EUCTR2013-003301-26-GB进行中（未招募）1 期
A randomised placebo-controlled pilot trial of omeprazole in idiopathic pulmonary fibrosis (IPF) - Pilot trial of omeprazole in idiopathic pulmonary fibrosis (Acronym :
ewcastle Upon Tyne Hospitals NHS Foundation Trust0 个研究点开始时间: 2013年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •A pragmatic clinical definition of IPF will be used, in which recruited patients must fulfill all of the following criteria
- •IPF is considered the most likely diagnosis by the regional interstitial lung disease multidisciplinary team meeting (ILD-MDT)
- •history of cough, with or without exertional dyspnoea
- •high resolution computed tomography (HRCT) scan features of honeycombing in a predominantly basal and subpleural distribution
- •bibasal crackles on auscultation
- •features of a restrictive ventilatory defect (vital capacity (VC) <90% predicted and/or diffusion factor for carbon monoxide (Tco) <90% predicted)
- •aged 40-85 years
- •Patients with radiological emphysema will be eligible so long as the diagnosis of IPF is secure, ie all the features above are satisfied.
- •If the regional ILD-MDT cannot reach a clear consensus as to the diagnosis, the case will be referred to 2 experts in ILD from outside the region, and the patient will be eligible if both consider IPF to be the most likely diagnosis.
- •Patients taking a PPI during screening will potentially be eligible. In these cases the indication for on-going treatment will be reviewed.
- •Patients taking short courses (eg 2 months) of PPI will be eligible once the treatment has been discontinued for a minimum of 1 month.
- •There are few licensed indications for long-term omeprazole other than Zollinger-Ellison syndrome. Therefore, unless there is a known diagnosis of Zollinger-Ellison or a history of significant dyspepsia or gastrointestinal bleeding during a previous discontinuation of PPI, patients on long-term PPI will be asked to consider a trial of supervised discontinuation.
- •If patients taking omeprazole (or a related stomach treatment) wish to take part, we shall contact the GP to check that the GP is aware and in agreement. The patient will then be asked to sign a consent form to agree to try a period off treatment for 2 weeks. If symptoms return during that 2- week period the patient should go back on treatment and not take part in the study. If patients manage well without the treatment for 2 weeks, they will be asked to sign a second consent form before starting the study.
- •Patients taking antacids, prokinetics or raft alginates at the time of screening will be eligible if they have been off these treatments for a period of at least 2 weeks.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •known allergy to omeprazole or other PPI
- •concomitant use of warfarin, diazepam, phenytoin or ketoconazole
- •concomitant use of a regular PPI, antacid, prokinetic or raft alginate during the trial period.
- •history of upper respiratory tract infection, lower respiratory tract infection or exacerbation of IPF in the 4 weeks before starting study drugs
- •active trial of treatment for IPF (eg prednisolone, pirfenidone, nintedanib, N-acetylcysteine) started in the 4 weeks before starting study drugs
- •documented history of hepatic cirrhosis
- •pregnancy or lactation
- •ILD-MDT considers the most likely cause of the patient’s ILD to be a condition other than IPF, for example rheumatoid lung, systemic sclerosis ILD, asbestosis, chronic hypersensitivity pneumonitis, sarcoidosis, etc.
- •concurrent enrolment in a trial of a CTIMP for IPF
研究者
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