Condition category
Respiratory
Date applied
15/09/2008
Date assigned
11/12/2008
Last edited
11/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.respironics.com

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

Publication citations

Additional files

Editorial Notes