NCT00676052已完成2 期
Multicentre Dose Ranging Study for Once Daily GSK233705 in COPD
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 576
- 试验地点
- 1
- 主要终点
- Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with placebo in subjects with COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A signed and dated written informed consent prior to study participation.
- •Male or female adults.
- •A female is eligible to enter and participate in this study if she is of:
- •non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is post-menopausal; or child-bearing potential, has a negative pregnancy test at Visit 1/Visit 1A, and agrees to one of the protocol-specified acceptable contraceptive methods used consistently and correctly (i.e. according to the approved product label and the instructions of the physician for the duration of the study - Screening through follow-up contact)
- •40 to 80 years of age at Visit 1
- •An established clinical history of COPD
- •Current or previous cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years
- •A post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 and a post-albuterol/salbutamol FEV1 of ≥35 and ≤70% of predicted normal values
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •Women who are pregnant or lactating.
- •A current diagnosis of asthma.
- •Known respiratory disorders other than COPD including but not limited to α-1 antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease.
- •Any previous lung resection surgery (e.g., lung volume reduction surgery or lobectomy)
- •Clinically significant Chest X-ray or computed tomography (CT) scan abnormalities within 6 months prior to Visit 1 that are not believed to be due to COPD.
- •Use of oral corticosteroids or antibiotics for COPD within 6 weeks prior to Visit
- •Hospitalization for COPD or pneumonia within 3 months prior to Visit
- •Use of antibiotics for a lower respiratory tract infection within 30 days prior to Visit
- •Clinically significant and uncontrolled cardiovascular, neurological, psychiatric, renal, gastro-intestinal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities.
- •An abnormal and clinically significant 12-lead electrocardiogram (ECG) that results in active medical problem.
- •Positive for Hepatitis B or Hepatitis C at Visit
- •A current malignancy or previous history of cancer in remission for <5 years prior to Visit 1
- •A history of allergy or hypersensitivity to ipratropium, tiotropium, or atropine and any of their derivatives, lactose/milk protein or magnesium stearate.
- •Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the study investigator would prevent use of an inhaled anticholingeric.
- •Medically unable to withhold albuterol/salbutamol for 6 hours prior to spirometry testing at each study visit or to withhold ipratropium (if applicable) for the 6-hour period prior to the first 3 study visits (ipratropium cannot be used after Visit 3).
- •Additional Medications: Unable to stop using certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator will discuss the specific medications)
- •Use of inhaled corticosteroids at a dose greater than 1000 mcg/day of fluticasone propionate or equivalent within 30 days prior to Visit
- •Use of long-term oxygen therapy (LTOT) or supplemental oxygen required for greater than 12 hours a day. Oxygen use as needed is not exclusionary.
- •Clinically significant sleep apnea that requires continuous positive airway pressure (CPAP)
- •Use of regular nebulized therapy
- •Use of nocturnal positive pressure or non-invasive positive pressure ventilation (NIPPV)
- •Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit
- •An investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the above who is involved in this study
- •History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse in the two years prior to Visit 1 (including drug and alcohol), or other conditions, which will limit the validity of informed consent to participate in the study.
- •Use of GSK233705B in previous studies.
研究组 & 干预措施
Arm 1
Experimental
GSK233705 12.5mcg
干预措施: GSK233705 12.5mcg (Drug)
Arm 2
Experimental
GSK233705 25mcg
干预措施: GSK233705 25mcg (Drug)
Arm 3
Experimental
GSK233705 50mcg
干预措施: GSK233705 50mcg (Drug)
Arm 4
Experimental
GSK233705 100mcg
干预措施: GSK233705 100mcg (Drug)
Arm 5
Experimental
GSK233705 200mcg
干预措施: GSK233705 200mcg (Drug)
Arm 6
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
时间窗: Baseline (pre-dose Day 1) and Day 29
The trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 28. The Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose \[time 0\] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.
次要结局
- Change From Baseline in Weighted Mean for 0 to 24 Hours Serial FEV1 on Day 1 to 2 and 28 to 29(Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29)
- Change From Baseline in Weighted Mean for 0 to 24 Hours Forced Vital Capacity (FVC) on Day 1 to 2 and 28 to 29(Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29)
- Change From Baseline in Clinic Visit Trough FVC on Day 29(Baseline (pre-dose Day 1) and Day 29)
研究者
研究点 (1)
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