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

Sponsored by:	Cochin Hospital
Information provided by:	Cochin Hospital
ClinicalTrials.gov Identifier:	NCT00208078

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 (AIROX, SAIME)	Phase IV

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of the Effects of Long Term Non-Invasive Ventilation in Patient With Cystic Fibrosis and Chronic Hypercapnic Respiratory Failure.

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)

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.

Estimated Enrollment:	80
Study Start Date:	May 2005
Estimated Study Completion Date:	May 2008

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

Contacts

Contact: Pierre-Régis Burgel

(+33) 1.58.41.23.71

pierre-regis.burgel@cch.aphp.fr

Locations

France
Department of pulmonary disease of Cochin Hospital (AP-HP)	Recruiting
Paris, France, 75679
Contact: Pierre-Régis Burgel (+33) 1.58.41.23.71 pierre-regis.burgel@cch.aphp.fr
Principal Investigator: Pierre-Régis Burgel

Sponsors and Collaborators

Cochin Hospital

Investigators

Principal Investigator:

Pierre-Régis Burgel

Department of pulmonary disease of Cochin Hospital (AP-HP)

More Information

Publications of Results:

Moran F, Bradley J. Non-invasive ventilation for cystic fibrosis. Cochrane Database Syst Rev. 2003;(2):CD002769. Review.

Other Publications:

Ellaffi M, Vinsonneau C, Coste J, Hubert D, Burgel PR, Dhainaut JF, Dusser D. One-year outcome after severe pulmonary exacerbation in adults with cystic fibrosis. Am J Respir Crit Care Med. 2005 Jan 15;171(2):158-64. Epub 2004 Oct 22.

Study ID Numbers:	2206/08-11-04
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00208078
Health Authority:	France: Ministry of Health

Keywords provided by Cochin Hospital:

Hypercapnia
Non-Invasive Ventilation

Study placed in the following topic categories:

Hypercapnia
Fibrosis
Respiration Disorders
Hypoventilation
Signs and Symptoms
Respiratory Insufficiency
Digestive System Diseases
Cystic Fibrosis

Respiratory Tract Diseases
Genetic Diseases, Inborn
Lung Diseases
Signs and Symptoms, Respiratory
Pancreatic Diseases
Infant, Newborn, Diseases
Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009