Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma
2017년 10월 9일 업데이트: GlaxoSmithKline
A Randomized, Double-blind, Double-dummy, Parallel-group, Placebo Controlled (on Inhaled Corticosteroid Medication), Multicenter Study to Evaluate the Efficacy and Safety of Vilanterol Inhalation Powder (GW642444) and Salmeterol, Compared With Placebo in the Treatment of Persistent Asthma in Adults and Adolescents Uncontrolled on Inhaled Corticosteroids
The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
348
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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Bayern
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Gauting, Bayern, 독일, 82131
- GSK Investigational Site
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Hessen
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Frankfurt, Hessen, 독일, 60596
- GSK Investigational Site
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, 독일, 55131
- GSK Investigational Site
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Schleswig-Holstein
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Grosshansdorf, Schleswig-Holstein, 독일, 22927
- GSK Investigational Site
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California
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Huntington Beach, California, 미국, 92647
- GSK Investigational Site
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Florida
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Orlando, Florida, 미국, 32822
- GSK Investigational Site
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Tallahassee, Florida, 미국, 32308
- GSK Investigational Site
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Georgia
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Lawrenceville, Georgia, 미국, 30046
- GSK Investigational Site
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New Jersey
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Skillman, New Jersey, 미국, 08558
- GSK Investigational Site
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North Carolina
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Raleigh, North Carolina, 미국, 27607
- GSK Investigational Site
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Ohio
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Cincinnati, Ohio, 미국, 45231
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73103
- GSK Investigational Site
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South Carolina
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Chester, South Carolina, 미국, 29706
- GSK Investigational Site
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Clinton, South Carolina, 미국, 29325
- GSK Investigational Site
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Orangeburg, South Carolina, 미국, 29118
- GSK Investigational Site
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Dnipropetrovsk, 우크라이나, 49074
- GSK Investigational Site
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Dnipropetrovsk, 우크라이나, 49027
- GSK Investigational Site
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Donetsk, 우크라이나, 83099
- GSK Investigational Site
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Ivano-Frankivsk, 우크라이나, 76018
- GSK Investigational Site
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Kharkiv, 우크라이나, 61124
- GSK Investigational Site
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Kharkiv, 우크라이나, 61037
- GSK Investigational Site
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Kyiv, 우크라이나, 03680
- GSK Investigational Site
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Simferopol, 우크라이나, 95043
- GSK Investigational Site
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Yalta, 우크라이나, 98603
- GSK Investigational Site
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Lima, 페루, Lima 27
- GSK Investigational Site
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Lima
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Callao, Lima, 페루, Callao 2
- GSK Investigational Site
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Lima 27, Lima, 페루, Lima 27
- GSK Investigational Site
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San Isidro, Lima, 페루, Lima 27
- GSK Investigational Site
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San Miguel, Lima, 페루, Lima 32
- GSK Investigational Site
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Chrzanow, 폴란드, 32-500
- GSK Investigational Site
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Krakow, 폴란드, 31-024
- GSK Investigational Site
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Krakow, 폴란드, 31-455
- GSK Investigational Site
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Krakow, 폴란드, 30-901
- GSK Investigational Site
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Lublin, 폴란드, 20-552
- GSK Investigational Site
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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 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Outpatient at least 12 years of age
- Both genders; females of childbearing potential must be willing to use birth control method
- Clinical diagnosis of asthma for ≥12 weeks
- Best pre-bronchodilator FEV1 of 40%-90% predicted
- Reversibility of FEV1 of at least 12% and 200mls
- Current asthma therapy that include an inhaled corticosteroid for at least 12 weeks prior to 1st visit
- Ability to use replace current short-acting rescue treatment with albuterol and ability to withhold albuterol use for at least 6 hours prior to study visits
Exclusion Criteria:
- History of life-threatening asthma
- Respiratory infection within last 4 weeks leading to change in asthma management
- Asthma exacerbation within last 3 months
- Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drugs' excipients, or medications related to study drugs
- Taking another investigational medication or medication prohibited for use during the study.
- Previous participation in a vilanterol (GW642444) study
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Vilanterol
Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
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Vilanterol inhalation powder inhaled orally once daily for 12 weeks
Placebo inhalation powder inhaled orally twice daily for 12 weeks
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활성 비교기: Salmeterol
Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks
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Salmeterol inhalation powder inhaled orally twice daily for 12 weeks
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
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위약 비교기: Placebo
Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
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Placebo inhalation powder inhaled orally twice daily for 12 weeks
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12
기간: Baseline and Week 12
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FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second.
The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12.
The Baseline value was the Day 1 pre-dose FEV1 measurement.
Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value.
Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.
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Baseline and Week 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period
기간: Baseline and Weeks 1-12
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The time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period.
The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization).
Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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Baseline and Weeks 1-12
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Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period
기간: Baseline and Weeks 1-12
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Participants who were symptom free for 24-hour periods during the12-week treatment period were assessed.
The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization).
Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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Baseline and Weeks 1-12
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Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
기간: Baseline and Week 12
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FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second.
The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12).
The Baseline value was the Day 1 pre-dose FEV1 measurement.
Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value.
Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.
Analysis was performed separately for each planned time point.
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Baseline and Week 12
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Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) PM (Evening) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period
기간: Baseline and Weeks 1-12
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PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated.
Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug.
The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization.
Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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Baseline and Weeks 1-12
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Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period
기간: Baseline and Weeks 1-12
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PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated.
Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug.
The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization.
Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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Baseline and Weeks 1-12
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Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
기간: Day 1 and Week 12
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The number of participants with a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a >=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points.
Participants who did not achieve a >=12% and >=200 mL increase from Baseline in FEV1 over this time period were considered censored.
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Day 1 and Week 12
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Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
기간: Week 4 and Week 12
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At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often.
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Week 4 and Week 12
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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
2010년 9월 1일
기본 완료 (실제)
2011년 8월 1일
연구 완료 (실제)
2011년 8월 26일
연구 등록 날짜
최초 제출
2010년 7월 15일
QC 기준을 충족하는 최초 제출
2010년 8월 12일
처음 게시됨 (추정)
2010년 8월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 11월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 10월 9일
마지막으로 확인됨
2017년 10월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 112060
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
연구 데이터/문서
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임상 연구 보고서
정보 식별자: 112060정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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주석이 달린 사례 보고서 양식
정보 식별자: 112060정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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정보에 입각한 동의서
정보 식별자: 112060정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: 112060정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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개별 참가자 데이터 세트
정보 식별자: 112060정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: 112060정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: 112060정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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. .
Vilanterol에 대한 임상 시험
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GlaxoSmithKline완전한천식미국, 아르헨티나, 독일, 대한민국, 루마니아, 러시아 연방, 스페인, 네덜란드, 멕시코, 브라질, 칠레, 체코