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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic cough | Patients taking part in supplementary study must be randomised to main study which includes a placebo arm and treatment arm |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HARQ SCORES | 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. | baseline and 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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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patients attending chronic cough clinics
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| Name | Affiliation | Role |
|---|---|---|
| Alyn H Morice, MD, Mphil | Hull and EastYorkshire NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull and East Yorkshire Hospitals Trust | Cottingham | East Riding Of Yorkshire | HU16 5JQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28839984 | Result | 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. |
| Label | URL |
|---|---|
| Publication Link | View source |
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| ID | Term |
|---|---|
| D003371 | Cough |
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| D013568 | Pathological Conditions, Signs and Symptoms |