We will be using Nexium to treat gastro-oesophageal reflux and in return this will reduce reflux related cough ( a manifestation of reflux) MedDRA version: 3 Level: 2 Classification code 10013946
Conditions
Interventions
Trade Name: Nexium
Pharmaceutical Form:
INN or Proposed INN: esomeprazole
CAS Number: 161973-10-0
Current Sponsor code: NA
Sponsors
Hull and east Yorkshire Hospitals Trust, Research and Deveopment, admin porta cabin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of either sex who meet the following criteria will be considered for inclusion in the study. ? Written informed consent ? Patients with a history of chronic cough (at least 3 months duration), and associated symptoms of gastro-esophageal reflux. ? Male and female subjects of at least 18 yrs of age ? Subjects able to understand the study and co-operate with the study procedures ? Subjects who consent to their general practitioner (GP) being informed of their study participation Are the trial subjects under 18? no 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: ? Female subjects who are pregnant, or lactating, or who are of child bearing potential but are not using contraceptive measures ? Suffering from any concomitant disease which may interfere with study procedures or evaluation. ? A lower respiratory tract infection 4 weeks prior to entry on to study ? Participation in another study (use of investigational product) within 30 days preceding entry on to study. ? Alcohol or drug abuse ? Inability to follow study procedures ? Use of PPI or H2 receptor antagonists (H2Ras) 4weeks prior to enrolment ? Use of Liquid alginates 2 weeks prior to enrolment ? Use of opiates to treat cough 1 week prior to enrolment. ? Subjects who are taking Angiotensin Converting Enzymes (ACE) inhibitors. ? Subjects who have significant pathology on most recent chest X-Ray.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of this study is to demonstrate that esomeprazole (20 mg, twice daily, given for 8 weeks) is superior to placebo in the treatment of chronic cough due to reflux, with respect to the daily diary cough index ; Secondary Objective: The secondary objectives are to demonstrate that esomeprazole (20 mg, twice daily, given for 8 weeks) is superior to placebo in the improvement of symptoms (cough specific LPR score), The Leicester cough score and the subjects overall assessment of treatment. Changes in spirometry, cough challenge, methacholine challenge and laryngoscopy reflux score will also be compared between treatments. ;Primary end point(s): The primary efficacy variable will be the change in cough index ( derived from daily diary assessments of the severity of cough score by taking the average score over the final 14 days of treatment) in patients on 8 weeks treatment with esomeprazole 20 mg BD compared with patients on 8weeks treatment with placebo. | — |
Countries
United Kingdom
Outcome results
None listed