A randomized double-blind placebo controlled trial evaluating the effect of esomeprazole (nexiam) 40 mg twice daily in subjects with chronic unexplained cough

ZLeuven0 个研究点开始时间: 2009年6月5日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1.18 to 75 years old.
•2.Chronic cough for at least 8 weeks.
•3.non-smoker or ex-smoker
•4.normal CXR
•5.normal spirometry
•6.no evidence of Post nasal drip syndrome (PNDS) or chronic sinusitis
•7.no improvement with inhaled corticosteroid (ICS) (
•8.Sexually active women participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
•9.Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
•Are the trial subjects under 18? yes
•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

•1.Current use of cigarettes or cigars, or smoking history of > 20 pack years
•2.Abnormality in blood chemistry or hematology profiles:
•3.Respiratory tract infection within 4 weeks of baseline.
•4.Significant concurrent medical conditions at the time of screening, including:
•Concurrent chronic obstructive pulmonary disease (COPD), or any significant respiratory diseases.
•Uncontrolled hypertension or severe cardiovascular disease
•Uncontrolled insulin-dependent diabetes mellitus.
•Known human immunodeficiency virus (HIV) infection.
•Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject.
•5.Pregnant or breast-feeding women.
•6.Concomittant treatment with warfarin, fenytoïne, diazepam, ketoconazole, itraconazole, digoxine or macrolide antibiotics (clairthromycine, roxithromycine, ..).
•7.Prohibited treatment during the study : oral corticosteroids, theophylline, H2-agonist, antacids, antitussive agents.
•8.History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
•9.History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

发起方

ZLeuven