Clinical trial: mRNA and miRNA Airway Inflammatory Markers (NCT03924843)

Eligibility criteria:
Inclusion Criteria:

          -  Men/Women age >40 years.

          -  Diagnoses of COPD according to criteria of the American Thoracic Society (ATS), a
             disease state characterized by the presence of chronic airway obstruction due to
             chronic bronchitis (cough/sputum on most days a week for 3 months in a year for at
             least two successive years) and/or emphysema

          -  Diagnosis of moderate or severe COPD exacerbation (see "Definitions")

          -  FEV1 > 0.8 L and ability to produce sputum after hypertonic saline production

          -  Post bronchodilator FEV1/Forced Vital Capacity (FVC) ratio <70 % and post
             bronchodilator FEV1< 80% pred.

          -  A smoking history of >10 pack years

        Exclusion Criteria:

          -  Pneumonia as determined by X-ray

          -  > 48 h intake of prednisolon/antibiotics

          -  Need for mechanical ventilation (either invasive or non-invasive)

          -  Treatment with immune-modulating agents for any disease

          -  Experimental interventions for COPD last half year

          -  Former/concomitant diagnosis of asthma

          -  Any significant other pulmonary disease or disorder

          -  Other significant disease or disorder (like alpha-1-antitrypsine deficiency,
             significant bronchiectasis, cardiovascular, gastrointestinal, liver, renal,
             neurological, musculoskeletal, endocrine, metabolic (including diagnosed diabetes),
             malignant, psychiatric, major physical impairment), which, in the opinion of the
             investigators may either put the patient at risk because of participation in the
             study, or may influence the results of the study, or the patient's ability to
             participate in the study.

          -  Existing pregnancy/ current willingness for becoming pregnant
No condition on gender to be admitted to 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