| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN16158695 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0220184922 |
| Public title | Use of 3-helium MRI scanning to determine efficacy of chest physiotherapy in cystic fibrosis |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Nutritional, Metabolic, Endocrine: Cystic fibrosis |
| Study hypothesis | To confirm the efficacy of chest physiotherapy in promoting airway mucus clearance in cystic fibrosis (CF). |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 60 patients will be randomised to one of 3 treatment modalities giving 20 subjects/cohort. Inclusion: patients with CF aged <5 years who are able to perform spirometry. |
| Participants - exclusion criteria | Patients undergoing a significant respiratory exacerbation sufficient to prevent lung function testing. |
| Patient information material |
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| Anticipated start date | 17/08/2006 |
| Anticipated end date | 31/05/2007 |
| Status of trial | Completed |
| Target number of participants | 60 |
| Interventions | 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 3 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. |
| Primary outcome measure(s) | Change in dynamic lung function as demonstrated by 3-helium MR scanning, post chest physiotherapy. |
| Secondary outcome measure(s) | Further demonstration of the use of 3-helium scanning to relate structural to functional change in the lung. |
| Sources of funding | Sheffield Children's NHS Foundation Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Prof C J Taylor |
| Contact details | Academic Unit of Child Health
Floor C, Stephenson Wing
Sheffield Children's NHS Foundation Trust
Western Bank
Sheffield
United Kingdom
S10 2TH |
| Contact telephone | +44 0114 271 7304 |
| Contact fax | +44 0114 272 3418 |
| Contact email | c.j.taylor1@sheffield.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN16158695 |
| Date last extracted from ISRCTN register | 17/04/2008 |
