EUCTR2007-002324-15-GB进行中（未招募）不适用
The efficacy and safety of co-trimoxazole therapy in patients with idiopathic interstitial pneumonia - TIPAC
niversity of East Anglia0 个研究点开始时间: 2008年3月17日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female, aged greater than 40 years
- •2.Female subjects must be of non-childbearing potential, defined as follows
- •postmenopausal females who have had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH>40mIU/ml
- •females who have had a hysterectomy or bilateral oophorectomy for at least 6 weeks
- •3.Able to provide informed consent
- •4.A clinical labelled diagnosis of fibrotic idiopathic interstitial pneumonia with HRCT scan features compatible with Usual Interstitial Pneumonia (UIP) or Fibrotic Non-specific Interstitial Pneumonia (NSIP). The following criteria adapted from the ATS/ERS consensus statement will be used for the diagnosis the clinical manifestation of UIP (idiopathic pulmonary fibrosis):
- •Major Criteria (All present)
- •oExclusion of other known causes of interstitial lung disease, such as drug toxicities, environmental exposures, and collagen vascular diseases
- •oAbnormal pulmonary function studies that include evidence of restriction with or without impaired gas exchange
- •oBibasal reticular abnormalities with minimal ground glass opacities on HRCT
- •Minor criteria (two out of three features)
- •oInsidious onset of otherwise unexplained dyspnoea on exertion
- •oDuration of illness 3 months
- •oBibasal inspiratory crackles (dry or ‘‘Velcro-’’ type in quality)
- •Patients with clinical diagnosis of non-specific interstitial pneumonia will be entered if fibrotic features are predominant on HRCT. Histology will not be required as an entry criterion.
- •5.Patients will have had initial treatment of prednisolone +/- azathioprine, as indicated and described in the current BTS guidelines, without a without a significant response to immunosuppressive therapy that would make the physician doubt the diagnosis of fibrotic idiopathic interstitial pneumonia.
- •6.Patients should be on stable treatment regimen for at least 6 weeks. This will include oral prednisolone up to a dose of 20mg per day +/- azathioprine. Patients receiving higher doses of up to 0.5mg/kg may be enrolled in exceptional circumstances after discussion with the principal investigator.
- •7.MRC dyspnoea score of ?2
- •8.A normal serum folate and B12 (to ensure no bone marrow or neurological adverse effects occur with folate therapy to B12 deficient individuals) is required at screening.
- •9.Subjects have a 12 lead ECG recording that does not demonstrate any clinically important abnormality that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.A secondary cause for pulmonary fibrosis including a diagnosis of asbestosis, drug induced pulmonary fibrosis, collagen vascular disease or other secondary pulmonary fibrosis.
- •2.A recognised significant co-existing respiratory disorder.
- •3.Long-term oxygen therapy.
- •4.Receiving anti-oxidant therapy including acetylcysteine within the last 6 weeks.
- •5.A respiratory tract infection within the last 2 months
- •6.Overt and persistent heart failure, a myocardial infarction within 3 years, ischaemic heart disease requiring more than one regular therapy or a clinically significant uncontrolled arrhythmia (including Mobitz type II or third degree heart block).
- •7.Significant medical, surgical or psychiatric disease that in the opinion of the patients’ attending physician would affect subject safety or influence the study outcome.
- •8.Women who are pregnant or are breast-feeding.
- •9.Patients receiving immunosuppressant medication (with the exception of prednisolone and azathioprine according to guidelines).
- •10.Co-trimoxazole allergy or intolerance and patients receiving medication known to interact with co-trimoxazole.
- •11.Untreated folate or B12 deficiency.
- •12.Known glucose-6-phosphate dehydrogenase deficiency.
- •13.Receipt of an investigational drug or biological agent within the 4 weeks prior to entry in to this study.
- •14.Patients with evidence of drug or alcohol misuse
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