A 12-week Randomised, Double-blind, Parallel-group Study to Evaluate the Anti-inflammatory Effects of ADOAIR® 50/250mcg Twice Daily Compared With Placebo Twice Daily in Japanese Subjects With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change From Baseline in Neutrophil Count in Induced Sputum at Week 12
研究概览
简要总结
The study will be conducted in a respiratory specialist institute in Japan, with standardized techniques and data assurance checks to optimize data quality. The licensed dosage and administration of Adoair in Japan will be applied in this study. Each subject will receive treatment options in a randomized blinded fashion. Subjects will be randomized following a 4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo twice daily for 12 weeks.
详细描述
This is a randomised, double-blind, placebo-controlled, two-arm, parallel-group, 12-week-treatment study in Japanese patients with COPD.
At Visit 1, patients confirmed to be fulfilling all the inclusion criteria and not meeting any of the exclusion criteria will start the 4-week run-in period. During the entire study period, including the run-in period, the only drug allowed to use in addition to the study drug will be oxitropium (short-acting anticholinergic drug) as relief medication. At the end of the run-in period (Visit 2), subjects eligible for randomisation will be evenly randomised to one of the following two treatment groups and start the 12-week treatment period.
- ADOAIR®250 one inhalation twice daily from the DISKUS inhaler
- Placebo one inhalation twice daily from the DISKUS inhaler
Study completers will be defined as subjects who have completed all examinations, assessments, and study procedures in the study period, including the run-in period and the follow-up period. At completion/discontinuation of the treatment period, subjects will be switched to appropriate COPD treatment at the discretion of the investigator (or subinvestigator).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese (male or female) outpatients aged 40-80 years inclusive at Visit 1 (Female patients may be enrolled only if they are not of child-bearing potential, or are of child-bearing potential who agree to properly use protocol-specified contraceptive measures. )
- •Have a diagnosis of COPD (defined as per the COPD guideline)
- •Have a FEV1/FVC ratio < 0.70 at 15-60 minutes following use of SALTANOL® INHALER
- •Have a FEV1 of >= 40% to < 80% of the predicted normal value at 15-60 minutes following use of SALTANOL® INHALER
- •Current or ex-smokers with a smoking history of at least 10 pack-years
- •Able to use the DISKUS inhaler and the short-acting inhaled anticholinergic drug
- •Capable of providing written voluntary consent to participate in the study
排除标准
- •Diagnosed by the investigator (or subinvestigator) as having bronchial asthma
- •Have any respiratory disorder other than COPD (e.g., lung cancer, sarcoidosis, tuberculosis [including old tuberculosis], pulmonary fibrosis)
- •Have a chest X-ray (or CT scan) indicating a diagnosis other than COPD that might interfere with assessments in the study (This must be assessed using last imaging study performed within 6 months prior to Visit 1; or, a chest X-ray must be obtained at Visit 1.)
- •Have chronic respiratory failure
- •Have undergone lung volume reduction and/or lung transplant
- •Have had a COPD exacerbation or respiratory infection requiring systemic corticosteroid or microbial therapy or hospitalisation, within 6 weeks prior to Visit 1
- •Have used inhaled corticosteroids and systemic corticosteroids within 4 weeks prior to Visit 1
- •Have used long-acting β2 agonists (inhaled or patch) within 2 weeks prior to Visit 1
- •Are unable to stop their short-acting β2 agonist therapy at Visit 1 (During the study participation, oxitropium bromide (TERSIGAN) will be used as relief medication.)
- •Receiving long-term oxygen therapy with oxygen use for more than 12 hours per day
- •Have a concurrent serious or uncontrolled disease that might interfere with assessments in the study (including psychiatric disease, unstable liver disease, and heart disease)
- •Have a QTc > 450 msec (or > 480 msec in patients with bundle branch block) at Visit 1 (based on average QTc from three consecutive cardiac cycles on ECG)
- •Have participated in another study and received any other study drug within 4 weeks prior to Visit 1
- •Diagnosed by the investigator (or subinvestigator) as having drug or alcohol dependence
- •Have known or suspected hypersensitivity to bronchodilators, inhaled corticosteroid, or lactose
- •Have known α1 antitrypsin deficiency
- •Previously enrolled in this study
- •Judged by the investigator (or subinvestigator) to be inappropriate to participate in this study
研究组 & 干预措施
ADOAIR250
ADOAIR 250mcg inhalations, twice daily, from week0 - 12
干预措施: ADOAIR250 (Drug)
Placebo
Placebo inhalation, twice daily, from week0 -12
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Neutrophil Count in Induced Sputum at Week 12
时间窗: Baseline and Week 12
Induced sputum samples were collected at Baseline and at Week 12. The neutrophil count in induced sputum was measured with the use of a cytological specimen of inflammatory cells in the induced sputum. Change from Baseline in neutrophil count was calculated as the Week 12 value minus the Baseline value (percentage of neutrophil of total cells in induced sputum at Week 12 minus the Baseline value).
次要结局
- Change From Baseline in Interferon (INF)-Gamma-positive Cells and Perforin-positive Cells in Sputum at Week 12(Baseline and Week 12)
- Change From Baseline in All Inflammatory Cell Count in Induced Sputum at Week 12(Baseline and Week 12)
- Change From Baseline in Interleukin (IL)-8 Levels in Sputum Supernatant at Week 12(Baseline and Week 12)
- Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Levels in Sputum Supernatant at Week 12(Baseline and Week 12)
- Change From Baseline in Myeloperoxidase (MPO) and Pulmonary Surfactant Protein (SP)-D Levels in Sputum Supernatant at Week 12(Baseline and Week 12)
- Change From Baseline in IL-6 and IL-8 Levels in Serum at Week 12(Baseline and Week 12)
- Change From Baseline in hsCRP, SP-D, and Clara Cell Protein 16 (CC 16) Levels in Serum at Week 12(Baseline and Week 12)
- Change From Baseline in Fibrinogen Levels in Serum at Week 12(Baseline and Week 12)
- Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Week 12(Baseline and Week 12)
- Change From Baseline in the COPD Assessment Test (CAT) Question 1 Score at Week 12(Baseline and Week 12)
- Change From Baseline in the COPD Assessment Test (CAT) Question 2 Score at Week 12(Baseline and Week 12)
- Change From Baseline in the COPD Assessment Test (CAT) Question 3 Score at Week 12(Baseline and Week 12)
- Change From Baseline in the COPD Assessment Test (CAT) Question 4 Score at Week 12(Baseline and Week 12)
- Change From Baseline in the COPD Assessment Test (CAT) Question 5 Score at Week 12(Baseline and Week 12)
- Change From Baseline in the COPD Assessment Test (CAT) Question 6 Score at Week 12(Baseline and Week 12)
- Change From Baseline in the COPD Assessment Test (CAT) Question 7 Score at Week 12(Baseline and Week 12)
- Change From Baseline in the COPD Assessment Test (CAT) Question 8 Score at Week 12(Baseline and Week 12)
- Change From Baseline in the COPD Assessment Test (CAT) Total Score at Week 12(Baseline and Week 12)
- Number of Participants Who Experienced the Indicated Number of COPD Exacerbations During the Treatment Period(From Baseline up to Week 12)