- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00702910
A Study to Investigate the Effect of Inhaling Single Doses of Different Formulations of GW642444M in Asthmatic Patients
2017년 8월 8일 업데이트: GlaxoSmithKline
A Randomised, Single-dose, Double-blind, Placebo-controlled, 5-way Crossover Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With and Without Magnesium Stearate in Asthmatic Patients
This study will involve the use of a new medicine called GW642444 being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
The purpose of the study is to see how safe and how well tolerated the study drug is when inhaled in two different formulations as a fine powder by asthmatic patients.
In addition, the study is designed to examine the effect of the study drug on the lungs, how the study drug affects parts of the body other than the lungs and to see how the body affects the study drug when it is given in single doses.
연구 개요
연구 유형
중재적
등록 (실제)
24
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
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
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Subjects with a documented history of persistent asthma, with the exclusion of other significant pulmonary diseases (e.g. chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia).
- Male subjects or female subjects aged between 18 to 70 years.
A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (< 140 pmol/L) is confirmatory.
- Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 2 days post last-dose.
- Subjects who are current non-smokers, who have not used any inhaled tobacco products (snuff is permitted) in the 12 month period preceding the screening visit and who have a pack history of ≤ 10 pack years.
- Subjects with clinically stable, mild to moderate persistent asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 ≥ 60 % predicted as defined in the GINA guidelines [Global Initiative for Asthma (GINA), 2006] (having abstained from bronchodilators for the required period). Predicted values are based on the ECCS 1993 normal ranges.
- Body weight ≥ 50 kg and body mass index (BMI) within the range 19 - 29.9 kg/m2
- During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of ≥ 12.0% over baseline and an absolute change of ≥ 200 mL within 30 minutes following a single 400 mcg salbutamol dose.
- ECG criteria as per protocol
- Subjects who are currently taking ICS at a total daily dose of 200 to 500 mcg of FP or equivalent ICS.
- Subjects who are able and willing to give written informed consent to take part in the study.
Exclusion Criteria:
- Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, which may affect the safety of the subject or outcome of this study.
- A screening Holter ECG tracing that reveals clinically concerning arrhythmias.
- Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit
- Subjects with a history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with either respiratory arrest or hypoxic seizures.
- Asthma exacerbations requiring treatment with oral corticosteroids: any exacerbations within 3 months of the screening visit or two or more exacerbations within 6 months of the screening visit or admittance to hospital for an asthma exacerbation within 1 year of the screening visit.
- Subjects classified as suffering from severe asthma as defined by the ATS guidelines
- Subjects who have taken high doses of an inhaled corticosteroid (> 500 mcg FP/day or equivalent) within 8 weeks of the screening visit or oral steroids within 12 weeks of the screening visit.
- Subjects who have changed their inhaled corticosteroid treatment within the last 6 weeks before screening or can be expected to do so during the study.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four NCE's within 12 months prior to the first dosing day
- Any adverse reaction including immediate or delayed hypersensitivity to any β2 agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of GW642444 inhalation powder (e.g., lactose, milk protein, magnesium stearate).
- Subjects with a positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody or HIV result (if tested as per site SOPs) within 3 months of the start of the study.
- Neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol requirements, including compliance.
- Abuse of alcohol is defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females).
- 1 unit is equivalent to a half pint (220 mL) of beer or 1 measure (25 mL) of spirits or 1 glass (125 mL) of wine.
- The subject has a positive pre-study urine drug test screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- The subject has a positive pre-study alcohol or smoking breath or urinary test.
- Where participation in the study would result in donation of blood in excess of 500 mL within a 56 day period.
- Subjects with clinically relevant findings on laboratory safety tests.
- Subjects with laboratory values outside the reference range may be included if the Investigator and medical monitor agree that these findings would not put the subject at risk or interfere with the objectives of the study.
- Subjects with known hypersensitivity to salbutamol or any ingredient in this preparation
- Subjects who have taken P-gp inhibitors and CYP 450 3A4 inhibitors (e.g. Ketoconazole) within 6 weeks or theophyllines within 2 weeks of the screening visit.
- Inability to use the novel dry powder inhaler.
- Pregnant females as determined by positive hCG (serum or urine) test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
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: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: GW642444M/lactose
GW642444M/lactose 6.25, 25 and 100 microgram, single inhaled dose for two days treatment in each treatment sequence (crossover design)
|
비교기
investigational drug or placebo
다른 이름들:
Magnesium Stearate
|
실험적: GW642444M/MgSt
GW642444M/MgSt 6.25, 25 and 100 microgram, single inhaled dose for two days treatment in each treatment sequence (crossover design)
|
비교기
investigational drug or placebo
다른 이름들:
Magnesium Stearate
|
위약 비교기: Placebo
Placebo containing lactose, single inhaled dose for two days treatment in each treatment sequence (crossover design)
|
비교기
investigational drug or placebo
다른 이름들:
Magnesium Stearate
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Mean change from baseline (pre-dose) FEV1 in trough (mean of the FEV1 values obtained 23 and 24 hours after dosing) FEV1
기간: on going
|
on going
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Mean change from baseline (pre-dose) in FEV1 (i.e. derive separate responses for each FEV1 obtained over 24 hours after dosing).
기간: on going
|
on going
|
General safety and tolerability, including adverse events, laboratory safety tests (haematology, clinical chemistry and urinalysis), vital signs and, 12-lead ECG.
기간: on going
|
on going
|
Weighted mean and maximum value (0 - 4 h) QTc(B)
기간: on going
|
on going
|
Weighted mean and maximum value (0 - 4 h) QTc(F)
기간: on going
|
on going
|
Weighted mean and maximum value (0 - 4 h) supine heart rate
기간: on going
|
on going
|
Weighted mean and maximum value (0 - 4 h) supine systolic blood pressure
기간: on going
|
on going
|
Weighted mean and minimum value (0 - 4 h) supine diastolic blood pressure
기간: on going
|
on going
|
Weighted mean and maximum value glucose (0 - 4 h)
기간: on going
|
on going
|
Weighted mean and minimum value potassium (0 - 4 h)
기간: on going
|
on going
|
Single dose derived plasma pharmacokinetic parameters (AUC(0-t), Cmax, tmax) for GW642444 and GI179710 (triphenylacetate counterion)
기간: on going
|
on going
|
Estimate GW642444 concentration (Cmax) -systemic pharmacodynamic relationship for PD parameters, including heart rate, potassium & glucose levels
기간: on going
|
on going
|
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 (실제)
2008년 4월 27일
기본 완료 (실제)
2008년 10월 4일
연구 완료 (실제)
2008년 10월 4일
연구 등록 날짜
최초 제출
2008년 6월 18일
QC 기준을 충족하는 최초 제출
2008년 6월 19일
처음 게시됨 (추정)
2008년 6월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 8월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 8월 8일
마지막으로 확인됨
2017년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- B2C111401
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
-
통계 분석 계획
정보 식별자: B2C111401정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
데이터 세트 사양
정보 식별자: B2C111401정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
개별 참가자 데이터 세트
정보 식별자: B2C111401정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
임상 연구 보고서
정보 식별자: B2C111401정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
연구 프로토콜
정보 식별자: B2C111401정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
주석이 달린 사례 보고서 양식
정보 식별자: B2C111401정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
정보에 입각한 동의서
정보 식별자: B2C111401정보 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. .
위약에 대한 임상 시험
-
AJU Pharm Co., Ltd.OM Pharma SA모병
-
University Hospital, Strasbourg, France모집하지 않고 적극적으로