Clinical Trial: Hull Airway Reflux Questionnaire Scores Following Cough Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Supplementary Study of Hull Airway Reflux Questionnaire Scores Before and After Treatment Study: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theob
Brief Summary: The aim of this study is to have those patients taking part in the Clinical trial-: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough. Complete the Hull Airway Reflux Questionnaire (HARQ) at randomisation and repeat the questionnaire at the end of the 14 day treatment period. The investigators hope to demonstrate a clinically significant change in HARQ scores of at least 16 points from before and after treatment. Furthermore the investigators would hope to show a significantly improved HARQ score in patients on the BC036 arm of the study compared to the placebo arm.
Detailed Summary:
Sponsor: Hull and East Yorkshire Hospitals NHS Trust
Current Primary Outcome: Hull Airway Reflux Questionnaire score [ Time Frame: baseline and 2 weeks later ]
Original Primary Outcome: Same as current
Current Secondary Outcome: HARQ SCORES [ Time Frame: baseline and 14 days ]
Original Secondary Outcome: Same as current
Information By: Hull and East Yorkshire Hospitals NHS Trust
Dates:
Date Received: January 18, 2012
Date Started: January 2012
Date Completion:
Last Updated: December 11, 2013
Last Verified: December 2013