Study of the Safety and Effectiveness of BC1036 Capsules to Treat Frequent Long-Term Cough

This is an interventional treatment trial for Cough focused on measuring Chronic, Acute, Persistent, Longterm, Cough Read More

Inclusion Criteria:

• Male or female aged 18 to 75 years.
• Confirmed diagnosis of a persistent cough.
• Leicester Cough Questionnaire score of ≤ 17 at baseline.
• FEV ≥ 70% of predicted normal, at screening. See protocol Appendix 4 for formula for calculating predicted values.
• 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.
• Willing and able to give informed consent and of complying with the trial assessments and any other trial procedures.

Exclusion Criteria:

• Pregnant or lactating females.
• Major surgery within the 30 days preceding the screening visit.
• Any serious infections within the 30 days prior to the screening visit.
• 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.
• Known hepatitis B or C or human immunodeficiency virus (HIV) or syphilis seropositivity.
• A history of serious adverse allergic reaction to any medication.
• Treatment with another investigational medicinal product within the 30 days prior to enrollment.

• Treatment with:

  • Systemic oral steroids within 7 days prior to randomisation at Visit 2.
  • Theophylline and theophylline-like agents within 7 days prior to randomisation.
  • Opiates or opioids e.g. codeine, dextromethorphan, within 7 days prior to randomisation.
  • ACE inhibitors within one month prior to the screening visit.
• Depot injection of corticosteroids within 6 weeks of the screening visit.
• History suggestive of febrile illness within the last 7 days prior to the screening visit.
• Subjects with significant sputum production (defined as more than 5 ml (~one teaspoon)/day on any three days in the screening period).
• Current smokers or past smokers who have a smoking history of > 20 pack years or stopped smoking ≤ 12 months prior to screening.
• 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.
• Any pulmonary abnormality on chest X-ray or CT scan performed in the twelve months prior to enrolment indicative of COPD, bronchiectasis etc.
• Subjects diagnosed with asthma who have suffered an exacerbation requiring hospitalisation within 4 weeks prior to screening.
• A history of cancer within the previous five years (excluding carcinoma in situ or nonmelanoma skin cancer treated by surgical excision).
• Uncontrolled hypertension (resting systolic BP > 170mmHg or resting diastolic BP > 95 mm Hg).
• 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.
• 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.
• History or presence of alcohol or substance abuse.