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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Respicopea Limited
• Treatments: Theobromine

Criteria

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.