Condition category
Respiratory
Date applied
23/05/2005
Date assigned
08/07/2005
Last edited
16/07/2010
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

Dr Nick Oscroft

ORCID ID

Contact details

Papworth Hospital NHS Trust
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
+44 (0)1480 830541

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04/Q0104/139 - NRR Publication ID: N0542155456

Study information

Scientific title

Acronym

Study hypothesis

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic Obstructive Pulmonary Disease (COPD)

Intervention

Comparison of withdrawing long term NIPPV treatment or continuing

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

'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

Secondary outcome measures

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

Overall trial start date

16/05/2005

Overall trial end date

31/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

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)

Recruitment start date

16/05/2005

Recruitment end date

31/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Papworth Hospital NHS Trust
Cambridge
CB3 8RE
United Kingdom

Sponsor information

Organisation

Papworth Hospital NHS Trust (UK)

Sponsor details

Papworth Everard
Cambridge
CB3 8RE
United Kingdom
+44 (0)1480 830541
diane.bilton@papworth.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Respiratory Support and Sleep Centre Trust fund supported by an unrestricted grant from B & D Electromedical (UK)

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20397811

Publication citations

  1. Results

    Oscroft NS, Quinnell TG, Shneerson JM, Smith IE, The effects of withdrawing long-term nocturnal non-invasive ventilation in COPD patients., COPD, 2010, 7, 2, 111-116, doi: 10.3109/15412551003631725.

Additional files

Editorial Notes