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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00208078 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Non-Invasive Ventilation in Cystic Fibrosis Patient With Chronic Respiratory Failure.
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Scientific title:
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Evaluation of the Effects of Long Term Non-Invasive Ventilation in Patient With Cystic Fibrosis and Chronic Hypercapnic Respiratory Failure. |
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Date of first enrolment:
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May 2005 |
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Target sample size:
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36 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00208078 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Pierre-Régis Burgel |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of pulmonary disease of Cochin Hospital (AP-HP) |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Chronic Respiratory Failure
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Intervention(s)
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Device: pressure support ventilator
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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2206/08-11-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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