Background
Objectives
Methods/design
Participants, interventions and outcomes
Setting
Eligibility
Inclusion criteria
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Male or female patients aged 16 years and over
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Clinician-diagnosed asthma treated with a licensed dose of inhaled corticosteroid (i.e. steps 2 to 4 of the British Thoracic Society/Scottish Intercollegiate Guidelines Network (BTS/SIGN) guidelines)
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One or more asthma exacerbation in the last 12 months requiring treatment with systemic corticosteroids
Exclusion criteria
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A history more in keeping with smoking-related chronic obstructive pulmonary disease (COPD) (smoked more than 20 pack years, without evidence of significant reversibility and an absence of eosinophilia)
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On maintenance orally administered corticosteroids (i.e. step 5 of the BTS/SIGN guidelines)
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Using a combination inhaler for both maintenance and relief treatment
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Experienced an asthma exacerbation within 4 weeks of randomisation
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Pregnant women, lactating women or women who are planning to become pregnant
Interventions
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In the modified (quadrupling) group:
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∘ poor – no or minimal change in medication
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∘ moderate – change but not as fourfold or instructed
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∘ good – fourfold change and followed instructions
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In the usual care (no change) group:
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∘ poor – fourfold increase in maintenance dose
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∘ moderate – increase in maintenance dose but less than fourfold
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∘ good – no change in inhaled corticosteroid dose
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Outcomes
Participant timeline
Protocol | Date | Summary of protocol changes |
---|---|---|
V 2.0 | 5 Aug 2013 | • Minor wording added to the protocol to clarify that potential participants can be recruited from clinic appointments in primary care |
V 3.0 | 23 Oct 2013 | • Table 3 – How to achieve a quadrupling dose for participants on a combination inhaler • Clarification of the dose strength for Symbicort • Clarification of inhaler type • The addition of a new dose of Fostair and QVAR • Clarification of a typographic error |
V 4.0 | 3 Feb 2014 | • Clarification of serious adverse event reporting timeframe |
V 5.0 | 14 Oct 2014 | • Use of the current approved advert to be placed on public notice boards, universities and on websites and social media • Use of DocMail in GP practices • Telephone consultation at 6 and 12 months if patient has not had an exacerbation |
V 6.0 | 5 Nov 2015 | • Additional wording to the sample size justification section of the protocol, reduction of sample size from 2300 to between 1774 and 1850, removal of paragraph and references pertaining to electronic dose counters (Smart-inhalers) and other minor typographic clarifications |