Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
08/09/2014
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

Prof C J Taylor

ORCID ID

Contact details

Academic Unit of Child Health
Floor C
Stephenson Wing
Sheffield Children's NHS Foundation Trust
Western Bank
Sheffield
S10 2TH
United Kingdom
+44 (0)114 271 7304
c.j.taylor1@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0220184922

Study information

Scientific title

Acronym

Study hypothesis

To confirm the efficacy of chest physiotherapy in promoting airway mucus clearance in cystic fibrosis (CF).

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

Condition

Cystic fibrosis

Intervention

We have previously shown that 3-helium MRI scanning provides a reliable and reproducible means of imaging the chest of CF. The technique is well tolerated in children as young as 5 years and can show changes in both lung structure and function without exposing the subjects to the risks of radiation. We proposed to use 3-helium MRI scanning to demonstrate the efficacy of airway clearance techniques and to compare different types of chest physiotherapy. Children with CF attending the Regional CF Centre at Sheffield Children's Hospital will be recruited into an open study. 3-helium MRI scanning will be performed before and after a session of chest physiotherapy administered by a trained physiotherapist.
Subjects will be randomised to receive one of three different methods of airway clearance, all in routine use in this clinic.
Changes in the lung fields and dynamic changes in lung function will be assessed from the MR images using an established scoring system. Assignments will be performed by an independent observer blinded to the method of chest physiotherapy employed. Changes in MR score will be compared with conventional methods of lung function testing (spirometry) and the degree of change correlated with the patients' general condition (Shwachmann and Chrispin Norman scores) derived from their annual review data.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in dynamic lung function as demonstrated by 3-helium MR scanning, post chest physiotherapy

Secondary outcome measures

Further demonstration of the use of 3-helium scanning to relate structural to functional change in the lung

Overall trial start date

17/08/2006

Overall trial end date

31/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

60 patients will be randomised to one of three treatment modalities giving 20 subjects/cohort. Inclusion: patients with CF aged <5 years who are able to perform spirometry.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

Patients undergoing a significant respiratory exacerbation sufficient to prevent lung function testing.

Recruitment start date

17/08/2006

Recruitment end date

31/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Child Health
Sheffield
S10 2TH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health (UK)

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

Sheffield Children's NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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

Publication citations

Additional files

Editorial Notes