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Table 3 The summary of clinical trials supporting the recommendation for symptom-driven (as-needed) ICS with SABA strategy

From: It is time to change the way we manage mild asthma: an update in GINA 2019

Name of the trial

BEST (Beclomethasone plus Salbutamol Treatment) [33]

BASALT (Best Adjustment Strategy for Asthma in the Long Term) [35]

TREXA (Treating Children to Prevent Exacerbations of Asthma) [34]

Trial Design

Double-blind, double-dummy, randomised parallel group trial

Multiple blind, parallel, 3-group, randomised, placebo-controlled trial

Double-blind, four-treatment, placebo-controlled, randomised, parallel group trial

Trial Duration

6 months

9 months

44 weeks

Patient population

18–65 years and diagnosed with mild persistent asthma

> 18 years and diagnosed with mild to moderate persistent asthma well controlled with low-dose inhaled corticosteroids

6–18 years and diagnosed with mild persistent asthma.

Total number of patients

466

342

843

Treatment arms

1. Twice-daily placebo + as-needed beclometasone (250 μg) with salbutamol (100 μg) in a single inhaler.

2. Twice-daily placebo + as-needed salbutamol (100 μg).

3. Twice-daily beclometasone (250 μg) + as-needed salbutamol (100 μg).

4. Twice-daily beclometasone (250 μg) and salbutamol (100 μg) in a single inhaler + as-needed salbutamol (100 μg).

1. Beclometasone dose adjusted using physician assessment-based approach (PABA).

2. Beclometasone dose adjusted using biomarker-based (FeNO) approach (BBA).

3. Beclometasone dose adjusted based on symptoms (need for salbutamol), i.e. a symptom-based approach (SBA)

1. Twice-daily beclomethasone (40 μg) + as-needed beclometasone (40 μg) with salbutamol (90 μg).

2. Twice-daily beclomethasone (40 μg) + as-needed placebo with salbutamol (90 μg).

3. Twice-daily placebo + as-needed beclometasone (40 μg) with salbutamol (90 μg).

4. Twice-daily placebo + as-needed placebo with salbutamol (90 μg)

Primary outcome

Morning peak expiratory flow rate

Time to first treatment failure

Time to first exacerbation requiring a prednisone dose

Conclusion

Symptom-driven use of ICS with SABA in a single inhaler is as effective as ICS maintenance therapy and is associated with a lower cumulative dose of the ICS

Neither the SBA nor the BBA strategy for ICS therapy was superior to the standard PABA strategy for the outcome of treatment failure. Mean monthly inhaled beclometasone dose was lowest in the SBA group.

Daily ICS was the most effective treatment to prevent exacerbations. As-needed ICS with SABA was more effective at reducing exacerbations compared with SABA alone and had the lowest daily ICS dose. Rescue treatment with SABA alone should be avoided.

  1. ICS Inhaled corticosteroid, SABA Short-acting beta2 agonist