A Randomized, Double-blind, Two Treatment, Two Period, Chronic Dosing (4 Weeks), Crossover, Multi-center Pilot Study to Evaluate the Effects of Budesonide/Glycopyrronium/Formoterol Fumarate and Glycopyrronium/Formoterol Fumarate on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Specific Image-based Airway Volume (siVaw)
研究概览
简要总结
This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.
详细描述
This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF), and Glycopyrronium/Formoterol Fumarate (GFF), on specific image based airway volumes and resistance in subjects with moderate to severe Chronic Obstructive Pulmonary Disease. In this study, airway dimension parameters will be calculated for each of the active compounds.
This imaging methodology will allow an assessment of the extent of airway changes using a triple combination of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and the dual combination Glycopyrronium/Formoterol Fumarate (GFF).
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
- Triple (Participant, Care Provider, 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
- •Subject must be 40 years to ≤80 years of age inclusive, at the time of signing the informed consent form at Visit
- •COPD Diagnosis: Subjects with an established clinical history of COPD
- •Screening clinical laboratory tests must be acceptable to the Investigator.
- •Screening ECG must be acceptable to the Investigator
- •Individual Compliance: Subjects must be willing to remain at the study center as required per protocol to complete all visit assessments
- •Patients should be on scheduled maintenance treatment with one or more inhaled bronchodilator therapies.
排除标准
- •As judged by the investigator, any evidence of significant diseases other than COPD, i.e., disease or condition which, in the investigator's opinion makes it undesirable for the subject to participate in the trial.
- •Spirometry Performance:
- •Subjects who cannot perform acceptable spirometry, i.e., meet ATS/ERS acceptability criteria.
- •Repeatability: Subjects who cannot perform technically acceptable spirometry in accordance with ATS repeatability criteria
- •Cancer: Subjects who have cancer that has not been in complete remission for at least five years.
- •Substance Abuse: Subjects, who in the opinion of the Investigator, significantly abuse alcohol or drugs
- •Subjects who in the opinion of the investigator are unable to abstain from prohibited medications including LABA/LAMAs/ICS
研究组 & 干预措施
BGF-GFF
Subject first treated with Budesonide/Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Glycopyrronium/Formoterol Fumarate
干预措施: GFF (Combination Product)
GFF-BGF
Subject first treated with Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Budesonide/Glycopyrronium/Formoterol Fumarate
干预措施: GFF (Combination Product)
BGF-GFF
Subject first treated with Budesonide/Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Glycopyrronium/Formoterol Fumarate
干预措施: BGF (Combination Product)
GFF-BGF
Subject first treated with Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Budesonide/Glycopyrronium/Formoterol Fumarate
干预措施: BGF (Combination Product)
结局指标
主要结局
Specific Image-based Airway Volume (siVaw)
时间窗: Baseline, Day 29
Specific image-based airway volume (SiVaw) measured in mL/L. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.
Specific Image-based Airway Resistance (siRaw)
时间窗: Baseline, Day 29
Specific image-based airway resistance (siRaw) measured in kPa∙s. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.
次要结局
- Image-based Airway Resistance (iRaw)(Baseline, 29 Days)
- Image-based Airway Volume (iVaw)(Baseline, Day 29)
- Forced Expiratory Volume in One Second (Post-dose FEV1).(Baseline 29 Days)
- Functional Residual Capacity (FRC)(Baseline, Day 29)