Oral BC1036 in the Management of Cough

• Research type

  Research Study

• Full title

  A Multicentre, Double-Blind, Placebo-Controlled, Adaptive Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough. Sponsor code: BC1036-001, (HCR: 1780/BCO).

• IRAS ID

  87172

• Contact name

  Alyn Morice

• Sponsor organisation

  Respicopea Limited

• Eudract number

  2011-004589-14

• ISRCTN Number

  N/A

• Research summary

  Cough is a common and disabling symptom. At any one time 20% of the population have a troublesome cough and sufferers consume 75 million doses of over-the-counter anti-tussive (anti-cough) medication annually. Chronic cough can be the presenting symptom of almost all respiratory conditions; it can also occur in the absence of overt lung pathology. The only study to grade cough severity found 7% of a general population had cough sufficient to interfere with activities of daily living on at least a weekly basis in the UK. Cross sectional studies have consistently shown that chronic cough is particularly prevalent in middle aged females. This is a placebo-controlled, double-blind, parallel group study in subjects with persistent cough (chronic or sub-acute), treatment resistant after a routine clinical assessment as outlined in the BTS Recommendations for the Management of Cough in Adults and despite adequate treatment of any associated potential aggravating factors or without the continuance of any obvious precipitating factors. The objective is to investigate the effect of BC1036 on cough-related quality of life and cough severity following 2 weeks' treatment. It is planned to recruit 288 evaluable subjects from cough clinics, secondary and primary care centres in the UK. Subjects will receive either BC1036 or placebo over a period of 14 days. Eligible subjects will be required to attend the clinic on five occasions: screening, baseline, days 7, 14, and a follow up visit at day 28. At every visit the subjects will complete the Leicester Cough Questionnaire (LCQ), and a cough Visual Analogue Score (VAS). Spirometry will be performed for measurement of lung function. Blood samples will be drawn for safety clinical laboratory parameters and physical examinations and ECG will be performed. Subjects should be seen for all visits on the designated day ñ 1 day, except Day 28 ñ 2 days.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  11/NE/0375

• Date of REC Opinion

  16 Mar 2012

• REC opinion

  Further Information Favourable Opinion