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ISRCTN
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ISRCTN00075564
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ClinicalTrials.gov identifier
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Public title
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A trial of withdrawal of nocturnal non-invasive positive pressure ventilation (NIPPV) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic ventilatory failure previously stable on nocturnal NIPPV
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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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04/Q0104/139 - NRR Publication ID: N0542155456
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Study hypothesis
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Currently it is unclear whether patients with severe COPD benefit from noninvasive positive pressure ventilation in the long term. There is divided opinion and evidence on whether this is a beneficial treatment and who might benefit. In performing this clinical trial of withdrawal of a non-proven treatment with close monitoring we plan to address the issue of whether of not the treatment does maintain the patients in a stable clinical state and improve their quality of life.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled 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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Pre-screening criteria:
1. Diagnosis of COPD: forced expiratory volume in 1 second (FEV1) <50% predicted, FEV1/forced vital capacity (FVC) ratio <70%, total lung capacity (TLC) >80% predicted
2. Smoking history >20 pack years
3. Prior to commencing NIPPV hypercapnic ventilatory failure with daytime PaCO2 >7.5 kPa with normal pH (7.35-7.45) or nocturnal PtcCO2 >9 kPa
4. On NIPPV for at least 3 months with compliance of >4 hours/day
5. Live within 40-mile radius of trust
Screening criteria:
1. Clinically stable - no increase in breathlessness, cough or sputum volume in 4 weeks between initial assessment and entry to trial
2. PaCO2 within +/-1 kPa of initial assessment
3. No change in spirometry (<15% or 200 ml) from initial assessment
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Participants - exclusion criteria
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1. Age over 80
2. Other significant respiratory disease (interstitial lung disease, asthma, bronchiectasis, neuromuscular or restrictive chest wall disorders)
3. Significant documented left ventricular dysfunction with Ejection Fraction <40%
4. Obstructive sleep apnoea with an apnoea/hypopnoea index of over 10, which is reversible by continuous positive airway pressure (CPAP)
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Anticipated start date
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16/05/2005
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Anticipated end date
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31/01/2007
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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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40
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Interventions
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Comparison of withdrawing long term NIPPV treatment or continuing
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Primary outcome measure(s)
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'Withdrawal Failure' as stipulated by preset criteria. The effect of withdrawal of NIPPV therapy on arterial blood gas analysis.
Criteria for Withdrawal Failure:
1. Daytime PaCO2 >9 kPa
2. Nocturnal PtcCO2 >10 on night study
3. Respiratory acidosis pH <7.35
4. Intolerable symptoms, including morning headache and drowsiness
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Secondary outcome measure(s)
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1. Assess the effect of withdrawal of NIPPV therapy on: quality of life using SF-36 and St George's respiratory questionnaire, exacerbation rates, hospital admissions, GP contact and requirements for treatment with antibiotics and steroids
2. Assess that if preset criteria are met, reinstitution of NIPPV therapy has positive effects
3. Measure changes to spirometric, mouth pressure data and exercise capacity
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Sources of funding
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Respiratory Support and Sleep Centre Trust fund supported by an unrestricted grant from B & D Electromedical (UK)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20397811
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Contact name
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Dr
Nick
Oscroft
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Address
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Papworth Hospital NHS Trust
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 830541
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Fax
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+44 (0)1480 364568
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Email
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Sponsor
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Papworth Hospital NHS Trust (UK)
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Address
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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 830541
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Fax
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+44 (0)1480 364568
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Email
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diane.bilton@papworth.nhs.uk
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Date applied
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23/05/2005
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Last edited
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16/07/2010
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Date ISRCTN assigned
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08/07/2005
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