NCT00639496已完成3 期
Idiopathic Pulmonary Fibrosis International Group Exploring NAC I Annual Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Zambon SpA
- 入组人数
- 184
- 试验地点
- 7
- 主要终点
- Vital capacity (VC) and diffusion capacity for CO (DLCO)
研究概览
简要总结
The purpose of this study is to determine whether NAC added to prednisone, and azathioprine has a better effect on lung function, radiology and clinical condition than placebo + prednisone in combination with azathioprine after 6 and 12 months.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IPF according to the International Consensus Statement
- •Bronchoalveolar lavage (BAL) showing no features to support an alternative diagnosis.
- •Patients in whom it was possible to determine single breath DLco.
- •Patients with newly or previously diagnosed IPF, in whom it was clinically justified to use the standardised regimen azathioprine plus prednisone
排除标准
- •Known intolerance to N-Acetylcysteine.
- •Patients with respiratory infections at study entry should be excluded until the infections have been treated successfully (VC and Dlco comparable with the values before the infection).
- •Patients with pre-existing disease that interferes with the evaluation of IPF: extensive old TBC lesions, significant bronchiectasis, moderate or severe COPD.
- •Patients with malignancy in the last 5 years. If the patient had a malignancy in the past and is free of malignancy for more than five years, the patient is regarded as healed.
- •Patients with heart failure.
- •Patients with hepatic function abnormalities contraindicating the use of azathioprine (i.e. clinically significant abnormalities of PTT and/or GGT).
- •Patients with a renal clearance < 10ml/min and/or hematuria and/or proteinuria of collagen vascular disease origin. A renal clearance is only performed in the presence of an abnormal serum creatinine and/or serum urea level.
- •Patients who are artificially ventilated.
- •Prednisone at a dose > 0.5 mg/kg/day (or other glucocorticoids such as triamcinolone, dexamethasone or methylprednisolone at an equivalent dose) or azathioprine at a dose > 2 mg/kg/day during the last month prior to inclusion.
- •Use of other immunosuppressives (such as cyclophosphamide and colchicine) is not allowed in the last month and for the duration of the trial.
- •Any form of anticancer therapy or methotrexate are not allowed when used for more than 1 week in the past and for the duration of the trial.
- •Amiodarone or nitrofurantoin are not allowed in the last 5 years, when used for more than 1 week in the past and for the duration of the trial.
- •Allopurinol, oxypurinol, thiopurinol, anti-oxidants (e.g. vitamin E) or glutathione supplements are not allowed in the last month and during the trial.
- •The use of interferon or other antifibrotics (e.g. pirfenidone) is not allowed in the past and during the study.
- •The use of NAC therapy at a dosage of more than 600 mg/day is not allowed in the last 3 years for a total period of more than 3 months.
- •Patients suffering or having suffered from documented active ulcer within the last 3 years.
- •Patients in whom the standardised treatment regimen is contraindicated or not justified.
- •Pregnancy.
- •Known or suspected drug or alcohol abuse.
- •Patients on other investigational compounds or participating in clinical trials on investigational compounds within the last 3 months.
- •Patients expected to be non-compliant in taking the medication.
研究组 & 干预措施
1
Experimental
patients taking NAC 600 mg t.i.d.
干预措施: n-acetylcysteine (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Vital capacity (VC) and diffusion capacity for CO (DLCO)
时间窗: at 6 and 12 months
次要结局
- clinical, radiologic and physiologic (CRP)-score(at 6 and 12 months)
研究者
研究点 (7)
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