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. 2017 Jul 29;4(1):e000217. doi: 10.1136/bmjresp-2017-000217

Table 1.

Inclusion and exclusion criteria

Inclusion criteria Exclusion criteria
  • Adults aged 18–75 years

  • Self-report of a doctor’s diagnosis of asthma

  • Not used ICS in the 12 weeks prior to entry into the study and:

    • asthma symptoms or need for SABA ≥2 occasions in the last 4 weeks, or

    • waking due to asthma ≥ once in the last 4 weeks, or

    • exacerbation requiring oral corticosteroids in the last 52 weeks, or

  • used ICS in the 12 weeks prior to entry in the study, and prescribed ICS at low or moderate doses (≤500 µg/day fluticasone propionate or small particle formulation beclomethasone dipropionate (Qvar); ≤800 µg/day budesonide; ≤1000 µg/day beclomethasone dipropionate (Beclazone)), and

    • has partly or well-controlled asthma as defined by GINA guidelines, or

    • has uncontrolled asthma as defined by GINA guidelines and either poor adherence to ICS and/or unsatisfactory inhaler technique*

  • Willing and able to give informed consent for participation in the trial

  • In the investigator’s opinion, able and willing to comply with all trial requirements

  • Willing to allow their general practitioner (and specialist if appropriate) to be notified of participation in the trial

  • Self-reported use of LABA, leukotriene receptor antagonist, theophylline, anticholinergic agent or cromone as maintenance therapy in the 12 weeks before potential study entry; nasal corticosteroid therapy is permitted

  • Self-reported past admission to the intensive care unit with life-threatening asthma (representing patients at highest risk of adverse asthma outcomes)

  • Self-reported treatment with oral prednisone or other systemic corticosteroids in the 6 weeks before potential study entry (representing recent unstable asthma)

  • A home supply of prednisone for use in worsening asthma, as part of a current asthma plan

  • Self-reported diagnosis of chronic obstructive pulmonary disease, bronchiectasis or interstitial lung disease

  • Self-reported greater than 20 pack year smoking history, or onset of respiratory symptoms after the age of 40 years in current or ex-smokers with ≥10 pack year history

  • Self-reported current pregnancy or breast feeding at the time of enrolment or planned pregnancy within the study period

  • Unwilling or unable to switch from current asthma treatment regimen

  • Other illness(es) likely to compromise participant safety or impact on the feasibility of results, at the discretion of the investigator (examples include unstable coronary disease and malignancy)

*Assessment of participant adherence is by patient self-report of inhaler use in the past month at the time of study enrolment.

ICS, inhaled corticosteroid; GINA, Global INitiative for Asthma; LABA, long-acting beta agonist; SABA, short-acting beta agonist.