Table 2 The summary of clinical trials supporting the recommendation for symptom-driven (as-needed) ICS-formoterol strategy

Trial Design

Double-blind, multisite, parallel-group RCT

(Phase 3 trial)

Double-blind, multisite, parallel-group RCT

(Phase 3 trial)

Trial Duration

52 weeks

52 weeks

Patient population

1. Inclusion criteria: > 12 years or older, diagnosed with mild asthma at least 6 months previous to trial and deemed as needing Step 2 treatment

2. Average age of included patients: 39.6 ± 16.6 years.

1. Inclusion criteria: > 12 years or older, diagnosed with mild asthma at least 6 months previous to trial and deemed as needing Step 2 treatment

2. Average age of included patients: 41.0 ± 17.0 years

Total number of patients

3849

4215

Treatment arms

1. Twice-daily placebo + as-needed terbutaline (0.5 mg).

2. Twice-daily placebo + as-needed budesonide-formoterol (200/6 μg).

3. Twice-daily budesonide (200 μg) + as-needed terbutaline (0.5 mg).

1. Twice-daily placebo + as-needed budesonide-formoterol (200/6 μg).

2. Twice-daily budesonide (200 μg) + as-needed terbutaline (0.5 mg).

Primary outcome

Weeks with well-controlled asthma.

Annualised rate of severe exacerbations

Conclusion

As-needed inhaled budesonide-formoterol provided superior asthma-symptom control to as-needed terbutaline but was inferior to budesonide maintenance therapy. Exacerbation rates with the two budesonide-containing regimens were similar and lower than in the terbutaline only group. Budesonide-formoterol used as-needed, resulted in substantially lower glucocorticoid exposure.

As-needed use of inhaled budesonide-formoterol was non-inferior to budesonide maintenance therapy concerning the annualised rate of severe asthma exacerbations but was inferior in controlling symptoms. Budesonide-formoterol used as-needed, resulted in substantially lower glucocorticoid exposure.