Study of the Safety and Effectiveness of BC1036 Capsules to Treat Frequent Long-Term Cough
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the effect of BC1036 (theobromine) on
      cough-related quality of life and cough severity following 2 weeks' treatment.
    

Detailed description: 
      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.

      The investigational medicinal product BC1036 (theobromine) is being developed as a
      non-codeine, non-narcotic treatment for persistent cough. Theobromine is a well characterised
      molecule with a long history of safe use both as a medicine and as a food product. As a
      member of the xanthine family, it bears structural and pharmacological similarity to caffeine
      and theophylline, both of which have long been approved for medicinal use.

      This is a placebo-controlled, double-blind, parallel group study of BC1036 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 ± 1 day, except Day
      28 ± 2 days.
    

Intervention name(s): BC1036
Intervention type(s): Drug
Other intervention name(s): Theobromine; CAS number 83-67-0; EV Substance code SUB15511MIG
Intervention MeSH terms: Theobromine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic; Acute; Persistent; Longterm; Cough