Clinical trial: Induced Sputum Study (0000-065) (NCT00623714)

Eligibility criteria:
Inclusion Criteria:

          -  Patient has a history of mild to moderate persistent allergic asthma for at least 6
             months with typical symptoms, including cough, wheezing, and shortness of breath, is
             clinically stable and has no history of recent respiratory tract infection within 3
             weeks of the start of the study

          -  Patient, aside history of asthma, is judged to be in good health based on medical
             history, physical examination, vital sign measurements, and laboratory safety tests.

          -  Patient is able to perform reproducible pulmonary function test.

          -  Patient has an allergic response to house dust mite allergen, demonstrates a positive
             early and late phase response to an inhaled allergen challenge (as defined by a
             bronchoconstrictive response)

          -  Patient is a nonsmoker for at least 12 months. Patients must have less than or equal
             to 10 pack years of smoking to be included. (10 pack years = one pack per day for 10
             years.) Patients who have discontinued smoking for at least 10 months may be enrolled
             at the discretion of the investigator

          -  Patient is willing to avoid strenuous physical activity (i.e., strenuous or
             unaccustomed weight lifting, running, bicycling, etc.) for 72 hours prior to each
             visit when laboratory safety tests are obtained and 48 hours prior to allergen
             challenge

        Exclusion Criteria:

          -  Patient has a history of any illness that, in the opinion of the study investigator,
             might confound the results of the study or poses additional risk to the patient by
             their participation in the study

          -  Patient has taken oral corticosteroids within 8 weeks or inhaled corticosteroids/nasal
             corticosteroids within 4 weeks of screening and/or during the study

          -  Patient has a history of stroke, chronic seizures, or major neurological disorder

          -  Patient has a history of clinically significant endocrine, gastrointestinal,
             cardiovascular, hematological, hepatic, immunological, renal, respiratory (other than
             asthma), or genitourinary abnormalities or diseases, or has a history of neoplastic
             disease

          -  Patient is unable to refrain from or anticipates the use of any medication other than
             the ones permitted in this study, including prescription and non-prescription drugs or
             herbal remedies prior to administration of the initial dose of study drug, throughout
             the study (including washout intervals between treatment periods), until the poststudy
             visit

          -  Patient consumes excessive amounts of alcohol, defined as greater than 3 glasses of
             alcoholic beverages per day or >21 drink equivalents per week.

          -  Patient consumes excessive amounts, defined as greater than 6 servings of coffee, tea,
             cola, or other caffeinated beverages per day
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 55 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