EUCTR2012-005794-31-GB进行中（未招募）不适用
A randomised, double-blind, placebo-controlled crossover study to assess the efficacy of a single dose of 100mg of VRP700 by inhalation in reducing the frequency and severity of cough in adult patients with Idiopathic Pulmonary Fibrosis - EPOCh
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Male or female patients, women (or female partners of male patients) to be of non childbearing potential, or of child bearing potential who either abstain from sexual intercourse, have a sterile partner or practice two medically approved methods of contraception
- •Aged =18 years
- •Self-reported history of troublesome daily cough for more than 8 weeks
- •Self-reported stable clinical condition and cough frequency for more than 4 weeks prior to screening
- •Diagnosis of idiopathic pulmonary fibrosis following review by a Multi-Disciplinary Team (MDT). The diagnosis of IPF requires the following:
- •a.Exclusion of other known causes of ILD (e.g. domestic or occupational environmental exposures, connective tissue disease, or drug toxicity) and
- •b.Either the presence of the usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT) in patients not subjected to surgical lung biopsy
- •c.Or specific combinations of HRCT and surgical lung biopsy pattern in patients subjected to surgical lung biopsy
- •Have given written informed consent
- •Ability to comply with the requirements of the study
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Current smokers, including ‘social smokers’ and those who have given up less than 6 months ago
- •Concurrent use of medications likely to suppress / affect cough including; immunosuppressives (eg
- •azathioprine), codeine and related products, morphine, pregabalin, gabapentin, amitriptylline angiotensin
- •converting enzyme inhibitors (type 1), baclofen or high dose systemic steroids i.e. prednisolone >20mg daily
- •or equivalent. Those patients on lower doses of steroids for >1 month and still complaining of cough, and
- •those patients taking Nacetyl
- •cysteine, and those taking amitriptyline for reasons other than cough may be
- •Concurrent use of pirfenidone, unless receiving a stable dose for at least 4 weeks prior to Screening
- •Resting blood oxygen saturation of <90 %
- •Patients with clinically apparent heart failure or a clinically significant abnormal ECG at Screening
- •Self-reported history of chest or upper airway infection within the past 4 weeks
- •Any condition that may affect cough response, such as stroke, Parkinson’s disease or diabetics with autonomic neuropathy. Clinically stable diabetics (i.e. on stable medication for >1 month and not experiencing symptoms of hypoglycaemia) without known autonomic neuropathy may be enrolled
- •A history of asthma or obstructive airway disease, or those with an FEV1/FVC ratio at screening of <70%
- •A history of epilepsy or myasthenia gravis
- •Evidence of significant of hepatic or renal dysfunction
- •Any clinically significant abnormal laboratory safety test (biochemistry, haematology and dipstick urinalysis) at screening
- •Pregnancy or breast feeding
- •Participation in another trial or use of an investigational drug within the preceding 4 weeks
- •A history of active alcohol abuse or drug addiction
研究者
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