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ISRCTN
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ISRCTN84977419
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ClinicalTrials.gov identifier
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Public title
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A prospective randomised cross-over trial to examine the effect of auto variable positive airway pressure versus standard non-invasive positive pressure ventilation on stable chronic obstructive pulmonary disease-patients previously established on non-invasive ventilation
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Scientific title
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Acronym
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N/A
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Serial number at source
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P01033
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Study hypothesis
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Auto Variable Positive Airway Pressure (AutoVPAP) is not as efficacious as Non-Invasive Positive Pressure Ventilation (NIPPV).
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Lay summary
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Ethics approval
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Approved by Huntingdon Research Ethics Committee (REC) on 5/09/2006 (reference number: 05/Q0104/118).
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Study design
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Randomised crossover trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chronic Obstructive Pulmonary Disease (COPD)
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Participants - inclusion criteria
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1. Chronic Obstructive Pulmonary Disease (COPD)
2. Forced Expiratory Volume in One second (FEV1) more than 50% predicted value
3. Smoking history more than 20 pack years
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Participants - exclusion criteria
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1. Aged over 80 years
2. No other significant lung disease
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Anticipated start date
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15/12/2005
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Anticipated end date
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15/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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25
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Interventions
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AutoVPAP versus NIPPV
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Primary outcome measure(s)
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Nocturnal oxygenation
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Secondary outcome measure(s)
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Quality of life
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Sources of funding
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ResMed
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Trial website
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Publications
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1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20546195
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Contact name
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Dr
Nick
Oscroft
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Address
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Papworth Hospital
Papworth Everard
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City/town
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Cambridge
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Zip/Postcode
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CB3 8RE
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Country
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United Kingdom
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Tel
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+44 (0)1480 364495
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Fax
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+44 (0)1480 831450
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Email
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nick.oscroft@papworth.nhs.uk
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Sponsor
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Papworth Hospital NHS Foundation Trust (UK)
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Address
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Papworth Hospital
Papworth Everard
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City/town
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Cambridge
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Zip/Postcode
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CB3 8RE
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Country
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United Kingdom
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Date applied
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03/08/2006
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Last edited
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14/12/2010
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Date ISRCTN assigned
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31/08/2006
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