Clinical trial: Study of the Safety and Effectiveness of BC1036 Capsules to Treat Frequent Long-Term Cough (NCT01656668)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction