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Table 4 Symptom-based therapy adjustment (all therapeutic adjustments will be automatically calculated and advised by the e-CRF)

From: A randomised pragmatic trial of corticosteroid optimization in severe asthma using a composite biomarker algorithm to adjust corticosteroid dose versus standard care: study protocol for a randomised trial

Asthma Control (ACQ7)

Treatment increased according to Table 5

ACQ7 ≥ 1.5 and ≥ 1 change from baseline score

OR

severe exacerbation since last visit (past 8 weeks at baseline randomisation visit)

Increase therapy 1 step

ACQ7 is 1.0 to < 1.5 OR ACQ ≥ 1.5 and < 1 change from baseline score AND

no severe exacerbation since last study visit (past 8 weeks at baseline randomisation visit)

No change

ACQ7 < 1.0

AND

no severe exacerbation since last study visit (prior 8 weeks at baseline randomisation visit)

Reduce therapy 1 step

  1. All therapeutic adjustments will be automatically calculated and advised by the electronic case report form (e-CRF)
  2. ACQ7 7-item Asthma Control Questionnaire