Clinical trial: The Addition of Non-Invasive Ventilation To Airway Clearance Techniques In Adults With Cystic Fibrosis (NCT01885650)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of cystic fibrosis (confirmed by genotype or a sweat sodium concentration of
             >70mmol/l or sweat chloride of >60mmol/l)

          -  Sixteen years of age or over

          -  Patients admitted to the Royal Brompton Hospital with a pulmonary exacerbation of
             which is resolving. Patients will be considered for inclusion from day 7 of treatment
             to 3 days prior to discharge (as determined by a member of the cystic fibrosis medical
             team and have spirometric values within 20% of the mean of the last two stable
             recordings (at least 1 month apart)

          -  Patients with an established airway clearance regime that they have used for 3 months
             or more

        Exclusion Criteria:

          -  Current moderate haemoptysis (greater than streaking in the sputum)

          -  Current pneumothorax or history of pneumothorax in the 3 months prior to consideration
             for the study

          -  Current dependency on positive pressure support with airway clearance via the IPPB
             (Intermittent Positive Pressure Breathing) machine or NIV

          -  Previous history of spontaneous rib fractures

          -  Pregnancy

          -  Inability to give consent for treatment or measurement

          -  Current participation in another study

          -  If the patient requires more than 2 airway clearance sessions a day
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 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