FAST - four-fold asthma study: the clinical and cost effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations

Plain English summary of protocol

Background and study aims
Many people with asthma take regular inhaled steroids. These are either given alone or as part of a combination treatment. Despite regular treatment with inhaled steroids, some patients continue to have periods of poor asthma control, which are called exacerbations. Exacerbations often require treatment with steroid tablets and can lead to time away from school or work. Previous asthma guidelines have advised patients to double their dose of inhaled steroid at the first sign of a cold or worsening asthma symptoms, which has been shown not to work. A recent study has shown that increasing the dose to four times the normal dose for a short time may help in preventing an exacerbation but this is not certain. This study would like to test this by comparing a modified self-management plan to the one used in clinical care at the moment. This modified plan recommends taking four times the normal dose of inhaled corticosteroid when participant's asthma control starts to get worse.

Who can participate?
Men and women age 16 and over who have asthma and have been prescribed an inhaled steroid

What does the study involve?
If patients are interested in taking part, an appointment is made for them to visit the clinic, where they can have a chat about the study and answer any questions. If patients are still interested in taking part they need to sign a consent form and then some details are recorded about them. Participants also be asked to complete three short questionnaires and have their peak flow (maximum speed of expiration) measured. To find out which self-management plan is best and to avoid any bias, participants are not able to choose which plan they receive, instead they are allocated one of the two plans (asthma self-management plan which includes an increase in inhaled corticosteroid or the same plan without an increase in inhaled corticosteroid) by chance. The self-management plan advises participants what to do if their asthma gets worse. Participants also receive a diary card and training about how and when to complete this. At some sites, participants may be asked if they can attach an electronic device to one of their inhalers to count how many puffs of the inhaler they take. Participants need to come back to the clinic at 6 and 12 months after they start the study. During these visits the study team review and discuss their asthma self-management plan and participants are asked to complete several short questionnaires asking about their quality of life and use of NHS services. This should take no longer than 45 minutes. In addition, if the participant's asthma starts to get worse during the study and they move into Zone 2 of their self-management plan, participants need to start to complete the diary card and to make an appointment to come into the clinic 14 days later. At this visit a member of the research team reviews their diary card and discusses their asthma self-management plan. Participants are also asked to complete a short quality of life questionnaire. The research team sends a text message to the participants every month to remind them about their self-management plan. Participants remain on their own regular asthma medication throughout the study as part of their self-management plan.

What are the possible benefits and risks of participating?
If the participants do not usually use a self-management plan their asthma control may improve during the study. There is a chance that they may develop oral thrush or a hoarse voice if their self-management plan recommends extra inhaled steroid. The risk of this can be reduced by rinsing their mouth after using their steroid inhaler and it usually resolves spontaneously once the dose is reduced again. If not it is easily treated with antifungal throat lozenges or liquid prescribed by their doctor

Where is the study run from?
Nottingham Clinical Trials Unit (UK)

When is the study starting and how long is it expected to run for?
May 2013 to August 2017

Who is funding the study?
NIHR Health Technology Assessment Programme (UK)

Who is the main contact?
Rebecca Haydock
fourfold@nottingham.ac.uk

Contact information

Ms Rebecca Haydock
Scientific

Nottingham Clinical Trials Unit
Nottingham Health Science Partners
Queen's Medical Centre
Derby Road
Nottinghamshire
Nottingham
NG7 2UH
United Kingdom

ORCID ID	0000-0001-6291-8069
Phone	+44 (0)115 8231575
Email	fourfold@nottingham.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom

Study participating centres

Sponsor information

University of Nottingham (UK)
University/education

c/o Angela Shone
Research Innovation Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom

Website	http://www.nottingham.ac.uk/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

11/12/2018: Publication reference added.
16/03/2018: Publication reference added.
05/10/2017: Publication and dissemination plan and IPD sharing statement.
03/10/2017: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/08/2016 to 31/08/2017.
2. The target number of participants was changed from 1773 to 1774.
17/10/2016: Publication reference added.
23/06/2015: The target number of participants was changed from 2300 to 1773.