Clinical trial: Human Safety of Capsaicin Inhalation Challenge Testing for Young and Older Men (NCT01621685)

Eligibility criteria:
Inclusion Criteria:

          1. Men of ages 18 and 30 (Dates of birth 1973-1985) or 55-92 years old (Dates of birth
             1911-1948).

          2. Must not currently be a cigarette smoker. If an ex-smoker then has not smoked for at
             least 10 years and consumption were no more than 10 pack years.

          3. Agrees to volunteers for the study and willing to sign the informed consent form.

          4. There were negative/normal screening tests for the following

               1. Responses to the questionnaire deny current and prior respiratory diseases
                  (including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung
                  d9sase) and no current respiratory complaints (e.g., cough, wheezing, shortness
                  of breath, allergic rhinitis, and sinusitis). Subjects must not be taking any
                  cardiac medications or admit to a physician-diagnosed cardiac condition.

               2. "Normal" spirometry measurements with FEV1 & FVC greater than 75% predicted and
                  FEV1/FVC more than 69%

               3. Impedance oscillometry were within normal limits

               4. "Negative" physical examination of the chest with absence of wheezing and
                  crackles on auscultation of the chest.

               5. Exhaled nitric oxide concentration is less than 35 ppb for younger and less than
                  65 ppb for older groups

        Exclusion Criteria:

          1. men of: ages < 18, 31-54 and >92 years old;

          2. current cigarette smokers or exsmokers who have smoked within the past 10 years and/or
             smoked more than 10 pack/years;

          3. refusal to volunteer for the study and not willing to sign the informed consent form;

          4. screening test not considered "normal" by physician/PI and showing one or more of the
             following:

               1. one or more positive response to the questionnaire(e.g., current or past
                  respiratory diseases including asthma, emphysema, chronic bronchitis, sinusitis
                  and interstitial lung disease; and/or; current respiratory complaints (e.g.,
                  cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis) and/or;
                  admitting to taking a cardiac medication and/or; or physician-diagnosed cardiac
                  condition (e.g., coronary heart disease, angina, myocardial infarction, valvular
                  heart disease, cardiomyopathy, etc.);

               2. Abnormal spirometry measurements (FEV1 &/or FVC <75% predicted and FEV1/FVC
                  <69%);

               3. "Positive" physical examination (performed by Physician/PI) with presence of
                  wheezing and/or crackles on auscultation of the chest;

               4. Impulse oscillometry >4 times normal limits;

               5. Exhaled nitric oxide of >35ppb for younger group and >65 ppb for older group. -
Male
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 92 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? 0