Contact information
Type
Scientific
Primary contact
Prof J L Pepin
ORCID ID
Contact details
Laboratoire Exploration Fonctionnelle Cardio-Respiratoire (EFCR)
RDC Haut
CHU Michallon Nord
BP 217
Cedex 09
Grenoble
38043
France
JPepin@chu-grenoble.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EAME06NIV01
Study information
Scientific title
Acronym
AVAPS-COPD
Study hypothesis
Long-term domiciliary non-invasive positive pressure ventilation (NPPV) with average volume assured pressure support (AVAPS) in subjects with chronic obstructive pulmonary disease (COPD) who remain hypercapnic following the application of NPPV for an acute exacerbation will improve daytime partial pressure of carbon dioxide (PCO2) and endothelial dysfunction.
Ethics approval
Ethics Committee for Protection of Human Subjects, Grenoble University Hospital (CHU de Grenoble) (ref: CPP08-RESP-1), approval pending as of 11/12/2008.
Study design
Randomised, parallel group pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic obstructive pulmonary disease (COPD)
Intervention
Treatment group will receive standard optimal care plus NPPV with AVAPS support, ventilatory support function that dynamically determines the pressure support level, which generates the target or control level of exhaled tidal volume by producing a gradual pressure change based on the preceding several breaths.
Control group will receive standard optimised care.
Total duration of interventions/follow-up: 1 year
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Daytime PCO2, measured by arterial blood gases at baseline, 1, 3, 6 months and 1 year
2. Endothelial dysfunction, measured by peripheral arterial tone (PAT) at baseline, 1, 3, 6 months and 1 year
Secondary outcome measures
1. Lung function, measured by spirometry, according to the joint recommendations of the ERS/ATS. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year
2. Dyspnoea, measured at rest by the Borg scale. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year.
3. Fatigue, measured by Fatigue Severity Scale (FSS). The FSS questionnaires contains nine statements that rate the severity of the subject's fatigue symptoms an a scale from 1 to 7. A total score of less than 36 suggests that the subject may not be suffering from fatigue, while a score of greater than or equal to 36 indicates excessive fatigue. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year.
4. Sleep quality, measured by polysomnography (PSG), including transcutaneous PCO2. At baseline, PSG will be performed in spontaneous breathing in order to characterise the abnormal respiratory events associated with COPD and identify obstructive sleep apnoea (OSA). Sleep and respiratory events will be recorded and scored manually according to standard criteria. REM hypoventilation will be scored when a progressive oxygen desaturation is associated with a sustained reduction in both flow and thoracic components of ventilation. During the same period, a constant or reduced respiratory drive (assessed by a reduction in respiratory effort as demonstrated by pulse transit time) should be observed without characteristic apnoeic or hypopnoeic episodes. At 3 months and 1 year, polysomnography will be done in spontaneous breathing or using non-invasive ventilation depending the arm of the study. Timepoints of assessment: baseline, 3 months and 1 year.
5. Objective sleepiness as measured by the Osler Test. This test consists of a 40 minutes sleep-resistance challenge conducted in a dark and quiet room. The subject will be asked to remain awake while reacting to a visual stimulus, which appears for 1 second every 3 seconds, by hitting a button. Sleep latency will be defined as the delay between the onset of the test and the moment corresponding to seven consecutive flashes (i.e. 21 seconds) without response. Fluctuations in vigilance and micro-sleep episodes will be quantified as the number of occasions that 3 to 6 consecutive flashes occur without response (i.e. 9 to 18 seconds without response of the patient). Timepoints of assessment: baseline, 1, 3, 6 months and 1 year.
6. Exercise capacity. At baseline a practice test will be performed at least one hour before the actual test. The highest 6-minute walk distance will be reported as the patient's 6-minute walk distance at baseline. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year.
7. Physical activity. This will be objectively measured using the Actiwatch®. The Actiwatch® measures activity with a piezo-electric accelerometer that records intensity, amount and duration of movement in all directions. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year.
8. Quality of life, measured using the validated French version of the St Georges Respiratory Questionnaire. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year.
9. Arterial stiffness, determined by pulse wave velocity (PWV). Timepoints of assessment: baseline, 1, 3, 6 months and 1 year.
10. Time in hospital over course of follow up period
Overall trial start date
01/11/2008
Overall trial end date
01/11/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, aged 50 - 80 years
2. Confirmed diagnosis of COPD according to the joint recommendations of the European Respiratory Society/American Thoracic Society (ERS/ATS)
3. Minimum of 48 hours without NPPV after using NPPV or invasive ventilation in hospital during an acute exacerbation of COPD
4. Persistent hypercapnia (partial pressure of carbon dioxide in the arterial blood [PaCO2] greater than or equal to 50 mmHg, but less than 65 mmHg with an arterial pH above 7.32) during room air spontaneous breathing
5. Able to follow instructions
6. Able to provide informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Actively smoking
2. Therapy with systemic steroids
3. Important concomitant chronic systemic diseases (i.e. chronic heart failure [left ventricular ejection fraction less than 45%], diabetes, infections, neoplasm, forms of sleep disordered breathing, etc)
4. Other chronic respiratory diseases (e.g., significant fibrothorax, bronchiectasis, cystic fibrosis)
Recruitment start date
01/11/2008
Recruitment end date
01/11/2010
Locations
Countries of recruitment
France
Trial participating centre
Laboratoire Exploration Fonctionnelle Cardio-Respiratoire (EFCR)
Grenoble
38043
France
Sponsor information
Organisation
Respironics International, Inc. (France)
Sponsor details
20 Rue-Jacques Daguerre
Rueil-Malmaison
Paris
92500
France
steven.coughlin@respironics.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Respironics International, Inc. (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary