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

• Conditions: gastroesophageal reflux and chronic cough; MedDRA version: 9.1Level: LLTClassification code 10018203Term: GERD; MedDRA version: 9.1Level: LLTClassification code 10066656Term: Chronic cough

• Registration Number: EUCTR2009-012505-18-BE
• Lead Sponsor: ZLeuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of esomeprazole (nexiam) 40 mg b.i.d vs. placebo in subjects with chronic cough not due to ENT disease and asthma;Secondary Objective: to assess the presence of reflux, reflux-cough association and predictive value of reflux assessment on the primary outcome.;Primary end point(s): The Primary objective of this study is to assess the efficacy of esomeprazole (nexiam®) 40 mg twice daily vs. placebo in subjects with chronic cough not due to ENT disease and asthma.