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 ]

The primary objective is to evaluate the effectiveness of HARQ in measuring a clinically significant change in HARQ score from baseline following 14 days treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome: HARQ SCORES [ Time Frame: baseline and 14 days ]

The Key secondary endpoint will be to evaluate ability of HARQ in demonstrating a clinically significant change in score from baseline in the BC036 arm compared to Placebo arm of main study.


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