A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD: GOLDEN 6 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 10
- 主要终点
- Change From Baseline in Trough FEV1 at Treatment Visit Day 7 Compared to Placebo.
研究概览
简要总结
Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg 2x a day will be given as an active comparator.
详细描述
This is a randomized, six-way crossover study to determine the efficacy and dose-response profile of SUN101. The study population will consist of subjects 40 to 65 years-old (inclusive), with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg bid will be given as an active comparator. The study will be double-blind for SUN-101 and placebo and will be open-label for aclidinium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 40 to 65 years-old, inclusive.
- •A clinical diagnosis of moderate to severe COPD according to the GOLD 2011 guidelines.
- •Current smokers or ex-smokers with at least 10 pack year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
- •Post bronchodilator (following inhalation of ipratropium bromide) FEV1 ≥ 40% and ≤ 70% of predicted normal during Screening.
- •Post bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio ≤ 0.70 during Screening.
- •Post bronchodilator (following inhalation of ipratropium bromide) improvement in FEV1 ≥ 12% and ≥ 100 mL during Screening.
- •Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).
- •Female of child bearing potential (only) must have a negative serum pregnancy test at Screening and be neither breastfeeding nor intending to become pregnant during study participation. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study. Female subjects of child bearing potential must use an adequate method of birth control from Screening until 30 days after receiving study drug and use contraception in addition to their partners using a barrier method. Acceptable forms of contraception are as follows:
- •Abstinence
- •Barrier methods: condoms, diaphragms, cervical caps; with a spermicide foam, gel, film, cream or suppository;
- •Oral contraceptives
- •Non hormone containing intrauterine methods: intrauterine devices or systems.
- •Willing and able to remain at the study site for at least 24 hours at Day 7 of each Treatment Period.
- •Willing and able to attend all study visits and adhere to all study assessments/procedures.
- •Willing and able to provide written informed consent
排除标准
- •Current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
- •Current evidence or history of a clinically significant abnormality of cardiac rhythm and/or conduction including Holter monitoring prior to randomization.
- •Primary diagnosis of asthma.
- •History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin.
- •Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening.
- •Use of daily oxygen therapy > 10 hours per day.
- •Use of systemic steroids within 3 months prior to Screening.
- •Respiratory tract infection within 6 weeks prior to or during Screening.
- •History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
- •History of urinary retention or bladder neck obstruction type symptoms.
- •History of narrow angle glaucoma.
- •Prolonged QTcF interval (males > 450 msec and females >470 msec) during Screening, or history of long QT syndrome.
- •Recent history (previous 12 months) of excessive use or abuse of alcohol or narcotic/illegal drugs.
- •History of hypersensitivity or intolerance to aerosol medications, beta-2 agonists, or anticholinergics.
- •Participation in another investigational drug study where drug was received within 30 days prior to Screening, or current participation in another investigational drug trial.
- •Subject is a staff member of the clinical site or a relative of a clinical site staff member.
研究组 & 干预措施
SUN-101 50 mcg
SUN-101 50 mcg bid
干预措施: SUN-101 50 mcg (Drug)
Placebo
Placebo bid
干预措施: Placebo (Drug)
SUN-101 3 mcg
SUN-101 3 mcg bid
干预措施: SUN101 3 mcg (Drug)
SUN-101 6.25 mcg
SUN-101 6.25 mcg bid
干预措施: SUN-101 6.25 mcg (Drug)
SUN-101 12.5 mcg
SUN-101 12.5 mcg bid
干预措施: SUN-101 12.5 mcg (Drug)
Aclidinium 400 mcg
Aclidinium 400 mcg bid
干预措施: Aclidinium (Drug)
结局指标
主要结局
Change From Baseline in Trough FEV1 at Treatment Visit Day 7 Compared to Placebo.
时间窗: Baseline and Day 7
Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the 2 spirometry values collected at 23 hours 15 minutes, and 23 hours 45 minutes post-morning dose on Day 7 of each Treatment Period. The FEV1 values within 6 hours after the use of rescue medication were considered as missing. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period
次要结局
- Standardized Change From Baseline in FEV1 AUC(0-12hours)(Day 7)
- Number of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)(Over 7 days)
- Percentage of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)(Over 7 days)