NCT02182856已完成4 期
A Randomised, Double-blind, Active-controlled, Within-patient Trial Comparing the Effect of Single Doses of Nebulised Ipratropium 500µg, Salbutamol Sulphate 3mg, Salbutamol 6mg and the Combination Therapy Salbutamol Sulphate 3 mg Plus Ipratropium 500µg on Arterial Oxygen Saturation in Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Area under the curve of arterial oxygen saturation (SaO2)
研究概览
简要总结
Study to compare the effects of nebulised salbutamol or ipratropium alone in patients with COPD with those of combined salbutamol and ipratropium nebuliser solution on arterial oxygen saturation (SaO2) and to characterise patients with COPD (chronic obstructive pulmonary disease) at risk of significant arterial oxygen desaturation following nebulised salbutamol.
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
- Double (Participant, Investigator)
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
- •Male and female patients with moderate to severe stable COPD:
- •Patients with a diagnosis of chronic bronchitis and/or emphysema
- •FEV1 <65% of predicted value without regard to prior treatment
- •Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment
- •Patients must not have had a respiratory infection or an exacerbation of COPD during the four weeks immediately prior to entering the trial
- •Patients must not have changed their normal treatment for COPD during the four weeks immediately prior to entering the trial
- •Patient aged ≥40 years
- •Patients with a smoking history of ≥15 pack-years
- •Patients must have given informed consent to participate in the trial
排除标准
- •Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans
- •Patients with any of the following:
- •untreated angle closure glaucoma
- •hypertrophic obstructive cardiomyopathy
- •tachyarrhythmia
- •recent myocardial infarction (within six months of screening visit)
- •severe organic cardiac or vascular disorder
- •untreated hyperthyroidism
- •diabetes mellitus (after approval of Protocol Amendment 1, the inclusion of well controlled diabetic patients was allowed)
- •Patients who are pregnant, or who are planning a pregnancy, and nursing mothers
- •Patients known to be hypersensitive to anticholinergic drugs or to β2 agonists
- •Patients known to abuse drugs or alcohol
- •Patients, who in the opinion of the investigator, are likely not to co-operate with any of the requirements of the trial
- •Patients with a PaO2 (arterial carbon dioxide tension) <56 mmHg (7.5 kPa) at rest while breathing air without regard to prior treatment
- •Patients with a SaO2 ≤85% at rest while breathing air without regard to prior treatment
- •Patients who are taking part in another investigation, and patients who have participated in another clinical trial during the three months immediately preceding entry to this trial
- •Patients on home oxygen concentrator therapy
- •Patients who have previously participated in the randomised phase of this trial
研究组 & 干预措施
Ipratropium bromide/salbutamol sulphate
Experimental
Randomised sequence of four different treatments
- Ipratropium bromide 500 µg/salbutamol sulphate 3 mg
- Ipratropium 500 µg
- Salbutamol sulphate 3 mg
- Salbutamol sulphate 6 mg
干预措施: Ipratropium bromide 500 µg/salbutamol sulphate 3 mg (Drug)
Ipratropium bromide/salbutamol sulphate
Experimental
Randomised sequence of four different treatments
- Ipratropium bromide 500 µg/salbutamol sulphate 3 mg
- Ipratropium 500 µg
- Salbutamol sulphate 3 mg
- Salbutamol sulphate 6 mg
干预措施: Ipratropium 500 µg (Drug)
Ipratropium bromide/salbutamol sulphate
Experimental
Randomised sequence of four different treatments
- Ipratropium bromide 500 µg/salbutamol sulphate 3 mg
- Ipratropium 500 µg
- Salbutamol sulphate 3 mg
- Salbutamol sulphate 6 mg
干预措施: Salbutamol sulphate 3 mg (Drug)
Ipratropium bromide/salbutamol sulphate
Experimental
Randomised sequence of four different treatments
- Ipratropium bromide 500 µg/salbutamol sulphate 3 mg
- Ipratropium 500 µg
- Salbutamol sulphate 3 mg
- Salbutamol sulphate 6 mg
干预措施: Salbutamol sulphate 6 mg (Drug)
结局指标
主要结局
Area under the curve of arterial oxygen saturation (SaO2)
时间窗: over 70 min observation period from each start of nebulisation
次要结局
- Forced expiratory volume in the first second of expiration (FEV1)(up to 60 min after end of nebulisation)
- Forced (expiratory) vital capacity (FVC)(up to 60 min after end of nebulisation)
- Relaxed (expiratory) vital capacity (VC)(up to 60 min after end of nebulisation)
- Forced expiratory ratio (FER)(up to 60 min after end of nebulisation)
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