gastroesophageal reflux and chronic cough MedDRA version: 9.1 Level: LLT Classification code 10018203 Term: GERD MedDRA version: 9.1 Level: LLT Classification code 10066656 Term: Chronic cough
Conditions
Interventions
Trade Name: Nexiam
Pharmaceutical Form: Prolonged-release tablet
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
UZLeuven
UZLeuven
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Belgium
Outcome results
None listed