Clinical trial: Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder (NCT01168895)

Eligibility criteria:
Inclusion Criteria:

          -  Adult subjects with COPD, 40 - 75 years of age

          -  All subjects must have a diagnosis of COPD and must have airway obstruction with a
             post-bronchodilator Forced Expiratory Volume in 1 sec (FEV1) of >/= 30% and <= 80% of
             predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of </= 70%

          -  Subjects must be current or ex-smokers with a smoking history of more than 10
             pack-years

          -  Subjects must be able to perform technically acceptable pulmonary function tests
             during the study period as required in the protocol

          -  Subjects must be able to produce an sufficient amount of sputum during sputum
             induction at screening

        Exclusion Criteria:

          -  Subjects with a significant respiratory disease other than COPD.

          -  Exacerbation within 8 weeks prior to screening

          -  Subjects with more than 1 COPD exacerbation within 12 months prior to screening

          -  Subjects must have an FEV1 of at least one Liter

          -  Subjects with a history or physician's diagnosis of asthma. If a patient has a total
             blood eosinophil count >/= 0.6 x 10^9/L source documentation is required to verify
             that the increased eosinophil count is related to a non-asthmatic condition.

          -  Subjects with hypersensitivity to the ciprofloxacin or to other quinolones and/or to
             inactive constituents of the inhalation powder

          -  Subjects with known hypersensitivity of the bronchial system to inhalation of
             nebulized drugs or saline solution

          -  Subjects with a history of cystic fibrosis

          -  Subjects with clinically evident bronchiectasis

          -  Subjects taking any:

               -  Oral beta-adrenergic drugs or non cardioselective beta blockers,

               -  Oral glucocorticoids,

               -  Antihistamines or antileukotrienes prescribed for asthma,

               -  Oral cromolyn sodium or oral nedocromil sodium,

               -  Concomitant inhalative therapy with antibiotics and / or concomitant systemic
                  therapy with fluoroquinolones
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 75 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