Condition category
Respiratory
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
01/05/2008
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 MR Miller

ORCID ID

Contact details

Respiratory Medicine
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265160802

Study information

Scientific title

Acronym

Study hypothesis

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

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

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

14/06/2005

Overall trial end date

14/06/2008

Reason abandoned

So few patients at this Trust were being selected for powder inhaler devices due to cost.

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

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.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

14/06/2005

Recruitment end date

14/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Respiratory Medicine
Birmingham
B29 6JD
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

University Hospital Birmingham NHS 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

Publication citations

Additional files

Editorial Notes