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

This study has been terminated.
(Not enough patient recruited)
Sponsor:
Information provided by (Responsible Party):
Dr Pierre-Régis Burgel, Cochin Hospital
ClinicalTrials.gov Identifier:
NCT00208078
First received: September 13, 2005
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Cystic Fibrosis
Chronic Respiratory Failure
 Device: pressure support ventilator
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Long Term Non-Invasive Ventilation in Patient With Cystic Fibrosis and Chronic Hypercapnic Respiratory Failure.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cochin Hospital:

Primary Outcome Measures:
  • 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) [ Time Frame: ended 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: ended 2011 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: May 2005
Study Completion Date: May 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual medical therapy
Usual CF care
Experimental: Non-invasive ventilation
Pressure support ventilator (SAIME,AIROX)
 Device: pressure support ventilator
Non invasive ventilation 4h/d 5 days a week

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208078

Locations
France
Department of pulmonary disease of Cochin Hospital (AP-HP)
Paris, France, 75679
Sponsors and Collaborators
Cochin Hospital
Investigators
Principal Investigator: Pierre-Régis Burgel Department of pulmonary disease of Cochin Hospital (AP-HP)
  More Information

Publications:

Responsible Party: Dr Pierre-Régis Burgel, Professor, Cochin Hospital
ClinicalTrials.gov Identifier: NCT00208078     History of Changes
Other Study ID Numbers: 2206/08-11-04
Study First Received: September 13, 2005
Last Updated: February 12, 2013
Health Authority: France: Ministry of Health

Keywords provided by Cochin Hospital:
Hypercapnia
Non-Invasive Ventilation

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Hypoventilation
Respiratory Insufficiency
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013