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
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