the outcome. |
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
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Change From Baseline to Last Visit in ACQ-6 Score
기간: Week 12 (Visit 9, End of Treatment - EOT)
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The ACQ-6 was a validated questionnaire assessing asthma control, consisting of six items: five on asthma symptoms (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and one on rescue medication use, all self-administered. Each item was scored from 0 (no impairment) to 6 (maximum impairment), and the ACQ-6 total score was the mean of all six items, ranging from 0 (totally controlled asthma) to 6 (severely uncontrolled asthma). Hence, the higher the score, the worse the outcome. Baseline ACQ-6 was assessed at Visit 3 (Week 0, randomization), and the final score was recorded at Visit 9 (Week 12, EOT). The change from baseline was calculated as the difference between these values . |
Week 12 (Visit 9, End of Treatment - EOT)
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Number of Participants With at Least One Adverse Event (TEAE) or Adverse Drug Reaction (ADR)
기간: From Week 0 (Visit 3, Randomization) to Week 12 (Visit 9, EoT)
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An adverse event (AE) was defined as "any untoward medical occurrence in a patient or clinical study patient administered a medicinal product and which did not necessarily have a causal relationship with this treatment". An AE could therefore be any unfavourable and unintended sign (including abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An adverse drug reaction (ADR) was defined as an "untoward and unintended response to an investigational medicinal product related to any dose administered". An SAE/serious ADR was defined as any untoward medical occurrence or effect that at any dose Resulted in death, Was life-threatening, Required hospitalisation or prolongation of existing hospitalisation, Resulted in persistent or significant disability or incapacity, Was a congenital anomaly or birth defect, Was a medically significant AE. |
From Week 0 (Visit 3, Randomization) to Week 12 (Visit 9, EoT)
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Jinping MD Zheng, The First Affiliated Hospital of Guangzhou Medical University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- CCD-01535BA0-01
- CTR20170917 (기타 식별자: http://www.chinadrugtrials.org.cn/)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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