Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
06/10/2011
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 Andrew M Jones

ORCID ID

Contact details

The Manchester Adult Cystic Fibrosis Centre
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 0161 291 2154
andrew.jones@uhsm.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226167746

Study information

Scientific title

Acronym

Study hypothesis

To compare whether changing oxygen flow or oxygen percentage through a fixed performance mask relieves breathlessness in patients with cystic fibrosis.

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

Nutritional, Metabolic, Endocrine: Cystic fibrosis

Intervention

Cohort of stable CF Patients. Patients will perform a maximal bicycle ergometric exercise test on room air (under supervision of a specialist CF physiotherapist and doctor) to determine work rate & associated peak respiratory flow rate. VAS is assessed each minute to specifically determine degree of breathlessness. Following the exercise test VAS is assessed in recovery.

Patients are rested and randomly assigned one of three exercise tests over two days. These exercise tests use either an increasing oxygen concentration mask (flow rate remains the same). Relief of breathlessness will be determined by VAS scoring.

Added Seyember 2008: trial stopped due to lack of resources.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Increasing oxygen flow rate is beneficial to breathless patients

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2005

Overall trial end date

30/12/2007

Reason abandoned

Lack of resources

Eligibility

Participant inclusion criteria

1. Cystic fibrosis patients aged over 16
2. Clinically stable
3. Able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

20 patients to be recruited from the Manchester Adult Cystic Fibrosis Unit.

Participant exclusion criteria

Patients having respiratory exacerbation

Recruitment start date

01/07/2005

Recruitment end date

30/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Manchester Adult Cystic Fibrosis Centre
Manchester
M23 9LT
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

South Manchester University Hospitals NHS Trust (UK), 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