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

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00208078
• Other study ID #: 2206/08-11-04
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 12, 2013
• Start date: May 2005
• Est. completion date: May 2011

Study information

• Verified date: February 2013
• Source: Cochin Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• Cystic Fibrosis
• Fibrosis
• Respiratory Insufficiency

Intervention

Device:
• pressure support ventilator
Non invasive ventilation 4h/d 5 days a week

Locations

Country	Name	City	State
France	Department of pulmonary disease of Cochin Hospital (AP-HP)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Cochin Hospital

Country where clinical trial is conducted

France, 

References & 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. Epub 2004 Oct 22. — View Citation

Moran F, Bradley J. Non-invasive ventilation for cystic fibrosis. Cochrane Database Syst Rev. 2003;(2):CD002769. Review. Update in: Cochrane Database Syst Rev. 2007;(4):CD002769. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No