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

Primary Purpose

Cystic Fibrosis, Chronic Respiratory Failure

Status

Terminated

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

pressure support ventilator

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Hypercapnia, Non-Invasive Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual medical therapy

Non-invasive ventilation

Arm Description

Usual CF care

Pressure support ventilator (SAIME,AIROX)

Outcomes

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.

Full Information

NCT ID

NCT00208078

First Posted

September 13, 2005

Last Updated

February 12, 2013

Sponsor

Cochin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00208078

Brief Title

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

Official Title

Evaluation of the Effects of Long Term Non-Invasive Ventilation in Patient With Cystic Fibrosis and Chronic Hypercapnic Respiratory Failure.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Terminated

Why Stopped

Not enough patient recruited

Study Start Date

May 2005 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cochin Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Chronic Respiratory Failure

Keywords

Hypercapnia, Non-Invasive Ventilation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual medical therapy

Arm Type

No Intervention

Arm Description

Usual CF care

Arm Title

Non-invasive ventilation

Arm Type

Experimental

Arm Description

Pressure support ventilator (SAIME,AIROX)

Intervention Type

Device

Intervention Name(s)

pressure support ventilator

Intervention Description

Non invasive ventilation 4h/d 5 days a week

Primary Outcome Measure Information:

Title

Time Frame

ended 2011

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre-Régis Burgel

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Paris

ZIP/Postal Code

75679

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

15502116

Citation

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.

Results Reference

background

PubMed Identifier

12804435

Citation

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

Results Reference

result

Learn more about this trial

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

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