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

NCT00208078 | Terminated Phase 4 DMC

• 1 other identifier: 2206/08-11-04
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cystic Fibrosis; Chronic Respiratory Failure

Keywords

Hypercapnia; Non-Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Usual medical therapy

NO INTERVENTION

Usual CF care

Non-invasive ventilation

EXPERIMENTAL

Pressure support ventilator (SAIME,AIROX)

Device: pressure support ventilator

Interventions

pressure support ventilator DEVICE

Non invasive ventilation 4h/d 5 days a week

Non-invasive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cochin Hospital: lead

Study Sites (1)

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

Paris, 75679, France

Location

Related Publications (2)

• 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. doi: 10.1164/rccm.200405-667OC. Epub 2004 Oct 22.

  PMID: 15502116 BACKGROUND

• Moran F, Bradley J. Non-invasive ventilation for cystic fibrosis. Cochrane Database Syst Rev. 2003;(2):CD002769. doi: 10.1002/14651858.CD002769.

  PMID: 12804435 RESULT

MeSH Terms

Conditions

Cystic Fibrosis; Hypercapnia

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre-Régis Burgel

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: AMBIG
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2011
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

FR (1)