Clinical trial: Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis (NCT00388505)

Eligibility criteria:
Inclusion Criteria:

          -  Confirmed diagnosis of cystic fibrosis

          -  Male and female patients at least 6 years of age at the time of screening.

          -  Forced expiratory volume in one second (FEV1) at screening must be at least 25% and
             less than or equal to 75% of normal predicted values for age, sex, and height based on
             Knudson criteria.

          -  Pseudomonas aeruginosa, a type of bacteria, must be present in a sputum/deep-throat
             cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to
             screening and in the sputum/ deep-throat cough swab culture at the screening visit.

          -  Able to comply with all protocol requirements.

          -  Clinically stable in the opinion of the investigator.

          -  Use of an effective means of contraception in females of childbearing potential.

          -  Provide written informed consent, Health Authority Portability and Accountability Act
             (HIPAA) authorization (where applicable), and assent (as appropriate) prior to the
             performance of any study-related procedure.

        Exclusion Criteria:

          -  History of sputum culture or deep-throat cough swab (or BAL) culture yielding
             Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to
             screening and/or sputum culture yielding B cepacia at screening.

          -  Coughing up more than 60 cc of blood from the respiratory tract at any time within 30
             days prior to study drug administration.

          -  Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

          -  Females who are pregnant (positive pregnancy test), lactating, or are planning to
             become pregnant during the study.

          -  History of hearing loss or chronic ringing in the ears deemed clinically significant
             by the investigator.

          -  Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study
             drug administration.

          -  Use of loop diuretics within 7 days prior to study drug administration.

          -  Use of any investigational treatment within 28 days prior to study drug
             administration.

          -  Initiation of treatment with chronic macrolide therapy, dornase alpha treatment or
             inhaled corticosteroids within 28 days prior to study drug administration (patients
             may be taking these therapies at the time of enrollment, but they must have initiated
             treatment more than 28 days prior to study drug administration).

        Other protocol-defined inclusion/exclusion criteria may apply
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.


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? Entailment