Condition category
Respiratory
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
06/10/2011
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

Mr Nigel Clayton

ORCID ID

Contact details

University Hospital of South Manchester NHS Foundation Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 0161 291 2406
nigel.clayton@uhsm.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226184632

Study information

Scientific title

Acronym

Study hypothesis

1. Is a four minute wait required between transfer test measurements?
2. Does airflow obstruction influence the results?

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

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

Respiratory: Function tests

Intervention

Prospective review of pulmonary function tests for patients referred to the pulmonary function laboratory. Participants will be randomised into the order of performing the test. This will either be a one minute wait followed by a four minute wait, or a four minute wait followed by a one minute wait.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Whether the timing of subsequent TLco measurements influences the transfer factor measurement.

Secondary outcome measures

Whether the timing of subsequent TLco measurements influences the alveolar volume measurement.

Overall trial start date

01/09/2006

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

25 subjects from each of the following diagnostic groups:
a. Healthy volunteers (no lung disease)
b. Asthmatics (variable obstructive lung disease)
c. COPD (obstructive lung disease)
d. Fibrosis (restrictive lung disease)

Inclusion criteria:
1. Over 18 years of age
2. Subject must be able to understand and perform lung function test to national guidelines
3. Non or ex-smokers (>6 months)
4. Physician diagnosis of asthma, COPD or lung fibrosis

Participant type

Healthy volunteer

Age group

Adult

Gender

Not Specified

Target number of participants

25

Participant exclusion criteria

1. Haemoptysis of unknown origin
2. Pneumothorax
3. Unstable cardiovascular status (recent MI or PE)
4. Thoracic, abdominal or cerebral aneurysms
5. Recent eye surgery
6. Nausea and vomiting
7. Recent thoracic or abdominal surgical procedures
8. Involved in other studies with licensed drugs or methodology studies within last weeks

Recruitment start date

01/09/2006

Recruitment end date

01/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of South Manchester NHS Foundation Trust
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 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

University Hospital of South Manchester NHS Foundation Trust (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

Presented by Arshed Mehmood as a poster at the Association for Respiratory Technology and Physiology annual conference in 2009

Publication citations

Additional files

Editorial Notes