Hull Airway Reflux Questionnaire Scores Following Cough Treatment
This study has been completed.
Information provided by (Responsible Party):
Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust
First received: January 18, 2012
Last updated: December 11, 2013
Last verified: December 2013
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.
||Observational Model: Case-Only
Time Perspective: Cross-Sectional
||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 Theobromine in the Management of Cough."
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
Patients taking part in supplementary study must be randomised to main study which includes a placebo arm and treatment arm
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
patients attending chronic cough clinics
- Male/females meeting eligibility criteria for study: - A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough.
- Willing and able to comply with study procedures
- Able to provide written informed consent to participate
1. Any subject meeting any exclusion criteria on the study "A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough." Will be excluded from this study.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01515280
|Hull and East Yorkshire Hospitals Trust
|Cottingham, East Riding of Yorkshire, United Kingdom, HU16 5JQ |
Hull and East Yorkshire Hospitals NHS Trust
||Alyn H Morice, MD, Mphil
||Hull and EastYorkshire NHS Trust
No publications provided
||Prof A H Morice, Professor of Respiratory Medicine, Hull and East Yorkshire Hospitals NHS Trust
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 18, 2012
||December 11, 2013
||United Kingdom: Research Ethics Committee
Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
ClinicalTrials.gov processed this record on March 26, 2015