Condition category
Respiratory
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
21/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Indranil Chakravorty

ORCID ID

Contact details

Department of Respiratory Medicine
Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
+44 01438 314333 ext. 5869
indranil.chakravorty@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0107162719

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Quality of life

Patient information sheet

Condition

Respiratory: Asthma

Intervention

A randomised, controlled trial of a self-management protocol 'Action Plan' against conventional treatment, I patients who are admitted with an acute exacerbation of a COPD or a fter a visit to the OP clinic (with a history of admission within the last 6 months). All patients would undergo baseline spirometry with assessment of reversibility to salbutamol in order to diagnose COPD and exclude asthma.

Patients randomised to the intervention group would receive:
1. Education about the nature of disease, risk factors, progression, pathophysiology of exacerbations and basic principles of management
2. Smoking cession
3. Nutritional assessment
4. Physiotherapy advice on the potential for exercise and pulmonary rehabilitating
5. Respiratory assessment

21/09/2012: Please note that this trial was stopped due to a lack of funding.

Intervention type

Drug

Phase

Not Specified

Drug names

Salbutamol

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2005

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2005

Recruitment end date

01/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Respiratory Medicine
Stevenage
SG1 4AB
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Hertfordshire Hospitals Research and Development Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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