NCT02424344已完成4 期
A Multiple Dose, Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Assess the Effect of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combination on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment
研究概览
简要总结
The present study is planned to evaluate the effect of the aclidinium bromide/formoterol fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in patients with moderate to severe COPD. Additionally, the effect of the behavioural intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both on the exercise endurance and the physical activity.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant, non-lactating females aged ≥
- •Patients with a clinical diagnosis of COPD according to GOLD guidelines 2014, with a post bronchodilator FEV1 ≥ 40% and < 80% of the predicted value and FEV1/FVC < 70% at Visit
- •Functional residual capacity (FRC) measured by body plethysmography at Visit 1 ≥ 120% of predicted value.
- •Patients with modified Medical Research Council dyspnea scale (mMRC) ≥ 2 at Visit
- •Current or former cigarette smokers with a smoking history of at least 10 pack-years at Visit 1
- •Patients willing to participate in the telecoaching program during the four last weeks and to enhance their physical activity
- •Patients who understand and are able to follow the study procedures, are cooperative and are willing to participate in the study as indicated by signing the informed consent.
排除标准
- •History or current diagnosis of asthma.
- •Any respiratory tract infection (including upper respiratory tract) or COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period.
- •Patients who have been hospitalised for an acute COPD exacerbation within 3 months prior to Visit 1 or during the run-in period.
- •Clinically significant respiratory conditions other than COPD.
- •Use of long-term oxygen therapy (≥ 15 hours/day).
- •Oxygen saturation ≤ 85% as measured by pulse oximetry during exercise testing at Visit 1, Visit 2 or Visit 3 prior to randomisation.
- •Patients with a Body Mass Index (BMI) ≥ 40kg/m
- •Patient who may need to start a pulmonary rehabilitation program during the study and/or who started/finished it within 3 months prior to Visit 1 or during the run-in period.
- •Patients with clinically significant cardiovascular conditions.
- •Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension.
- •Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.
- •Patients with clinically relevant abnormalities in the results of the blood pressure, ECG, or physical examination at Visit
- •Patients with any serious or uncontrolled physical or mental dysfunction that could place the patient at higher risk derived from his/her participation in the study or could confound the results
- •Patients with conditions other than COPD that may contribute to dyspnoea and exercise limitation or with contraindications to clinical exercise testing according to ATS recommendations for CPET
- •Patients with other relevant comorbidities that make the patient nor suitable to follow-up study procedures and/or could affect physical activity
- •Patients who cycled < 2 minutes or > 15 minutes during the constant work-rate exercise tests conducted at Visit 2 (Run-in Visit) or at Visit 3 even after adjustment of the work load.
- •Patients with history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
- •Patients for whom the use of anticholinergic drugs is contraindicated (acute urinary retention, symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma)
- •Patients unable to properly use a multidose dry powder inhaler or a pressurized metered-dose inhaler (pMDI).
- •Patients using any prohibited medication (including IMP within 30 days (or 6 half-lives, whichever is longer) before Visit 1) or who have not undergone the required washout period.
- •History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer).
- •Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers, sleep apnea).
- •Patients unable to give their consent, or patients of consenting age but under guardianship, or vulnerable patients
研究组 & 干预措施
Aclidinium Bromide/Formoterol Fumarate FDC 400/12μg
Experimental
8 weeks, double blind treatment period
干预措施: Aclidinium/Formoterol (Drug)
Placebo to Aclidinium/Formoterol
Placebo Comparator
8 weeks, double blind treatment period
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment
时间窗: Baseline and Week 4
Baseline values in FRC were defined as the corresponding values just before randomization on Day 1 of treatment (Week 0). Trough values were obtained prior to study drug administration.
次要结局
- Change From Baseline in Endurance Time (ET) During Constant Work Rate Cycle Ergometry at Week 8(Baseline to Week 8)
- Percentage of Inactive Patients (Mean of <6000 Steps Per Day) at Week 8(Week 8)
研究者
研究点 (1)
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