NCT02268396已完成3 期
An Open-Label, Multi-Center, Dose Indicator Study of Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) in Adult Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count
研究概览
简要总结
This is an open-label, multi-center study to evaluate the accuracy, reliability and functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Give their signed written informed consent to participate.
- •Are at least 40 years of age and no older than 80 at Visit
- •A female of non-child bearing potential or child bearing potential, has a negative serum pregnancy test, and agrees to approved contraceptive methods.
- •COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society(ATS)/European Respiratory Society (ERS).
- •Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
- •FEV1/FVC ratio of <0.
- •Post-bronchodilator FEV1 must be ≥ 30% and <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations, and must also be greater than or equal to 750 mL.
- •Subject is willing and, in the opinion of the Investigator, able to adjust current COPD therapy as required by the protocol.
排除标准
- •Pregnancy, nursing females or subjects trying to conceive.
- •Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study.
- •Current primary diagnosis of asthma.
- •History of ECG abnormalities.
- •Poorly controlled or worsening COPD prior to Screening or during the Screening Period.
- •Clinically significant bladder neck obstruction or urinary retention.
- •Male subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening.
- •Cancer that has not been in complete remission for at least five years.
- •Inadequately treated glaucoma.
- •History of allergic reaction or hypersensitivity to any component of the formulations used in this study.
研究组 & 干预措施
Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler
Experimental
Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler (GFF MDI), PT003
干预措施: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler (Drug)
结局指标
主要结局
Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count
时间窗: Over the life of the canister/120 puffs - up to 4 weeks
Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit: ITT Population
次要结局
- Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit(Over the life of the canister/120 puffs - up to 4 weeks)
- Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit(Over the life of the canister/120 puffs - up to 4 weeks)
- Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit.(Over the life of the canister/120 puffs - up to 4 weeks)
- Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount)(Over the life of the canister/120 puffs - up to 4 weeks)
- Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count(Over the life of the canister/120 puffs - up to 4 weeks)
研究者
研究点 (1)
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