Hull Airway Reflux Questionnaire Scores Following Cough Treatment

NHS Trust

Status: Completed

Conditions: Cough

Study type: Observational

Funder types: Other

Identifiers

NCT01515280

11112011

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Willing and able to comply with study procedures
3. Able to provide written informed consent to participate

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.

Trial design

57 participants in 1 patient group

Chronic cough

Description:

Patients taking part in supplementary study must be randomised to main study which includes a placebo arm and treatment arm