Clinical trial NCT01656668 (phase 3, status: completed)
Conditions: cough
ICD codes: R05.1, R05.2, R05.3, R05.4, R05.9, G44.83, J45.991
Drugs: bc1036
SMILES: CN1C=NC2=C1C(=O)NC(=O)N2C
Eligibility 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.