Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Rebecca Haydock
+44 (0)115 8231575
fourfold@nottingham.ac.uk


Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - FAST - four-fold asthma study: the clinical and cost effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations
Back

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

Not Recruiting

Open to: All Genders

Age: Adult

13.9 Mile Away
Liverpool Leicester Newcastle Blackpool Aberdeen Manchester Nottingham Sutton-in-Ashfield Liverpool Liverpool $location.addressLine3

Medical Conditions

Respiratory (asthma)

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 May 2013 31 Jan 2016

Publications

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27737713 protocol2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29504499 results2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30520413 results

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.


Men and women age 16 and over who have asthma and have been prescribed an inhaled steroid

You can take part if:



You may not be able to take part if:


Potential participants will be excluded on the basis of:1. History more in keeping with smoking related chronic obstructive pulmonary disease [COPD] (smoked > 20 pack years, without evidence of significant reversibility and eosinophilia)2. On maintenance oral steroids (i.e. step 5 BTS/SIGN guidelines)3. Using a combination inhaler for both maintenance and relief treatment4. Experienced an exacerbation within 4 weeks of randomisation5. Pregnant women, lactating women or women who are planning to become pregnant


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Arrowe Park Hospital
    Liverpool
    CH49 5PE
  • Glenfield Hospital
    Leicester
    LE3 9QP
  • Freeman Hospital
    Newcastle
    NE7 7DN
  • Blackpool Victoria Hospital
    Blackpool
    FY3 8NR
  • Aberdeen Royal Infirmary
    Aberdeen
    AB25 2ZN
  • University Hospital of South Manchester
    Manchester
    M23 9LT
  • Nottingham University Hospitals
    Nottingham
    NG7 2UH
  • King’s Mill Hospital
    Sutton-in-Ashfield
    NG17 4JL
  • Aintree University Hospital
    Liverpool
    L9 7AL
  • Royal Liverpool and Broadgreen Hospital
    Liverpool
    L7 8XP

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

Ms Rebecca Haydock
+44 (0)115 8231575
fourfold@nottingham.ac.uk



The study is sponsored by University of Nottingham (UK) and funded by Health Technology Assessment Programme.



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN15441965

Or CPMS 14257

Last updated 11 December 2018

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top