NCT04446637撤回3 期
Comparison of Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination Delivered Via pMDI and Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol in Patients With Stable Moderate-Severe-Very Severe Chronic Obstructive Pulmonary Disease (COPD).
Neutec Ar-Ge San ve Tic A.Ş0 个研究点开始时间: 2021年9月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- FEV1 AUC (0-8h)
研究概览
简要总结
The purpose of this study is to compare acute bronchodilator effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI and Salbutamol 100 mcg Inhaler (2 inhalations) plus Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination in Patients with stable moderate-severe-very severe COPD.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients aged ≥40 years diagnosed with symptomathic stable moderate-severe-very severe COPD: post-bronchodilator FEV1/FVC <70% predicted and a post-bronchodilator FEV1 <80% predicted at screen visit.
- •Group B COPD CAT: ≥10 or mMRC: ≥ 2 Exacerbation: 0-1 (not leading to hospital admission)
- •Group C COPD CAT: <10 or mMRC: 0-1 Exacerbation: ≥2 (not leading to hospital admission) or ≥1 (leading to hospital admission)
- •Group D COPD CAT: ≥10 or mMRC: ≥ 2 Exacerbation: ≥2 (not leading to hospital admission) or ≥1 (leading to hospital admission)
- •Current or ex-smokers with a smoking history of at least 10 pack-years
- •Patients who have no exacerbation within the last 4 weeks
- •Female patients who use effective contraception
- •Patients who have a capability to communicate with investigator
- •Patients who accept to comply with the protocol
- •Patients who sign written informed consent form
排除标准
- •History of hypersensitive to anticholinergics or SABAs
- •History of COPD exacerbation or lower respiratory track infection that required treatment with antibiotic, oral or parenteral corticosteroid within the last 4 weeks prior the screening visit or during the run-in/wash-out period or history of respiratory tract infection that required treatment with antibiotic within the last 14 days prior the screening visit.
- •Hospitalization due to COPD or pneumonia within the last 3 mounts prior the screening visit
- •Use of oral corticosteroid at unstable dosages (i.e. <6 weeks on a stable dose of prednisone)
- •SGOT (serum glutamic oxaloacetic transaminase) >80 IU/L, SGPT (serum glutamic pyruvic transaminase) >80 IU/L, bilirubin >2.0 mg/dL or creatinine >2.0 mg/dL
- •History of asthma, significant chronic respiratory diseases (i.e., significant bronchiectasis, interstitial lung diseases, etc.) other than COPD or presence of disease that may be serious and/or potentially affect results of the study.
- •Initiation of an inhaled steroid or change in dose within <6 weeks prior the screening visit
- •Use of beta-blocker, monoamine oxidase (MAO) inhibitor or tricyclic antidepressant within the last 30 days prior the screening visit
- •Recent (within ≤1 year prior the screening visit) history of heart attack, heart failure, acute ischemic heart disease or presence of serious cardiac arrhythmia requiring drug treatment
- •Regularly use of daytime CPAP (continuous positive airway measure) oxygen therapy for longer than 1 hour per day
- •Initiation of pulmonary rehabilitation within the 3 months prior the screening visit
- •History of lung volume reduction surgery
- •Drug or alcohol abuse
- •Presence of active tuberculosis
- •History of atopy or allergic rhinitis
- •History of cancer within the last 5 years
- •Attenuated live virus vaccination within the last 2 weeks prior the screening visit or during the run-in/wash-out period
- •Pregnancy or lactation
- •Presence of known symptomatic prostatic hypertrophy requiring treatment
- •Presence of known narrow-angle glaucoma requiring treatment
- •Currently participating in another clinical trial or treatment with another investigational study drug within the last month or 6-half-lives, whichever is longer.
研究组 & 干预措施
Ipratropium/Levosalbutamol
Experimental
Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI
干预措施: Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI (Drug)
Salbutamol + Ipratropium
Active Comparator
Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI
干预措施: Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI (Drug)
结局指标
主要结局
FEV1 AUC (0-8h)
时间窗: Baseline, 0 to 8 hours post-dose at treatment day
Change From Baseline in Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 0-8h. Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
次要结局
- FVC AUC (6-8h)(Baseline, 6 to 8 hours post-dose at treatment day)
- FEV1 AUC (0-4h)(Baseline, 0 to 4 hours post-dose at treatment day)
- FEV1 AUC (4-6h)(Baseline, 4 to 6 hours post-dose at treatment day)
- FEV1 AUC (6-8h)(Baseline, 6 to 8 hours post-dose at treatment day)
- FVC AUC (0-4h)(Baseline, 0 to 4 hours post-dose at treatment day)
- FVC AUC (4-6h)(Baseline, 4 to 6 hours post-dose at treatment day)
- FVC AUC (0-8h)(Baseline, 0 to 8 hours post-dose at treatment day)
- Change From Baseline in FEV1 and FVC within the first 15 minutes after dosing(Baseline, 0 to 15 minutes post-dose at treatment day)
- Mean Maximum Change From Baseline in FEV1 and FVC within the first 2 hours after dosing(Baseline, 0 to 2 hours post-dose at treatment day)
- Mean Maximum Change From Baseline in FEV1 and FVC over a period of 8 hours(Baseline, 0 to 8 hours post-dose at treatment day)
- The Time to Onset of Bronchodilator Response(Baseline, 0 to 8 hours post-dose at treatment day)
- The Time to Maximum Effect(Baseline, 0 to 8 hours post-dose at treatment day)
- Duration of Bronchodilator Response(Baseline, 0 to 8 hours post-dose at treatment day)
- Evaluation of Safety (physical examination, numbers of adverse reactions and abnormal laboratory values or ECG related to treatment)(Baseline, 0 to 24 hours post-dose)
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