Hull Airway Reflux Questionnaire Scores Following Cough Treatment
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."
1 other identifier
observational
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 18, 2012
CompletedFirst Posted
Study publicly available on registry
January 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 15, 2019
July 1, 2019
1.5 years
January 18, 2012
July 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hull Airway Reflux Questionnaire score
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.
baseline and 2 weeks later
Secondary Outcomes (1)
HARQ SCORES
baseline and 14 days
Study Arms (1)
Chronic cough
Patients taking part in supplementary study must be randomised to main study which includes a placebo arm and treatment arm
Eligibility Criteria
patients attending chronic cough clinics
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hull and East Yorkshire Hospitals Trust
Cottingham, East Riding Of Yorkshire, HU16 5JQ, United Kingdom
Related Publications (1)
Morice AH, McGarvey L, Pavord ID, Higgins B, Chung KF, Birring SS. Theobromine for the treatment of persistent cough: a randomised, multicentre, double-blind, placebo-controlled clinical trial. J Thorac Dis. 2017 Jul;9(7):1864-1872. doi: 10.21037/jtd.2017.06.18.
PMID: 28839984RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alyn H Morice, MD, Mphil
Hull and EastYorkshire NHS Trust
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2012
First Posted
January 24, 2012
Study Start
January 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 15, 2019
Record last verified: 2019-07