Comparison of Efficacy and Safety of Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Treatment Administered Via Capsair and Original Product Seretide Diskus 500 mcg Inhalation Powder Treatment in Patients With Moderate-severe Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Mean maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1)
研究概览
简要总结
The aim of the current study is to compare the efficacy and safety of Salmeterol/Fluticasone 50/500 mcg Inhalation Powder treatment administered via Capsair twice daily and original product Seretide Diskus 500 mcg Inhalation Powder treatment twice daily in patients with moderate-severe COPD.
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits of 11-weeks study period.
详细描述
The aim of the current study is to compare the efficacy and safety of Salmeterol/Fluticasone 50/500 mcg Inhalation Powder treatment administered via Capsair twice daily and original product Seretide Diskus 500 mcg Inhalation Powder treatment twice daily in patients with moderate-severe COPD.
Patients who met all the inclusion criteria will enter a 1-week run-in period with the length determine by the specific medication, during which their usual treatment will be stopped and they will receive salbutamol as required.
Following run-in period, patients will be randomly assigned to receive Salmeterol/Fluticasone 50/500 mcg as dry powder capsule for inhalation by Capsair or Salmeterol/Fluticasone 50/500 mcg as dry powder for inhalation by Diskus twice daily for 8-weeks treatment period.
Patients will be evaluated at 6 consecutive visits: baseline (enrollment), screening, treatment (treatment initiation, after 4 and 8 weeks of treatment) and after treatment (will carry out by telephone two weeks following the last dose of study medication).
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits of 11-weeks study period.
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
- None
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥40 years with moderate-severe COPD diagnosis according to the GOLD (The Global Initiative for Chronic Obstructive Lung Disease) strategy
- •Patients who have symptomatic stable moderate to severe COPD diagnosis with post-bronchodilator FEV1/ Forced Vital Capacity (FVC) <0.70, and FEV1 ≥30% and <80% of predicted normal value at screening visit
- •Current smokers or ex-smokers with a smoking history of at least 10 pack-years
- •Patients who have no exacerbation within last 4 weeks
- •Females patients with childbearing potential using effective birth control method
- •Patients whose medication unchanged within least 4 weeks
- •Patients who has a capability of communicate with investigator
- •Patients who accept to comply with the requirements of the protocol
- •Patients who signed written informed consent prior to participation
排除标准
- •History of hypersensitivity to long acting beta-2 agonists or corticosteroids
- •History of asthma or significant chronic respiratory diseases (e.g., interstitial lung diseases, significant bronchiectasis, etc.)
- •Patients who had COPD exacerbation or lower respiratory track infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to screening visit or during run-in period
- •Use of immunosupresants or systemic corticosteroids within least 4 weeks
- •History of severe cardiac arrhythmia or myocardial infarction within less than 6 months
- •Significant or uncontrolled disease that may preclude participant from participating in the study
- •Diognosis of cancer
- •History of lung volume reduction operation
- •Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period
- •Women patients who are pregnant or nursing
- •History of allergic rhinitis and atopy
研究组 & 干预措施
Salmeterol/Fluticasone Capsair®
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks
干预措施: Salmeterol/Fluticasone Capsair® (Drug)
Salmeterol/Fluticasone Diskus®
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for 8 weeks
干预措施: Salmeterol/Fluticasone Diskus® (Drug)
结局指标
主要结局
Mean maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1)
时间窗: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FVC (AUC0-12) response
时间窗: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Comparison of FEV1 values at pre-dose and 2 hours post-dose
时间窗: 8-weeks treatment period after randomization
Spirometric measurement will be performed at pre-dose and 2 hours post-dose
FEV1 (AUC12-24) response
时间窗: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FVC (AUC0-24) response
时间窗: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FEV1 (AUC0-12) response [AUC: area under the curve; response defined as change from baseline]
时间窗: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Mean percentage (%) change from baseline in
时间窗: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FVC (AUC12-24) response
时间窗: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FEV1 (AUC0-24) response
时间窗: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
次要结局
- Time to onset of bronchodilator effect and maximum effect(8-weeks treatment period after randomization)
- Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) after 8-weeks treatment(8-weeks treatment period after randomization)
- Adverse events, serious adverse events and all cause mortality.(10 weeks after randomization)
- Mean change from baseline in transition dyspnea index (TDI) after 8-weeks treatment(8-weeks treatment period after randomization)
- Frequency of rescue medicine (salbutamol) used(8-weeks treatment period after randomization)
- Mean change from baseline in symptom severity and frequency (mean change from baseline in CAT score)(8-weeks treatment period after randomization)