Clinical trial: Characterization of Aerosol Generation and Transport in the Human Lung (NCT01095627)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female subjects, aged 18 to 65 years.

          2. Physician diagnosis of mild intermittent allergic asthma (GINA I according to GINA
             guidelines9).

          3. Normal lung function parameters at baseline (FEV1 > 80 % of predicted)

          4. Non smoker or smokers with a history of less than 10 pack years with no smoking in the
             last 12 months.

          5. Able and willing to give written informed consent

          6. Women will be considered for inclusion if they are:

        not pregnant, as confirmed by pregnancy test, and not nursing of non-child bearing
        potential (i.e. physiologically incapable of becoming pregnant, including any female who is
        pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation,
        or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year
        prior to the screening visit) of childbearing potential and using a highly effective method
        of contraception during the entire study (vasectomized partner, sexual abstinence - the
        lifestyle of the female should be such that there is complete abstinence from intercourse
        from two weeks prior to the study until at least 72 hours after the end of the study -,
        implants, injectables, combined oral contraceptives, hormonal IUDs, or double-barrier
        methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm,
        sponge, and cervical cap)

        • Available to complete all study measurements

        Exclusion Criteria:

          1. History of lower respiratory tract infection four weeks prior to the informed consent
             visit.

          2. Past or present disease, which as judged by the investigator, may affect the outcome
             of this study. These diseases include, but are not limited to, cardiovascular disease,
             malignancy, hepatic disease, renal disease, hematological disease, neurological
             disease, endocrine disease or pulmonary disease (including but not confined to chronic
             bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).

          3. Regular intake of any prescribed or over the counter medication. Exceptions include
             paracetamol for pain relief, oral contraceptive medication, hormonal replacement
             therapy, dietary and vitamin supplements, and short acting beta mimetics (SABA) on as
             needed basis.

          4. Use of anti-inflammatory medication including systemic or inhaled corticosteroid
             within the last four weeks.

          5. Any history of life-threatening asthma, defined as an asthma episode that required
             intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic
             seizures.

          6. Conditions or factors, which would make the subject unlikely to be able to undergo
             methacholine challenge.

          7. Conditions which provide a contraindication for methacholine challenge testing such as
             uncontrolled arterial hypertension, known aortic aneurysm, myocardial infarction or
             stroke within three months prior to study, current use of cholinesterase inhibitor
             medication.

          8. Inability to perform acceptable-quality spirometry.

          9. History of drug or alcohol abuse.

         10. Participation in another clinical trial 30 days prior to enrolment.

         11. Suspected inability to understand the protocol requirements, instructions and
             study-related restrictions, the nature, scope, and possible consequences of the study.

         12. Risk of non-compliance with study procedures.
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 65 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