Clinical trial: The Study for Evaluating Factors Relating to Daily Step Counts and Physical Activity in Japanese Patients With COPD. (NCT03642613)

Eligibility criteria:
Inclusion Criteria:

          1. Patients who have provided written informed consent for participation in this study

          2. Male and female patients aged at least 40 years at the time of enrolment who are given
             diagnosis of COPD by a physician*1

          3. Patients whose respiratory function test values after bronchodilators (FEV1, FVC, IC)
             are available*2

          4. Patients whose DLCO values and data on the presence/absence of emphysema by a chest CT
             scan are available*3

          5. Outpatients who are able to answer the questionnaires and start measurement with an
             activity meter within four weeks after informed consent and measure activities for 14
             consecutive days

               -  1: Guideline 12) should be referenced for the diagnostic criteria of COPD.

               -  2: Patients whose respiratory function test values after bronchodilators at the
                  time of enrolment or within three months prior to enrolment are available. For
                  patients on a bronchodilator as a long-term controller, respiratory function test
                  values after bronchodilator in the morning of the test are acceptable.

               -  3: This refers to patients who have undergone tests within past one year.

        Exclusion Criteria:

          1. Patients who have participated in any other interventional studies such as clinical
             trials within the past eight weeks

          2. Patients determined to be inappropriate to be enrolled in this study by investigators
             because they cannot comply with the procedures, limitations, and requirements of this
             study, or for other reasons.

          3. Patients with an exacerbation of COPDa within the past eight weeks a Exacerbation of
             COPD: Conditions with increased shortness of breath, increased cough and sputum,
             occurrence of chest discomfort/uneasiness or its intensification, and which require
             changes in treatment on disease stable state, excluding cases where there is any other
             precedent disease (heart failure, pneumothorax, pulmonary thromboembolism, etc.).

          4. Patients who require home oxygen therapy (excluding those who use it only during
             nighttime)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



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