A study to test the efficacy of the Mag-Flo inhaler tuition device
| ISRCTN | ISRCTN16154048 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16154048 |
| Secondary identifying numbers | N0265160802 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 01/05/2008
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr MR Miller
Scientific
Scientific
Respiratory Medicine
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To test whether a group of subjects who have been taught how to use their inhaler and then trained with the Mag-flo device can perform the inhalation better than a group only receiving the usual training instruction. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory: Asthma/COPD |
| Intervention | Fyne-Dynamics will supply conventional Mag-Flo devices for patient use. They will also supply special research devices that tog how long the inhalation lasted with flows between 30 and 60 L/min once triggered and also log the total time of the inhalation following the trigger. The operator marks electronically when the subject starts the breath in sc the time to achieve the trigger flow cart be estimated, The research devices can operate with the green light blanked out (blinded) so the training prompt from the device is not evident to the user when testing how good they are. The patients involved will be undergoing inhaler tuition as part of their NHS treatment and so no extra patient activity is involved. Design Patients will be randomised into one of two Groups. The study will be unblinded. Objective measures will be made with no operator rejection of data. Group 1 will receive standard tuition on how to use their inhaler and will have their ability to perform the manoeuvre documented at the beginning and the end of this initial training. They wilt also be tested 8 weeks fat or using a blinded Mag-Flo device. Group 2 will receive tuition on bow to use their inhaler and will use the Mag-Flo device in their training, having been told that obtaining the correct flow using the Mag-Flo device is crucial for drug delivery. They will have their ability checked at the beginning and the end of this training. They will take a Mag-Flo home to use as often as they can to check and help train them in the manoeuvre. They will return in 8 weeks and be assessed again with the blinded device. Measurements The Mag-Flo device will be used to record 5 inhalations. The total duration of the inhalation and the duration of inhalation in the optimum low range will be recorded. During this assessment of the subjects ability the green light will not be operative in order to check the technique with the subject blinded. The mean duration of the best (i.e. longest time of inhalation in the correct flow range) two attempts writ be analysed as well as the mean and standard deviation of all 5 attempts. Spirometry to record PD/I, FVC and REF wilt he performed by technicians blind to he subjects grouping and will be according to British Thoracic Society guidelines before and 20 minutes after inhaling their prescribed dose of inhaler drug. Patients will fill in a satisfaction questionnaire about their perception of the device and how they got on with their inhaler. Protocol 1. Patients attend having desisted from any bronchodilator inhaler therapy as per routine laboratory practice and will have their spirometry recorded, 2. They are instructed an how to use the powder inhaler and with a blinded Mag-Flo the duration of satisfactory flow v/ill be measured on 5 separate attempts. 3. Group 1 subjects will have further tuition on how to optimise the use of the inhaler and at the end of the test session the duration of satisfactory flow will be measured again with a blinded Mag-Flo on 5 separate attempts, of which the first ones are used to deliver the active drug. 3.Group 2 subjects will have further tuition en hew to optimise the use of the inhaler using an active Mag-Flo as a guide tothe importance of achieving the right tow. At the end of the test session the duration of satisfactory flow will be measured again no 5 separate attempts, of which the first ones are used to deliver the active drug. 4. Record spirometry 20 minutes later. 5. Group 1 subjects leave to se their inhaler as prescribed. 5. Group 2 subjects leave with an active Mag-Flo to have at hems to help them monitor and learn bow to achieve the correct flow when using their inhaler as prescribed. 6. Subjects return in 5 weeks and have their spiromety recorded having desisted from any bronchodilatar inhalers |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Measurements: the Mag-Flo device will be used to record 5 inhalations. The total duration of the inhalation and the duration of inhalation in the optimum low range will be recorded. During this assessment of the subjects ability the green light will not be operative in order to check the technique with the subject blinded. The mean duration of the best (i.e. longest time of inhalation in the correct flow range) two attempts writ be analysed as well as the mean and standard deviation of all 5 attempts. Spirometry to record PD/I, FVC and REF wilt he performed by technicians blind to he subjects grouping and will be according to British Thoracic Society guidelines before and 20 minutes after inhaling their prescribed dose of inhaler drug. Patients will fill in a satisfaction questionnaire about their perception of the device and how they got on with their inhaler. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 14/06/2005 |
| Completion date | 14/06/2008 |
| Reason abandoned (if study stopped) | So few patients at this Trust were being selected for powder inhaler devices due to cost. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Initially a total of 30 patients will be recruited. As of May 2008, trial stopped due to poor recruitment. |
| Key inclusion criteria | All outpatients referred by their clinician for inhaler training by staff at the Lung Investigation Unit at the Queen Elizabeth Hospital will be invited to partake in the study. Patients with a clinical diagnosis either of asthma or chronic obstructive pulmonary disease can be entered. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 14/06/2005 |
| Date of final enrolment | 14/06/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Respiratory Medicine
Birmingham
B29 6JD
United Kingdom
B29 6JD
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
University Hospital Birmingham NHS Trust (UK)
No information available
NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
