ACTRN12618001838202已完成1 期
A Randomized Open-Label, Phase 1b Study of the Safety of Pirfenidone Solution for Inhalation (AP01) in Patients with Idiopathic Pulmonary Fibrosis (ATLAS Study)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 91
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 90 No limit（—）
- 性别
- All
入选标准
- •1.Male and female patients, at least 40 years of age at Screening
- •2.Not eligible for oral pirfenidone and nintedanib due to national formulary restrictions OR intolerant to or unwilling to start oral pirfenidone and nintedanib, if previously offered
- •Diagnosis of IPF
- •3.Clinical symptoms consistent with IPF of greater than or equal to 12 months duration (with or without IPF diagnosis)
- •4.Diagnosis of IPF, defined as the first instance in which a patient was informed of having IPF, no more than 60 months before randomization
- •5.Extent of fibrotic changes (honeycombing, reticular changes) greater than the extent of emphysema on HRCT scan
- •6.No features supporting an alternative diagnosis on transbronchial biopsy, BAL, or surgical lung biopsy, if performed
- •7.FVC % predicted greater than or equal to 40% and less than or equal to 90% at Screening based on Global Lung Initiative equations. The first 20 patients randomized must have FVC greater than or equal to 50% predicted. After the first 20 patients have randomized, patients with FVC greater than 40% and less than 50% predicted at Screening will be allowed to be randomized in the study but randomization for these patients will be capped at 20 patients
- •8.Change in FVC (measured in liters) between Screening and Day 1 (pre-dose measurement) must be less than 10% relative difference
- •9.DLCO greater than or equal to 30% and less than or equal to 90% at Screening
- •10.In the investigator’s opinion, no evidence of improvement in measure of IPF disease severity over the preceding year
- •11.FEV1/FVC greater than or equal to 70%
- •12.Able to understand and sign a written informed consent form
- •13.Able to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements, including the concomitant medication restrictions, throughout the study
排除标准
- •1.Significant clinical worsening of IPF between Screening and Day 1, in the opinion of the investigator
- •2.Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the investigator
- •3.History of acute IPF exacerbation requiring hospitalization in the last 3 months
- •4.History of clinically significant environmental exposure known to cause pulmonary fibrosis, including but not limited to drugs (such as amiodarone), asbestos, beryllium, radiation, and domestic birds
- •5.Known explanation for interstitial lung disease, including but not limited to radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus, viral hepatitis, and cancer
- •6.Clinical diagnosis of any connective tissue disease, including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
- •7.Current diagnosis of asthma or chronic obstructive pulmonary disease
- •8.Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis
- •9.Females with a positive pregnancy test at Screening or are currently breastfeeding
- •10.Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 6 months. This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma)
- •11.Any condition other than IPF that, in the opinion of the investigator, is likely to result in the death of the patient within the next 6 months
- •12.History of severe hepatic impairment or end-stage liver disease or ALT or AST greater than 5 times the upper limit of normal at Screening
- •13.History of end-stage renal disease requiring dialysis
研究者
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