Chronic and sub acute persistent cough MedDRA version: 14.1 Level: LLT Classification code 10066656 Term: Chronic cough System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10070801 Term: Persistent cough System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Code: BC1036
Pharmaceutical Form: Capsule
CAS Number: 83-67-0
Other descriptive name: THEOBROMINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharm
Sponsors
Respicopea Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 75 years 2. Confirmed diagnosis of a persistent cough as per Section 4.2 Definition of Terms 3. Leicester Cough Questionnaire score of = 17 at baseline 4. FEV1 = 70% of predicted normal, at screening. See protocol Appendix 4 for formula for calculating predicted values. 5. Willing to use effective contraception for the duration of the study. Female subjects who are neither surgically sterilized nor post menopausal (defined as no menses for one year or an FSH value >40 mIU/L) will be required to use two methods throughout the study and for 30 days after. Besides abstinence the following contraceptive methods are acceptable: hormonal (e.g. oral, injection, transdermal patch, implant, cervical ring), barrier (e.g. condom or diaphragm with spermicidal agent) or intrauterine device. If hormonal contraceptives are used they must be used from 6 weeks before the first administration of test product. Male subjects must agree to use condoms for the duration of the study and for 30 days after. 6. Willing and able to give informed consent and of complying with the trial assessments and any other trial procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating females 2. Major surgery within the 30 days preceding the screening visit 3. Any serious infections within the 30 days prior to the screening visit 4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia uncontrolled diabetes, renal or hepatic disease or psychiatric illness/social situations that would limit compliance with study requirements 5. Known hepatitis B or C or human immunodeficiency virus (HIV) or syphilis seropositivity. Note: testing for hepatitis, syphilis or HIV will not be performed as part of the screening procedures. 6. A history of serious adverse allergic reaction to any medication 7. Treatment with another investigational medicinal product within the 30 days prior to enrolment 8. Treatment with: a. Systemic oral steroids within 7 days prior to randomisation at Visit 2 b. Theophylline and theophylline-like agents within 7 days prior to randomisation c. Opiates or opioids e.g. codeine, dextromethorphan, within 7 days prior to randomisation d. ACE inhibitors within one month prior to the screening visit 9. Depot injection of corticosteroids within 6 weeks of the screening visit 10. History suggestive of febrile illness within the last 7 days prior to the screening visit 11. Subjects with significant sputum production (defined as more than 5 ml (~one teaspoon)/day on any three days in the screening period) 12. Current smokers or past smokers who have a smoking history of >20 pack years or stopped smoking =12 months prior to screening. 13. Any pulmonary co-morbidity such as COPD, recurrent lower respiratory tract infections (=2 in the 12 months prior to screening) and bronchiectasis where cough suppression may lead to sputum retention and infection. 14. Any pulmonary abnormality on chest X-ray or CT scan performed in the twelve months prior to enrolment indicative of COPD, bronchiectasis etc. 15. Subjects diagnosed with asthma who have suffered an exacerbation requiring hospitalisation within 4 weeks prior to screening. 16. A history of cancer within the previous five years (excluding carcinoma in situ or nonmelanoma skin cancer treated by surgical excision). 17. Uncontrolled hypertension (resting systolic BP >170mmHg or resting diastolic BP >95 mm Hg) 18. A corrected QT interval of >470ms for female subjects or of >450ms for male subjects, calculated using the QTcF correction formula, or second degree or higher heart block on an ECG recording, at screening 19. Subjects known to have a sensitivity to methylxanthines and related compounds, or known to have exhibited an allergic response or sensitivity to cocoa-based products 20. History or presence of alcohol or substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the effect of BC1036 on the quality of life in subjects with persistent cough.;Secondary Objective: The secondary objectives are to investigate the effect of BC1036 on cough severity and airway sensitivity.;Primary end point(s): Cough-related quality of life assessed using the Leicester Cough Questionnaire (LCQ). The baseline-adjusted total LCQ score at Day 14 will be used as primary endpoint.;Timepoint(s) of evaluation of this end point: Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Adapted 7-day LCQ score at Day 7 • LCQ score at Day 28 • Cough visual analogue scale scores on a 100 mm scale fixed at both ends by ‘no cough’ and ‘worst cough ever’ at each visit • Airway sensitivity using capsaicin challenge in a subgroup of approximately 100 subjects at baseline and Day 14. ;Timepoint(s) of evaluation of this end point: Day 0 to day 28. | — |
Countries
United Kingdom
Outcome results
None listed