Hull Airway Reflux Questionnaire Scores Following Cough Treatment
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|ClinicalTrials.gov Identifier: NCT01515280|
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : December 12, 2013
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||57 participants|
|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 Theobromine in the Management of Cough."|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Patients taking part in supplementary study must be randomised to main study which includes a placebo arm and treatment arm
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515280
|Hull and East Yorkshire Hospitals Trust|
|Cottingham, East Riding of Yorkshire, United Kingdom, HU16 5JQ|
|Principal Investigator:||Alyn H Morice, MD, Mphil||Hull and EastYorkshire NHS Trust|