Clinical trial: Strategy to Improve Adherence of Roflumilast (NCT02018432)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female older than 40 years

          2. Clinical diagnosis of COPD (confirmed with a post-bronchodilator forced expiratory
             volume in 1 s [FEV1]/forced vital capacity [FVC] ratio ≤70%) at least 4 weeks prior to
             the study and post-bronchodilator FEV1 is 50% or less than the predicted value

          3. Former smokers or current smokers with at least a 10 pack-year history

          4. A history of exacerbation (scheduled/unscheduled visits to primary care physicians,
             specialists or allied healthcare professionals, or emergency room, or hospitalization
             due to purulent sputum or increased sputum, or increased dyspnea) in the previous year
             (at least one)

          5. Chronic bronchitis (cough and sputum production for at least three months within two
             years)

          6. Able to have the signed written informed consent prior to any study-related
             procedures.

        Exclusion Criteria:

          1. COPD exacerbation or respiratory infection 4 weeks prior to the baseline visit

          2. Known a1-antitrypsin deficiency

          3. Need for long-term oxygen therapy

          4. Moderate to severe liver impairment (Child-Pugh B or C)

          5. Severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus
             erythematosus, etc)

          6. Severe acute infectious diseases

          7. Cancers

          8. Subjects being treated with immunosuppressive medicinal products (i.e.: methotrexate,
             azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term)
             except short-term systemic corticosteroids)

          9. Latent infections such as tuberculosis, viral hepatitis, herpes viral infection and
             herpes zoster

         10. Subjects with congestive heart failure (NYHA grades 3 and 4)

         11. Subjects with a history of depression associated with suicidal ideation or behavior

         12. Clinically meaningful bronchiectasis

         13. Pregnancy or breast feeding, or Female subjects of childbearing potential unwilling to
             use effective contraception

         14. Patients with known hypersensitivity to Roflumilast or rescue medication and their
             ingredients

         15. Patients with previous Roflumilast therapy within past 3 months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.


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