STAY Study

29 Nov, 12

Stay Study

Introduction

First study to report about SMART i.e. budesonide/formoterol (Bud/Form) as Single Maintenance and Reliever Therapy.

Approach

Low dose regular ICS + LABA for maintenance and relief, thus introducing steroid in immediate phase of asthma worsening.

Methods

Double-blinded, randomized parallel-group 1 year study
Patients
N=2,760 patients with asthma aged 4-80 yrs.
FEV₁ 60- 100% predicted
Adults - 400- 1,000 mcg/day ICS
Children - 200-500 mcg/day ICS
246 centres in 22 countries
Patients attended the clinic at the beginning and end of the run-in and after 1,3,6,9 and 12 months of treatment
2760 patients were randomised to three different treatment groups-
1. Bud (400 mcg bid) + SABA (N= 926)
2. Bud/Form (100/6 mcg bid) + SABA ( N = 909)
3. Bud/Form (100/6 mcg bid) SMART (N=925)

SABA - Terbutaline 0.4 mg as needed.

Adults could use a maximum of 10 and children 7 as-needed inhalations per day before contacting investigator.

Outcome Variables

Primary Efficacy Variable-
Time to first severe exacerbation

Exacerbations - a very good indication of the underlying inflammation in asthma.

Time to First Exacerbation

Bud/Form as SMART significantly prolonged the time to first severe exacerbation when compared with bud/form + SABA and bud + SABA

Risk of Exacerbations

The risk of severe asthma exacerbation was 45% lower with Bud/Form as SMART versus Bud/Form + SABA and 47% lower than a fourfold higher dose of bud + SABA

Morning PEFR

Bud/Form as SMART significantly improved morning PEF compared with Bud/Form + SABA and a 4-fold higher maintenance dose of Bud + SABA

Total Exacerbations

Rate of total exacerbations reduced by 47% in Bud/Form SMART

Improved nighttime symptoms and awakenings (p<0.05)
Mean reliever use was lower
All treatments were well tolerated

Conclusion

Bud/Form SMART vs. traditional fixed dosing regimens:
- Reduces the risk and rate of severe asthma exacerbations and the need for systemic steroids
- Improves asthma symptoms, nocturnal awakenings, and lung function
- Reduces the morbidity and potentially the mortality of asthma

Clinical Implications

Formoterol provided rapid symptom relief: no separate reliever was required
Bud/Form SMART can be used:
- to reduce the incidence of first and repeated severe exacerbations instead of high maintenance dose of budesonide
- In patients who do not adhere fully to ICS and instead overrely on SABAs as reliever medication

Am J Respir Crit Care Med 2005; 171:129-136