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Table 1 Summary of protocol amendments that impacted on trial design

From: FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations



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