Cystic Fibrosis Clinical Trial
Official title:
Evaluation of the Effects of Long Term Non-Invasive Ventilation in Patient With Cystic Fibrosis and Chronic Hypercapnic Respiratory Failure.
There is no randomised controlled trials to determine the clinical effects of long term Non-Invasive Ventilation in Cystic Fibrosis patients.
The effects of long term mechanical ventilation for the treatment of respiratory failure in
patients with neuromuscular diseases is well established.
Long term non-invasive ventilation is commonly used in the treatment of Cystic Fibrosis
patients with respiratory failure. However, the benefits of this treatment have never been
studied in randomized control trials and are unknown.
The goal of this multicenter study is to evaluate the effects of the addition of
non-invasive ventilation to the standard therapy in stable Cystic Fibrosis patients with
chronic hypercapnia.
Two groups of patients will be followed: The first group will receive standard treatment for
advanced Cystic Fibrosis according to international guidelines, the second group will
receive the same treatment plus non-invasive ventilation (4H/day). The follow up time will
be one year for each patient.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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