Effect of Non-Invasive Ventilation in Cystic Fibrosis Patient With Chronic Respiratory Failure.

Phase 4

Terminated

• Conditions: Cystic Fibrosis; Chronic Respiratory Failure
• Interventions: Device: pressure support ventilator

• Registration Number: NCT00208078
• Lead Sponsor: Cochin Hospital

Brief Summary

There is no randomised controlled trials to determine the clinical effects of long term Non-Invasive Ventilation in Cystic Fibrosis patients.

Detailed Description

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2010-05
• Study Completion: 2011-05
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Confirmed diagnosis of Cystic fibrosis
• Chronic hypercapnia on room air in stable condition (PaCO2 between 45 and 55mmHg in two occasions separated by more than 4 weeks)
• Informed consent

Exclusion Criteria

• Current treatment with non-invasive ventilation
• PaCO2 more than 55 mmHg
• Recent pneumothorax (within past 3 months)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-invasive ventilation	pressure support ventilator	Pressure support ventilator (SAIME,AIROX)

Primary Outcome Measures

Name	Time	Method
The effect of non-invasive ventilation on room air PaCO2 at one year: Hypothesis is PaCO2 stabilisation in the non-invasive ventilation group compared to a increase in PaCO2 in the control group (standard treatment)	ended 2011

Secondary Outcome Measures

Name	Time	Method
Effects of non-invasive ventilation on dyspnea index, functional status (6 minutes walking test, spirometric values), pulmonary exacerbations and body mass index (BMI) compared to standard treatment.	ended 2011

Trial Locations

Locations (1)

Department of pulmonary disease of Cochin Hospital (AP-HP); 🇫🇷 Paris, France