Clinical trial: Mannitol Dose Response Study in Cystic Fibrosis (NCT00251056)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of cystic fibrosis (sweat test/genotype)

          -  7 years or older

          -  FEV1 between 40% and 90% of predicted for height, age and gender.

          -  Able to perform acceptable-quality spirometry

          -  Clinically stable in the week up to study entry

          -  No additional antibiotics or additional oral steroids for a period of 14 days before
             study entry (routine antibiotics permitted)

        Exclusion Criteria

          -  Currently active asthma

          -  Subjects colonized with Burkholderia cepacia or MRSA

          -  Considered "terminally ill" or listed for transplantation

          -  Requiring home oxygen or assisted ventilation

          -  Concurrent illness that in the investigators opinion may contribute to an increased
             and unacceptable risk if the subject was enrolled in the study (e.g. significant
             varicies, portal hypertension, cor pulmonale)

          -  Significant episode of haemoptysis (>60 mLs) in the previous 12 months

          -  Heart attack or stroke in last 3 months

          -  Known aortic or cerebral aneurysm

          -  Subjects who are breast feeding or pregnant.

          -  At risk females unwilling to use appropriate contraception to prevent pregnancy during
             the course of the study

          -  Subjects who have participated in another investigative drug study parallel to, or
             within 4 weeks of study entry.

          -  Known intolerance to mannitol or unable to take any form of bronchodilator
             medications.

          -  Uncontrolled hypertension, systolic BP > 200 or diastolic BP> than 100

          -  Concurrent use of beta blocker medication

          -  Concurrent use of hypertonic saline

        Canada:

          -  Concurrent use of other pharmacological mucolytic agents other than Pulmozyme

        Argentina:

          -  Concurrent use of other pharmacological mucolytic agents including Pulmozyme
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 7 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? 1