NCT01599884Unknown不适用
Effects of High-Dose N-Acetylcysteine on Respiratory Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis: A Randomized, Placebo-Controlled Trial-1
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Changes in the St. George's Respiratory Questionnaire
研究概览
简要总结
N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is widely prescribed for patients with chronic obstructive pulmonary disease (COPD), particularly for those who have accompanying symptoms of chronic cough and sputum production. Randomized, placebo controlled indicate that it is safe and that it may have some clinical benefit when used at relatively low doses. It is postulated that substantially higher doses of NAC will be well-tolerated and will provide better symptom control while also decreasing blood makers of oxidant stress and inflammation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Capability to provide written informed consent
- •Age ≥ 40 years and ≤ 85 years
- •FEV1/FVC ratio (post bronchodilator) < 70%
- •FEV1 (post bronchodilator) < 65%
- •Presence of chronic cough and sputum production defined as the following:
- •Presence of chronic cough and sputum will be defined by responses to the first two questions on the SGRQ (see Appendix A). Subjects who respond positively to both question 1 (cough) and question 2 (sputum) on the SGRQ as either "several days per week" or "almost every day" will be eligible
- •Current or former smoker with lifetime cigarette consumption of at least 10 pack-years
- •Negative serum pregnancy test at the baseline visit if patient is a pre-menopausal female (menopause defined as absence of a menstrual cycle in the last 12 months)
- •Must be fluent in speaking the English language
- •Exclusion Criteria
- •Not fully recovered for at least 30 days from a COPD exacerbation characterized by typical symptoms and treated with antibiotics or prednisone
- •Known allergy or sensitivity to NAC or albuterol
- •Any patient with unstable cardiac disease
- •Any patient with a documented history of uncompensated congestive heart failure in the last 2 years
- •Clinical diagnosis of asthma, bronchiectasis, cystic fibrosis, or severe alpha-1 antitrypsin deficiency
- •Active lung cancer or history of lung cancer if it has been less than 2 years since lung resection or other treatment. If history of lung cancer, must have no evidence of recurrence in the 2 years preceding the baseline visit.
- •Undergoing active treatment for malignancy except for hormonal therapy (i.e. prostate cancer, breast cancer) or non-metastatic skin cancer and are not symptomatic
- •Chronic kidney disease with an estimated GFR of < 30 ml/min. GFR will be estimated using the Modification of Diet in Renal Disease (MDRD) formula
- •History of cirrhosis with evidence of portal hypertension (ascites, chronic edema)
- •Participation in a pulmonary rehabilitation program or completion within past 6 weeks
- •Prisoners or institutionalized patients
- •Participation in another study involving an investigational product within 30 days of the baseline visit
- •Pregnant or breast-feeding patients.
- •Use of guaifenesin in the last 30 days
- •Currently on long acting nitrates for angina or heart failure
- •Abnormalities in screening blood work defined as:
- •WBC < 3.0 or > 15.0 K/cmm
- •Hemoglobin < 9.0 or > 17.0 gm/dl
- •Platelets < 75 or > 400 K/cmm
- •ALT > 3 times the upper limit of normal
- •INR > 1.5 unless on warfarin therapy o Any concomitant condition that might endanger the patient through participation in the study or interfere with study procedures, as assessed by the investigator
排除标准
- 未提供
研究组 & 干预措施
N-acetylcysteine
Active Comparator
N-acetylcysteine, 1800 mg twice daily
干预措施: N-acetylcysteine (Drug)
Sugar pill
Placebo Comparator
Identical to active drug
干预措施: Oral acetylcysteine (Drug)
结局指标
主要结局
Changes in the St. George's Respiratory Questionnaire
时间窗: 1 year
次要结局
未报告次要终点
研究者
Dennis Niewoehner
Staff physician
Center for Veterans Research and Education
研究点 (1)
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