FACET (Formoterol and Corticosteroids Establishing Therapy) Study: A Landmark Study in Asthma Therapy

2 Jan, 13

Aim

To evaluate the effects of adding inhaled formoterol to both lower and higher doses of the inhaled glucocorticoid budesonide.

Hypothesis - By addition of LABA to ICS, the risk of exacerbations will increase.

Study Methods

Double-blind, randomized, placebo-controlled, parallel-group, multicentre trial
852 asthma patients aged 18 to 70 years using inhaled corticosteroid with FEV₁ >= 50% of predicted, >= 15% reversibility
4 week run-in period during which patients received 800 mcg budesonide b.i.d.

Study Design

Primary Efficacy Variable

The primary efficacy variables studied were the rates of severe and mild exacerbations of asthma per patient per year.

Other variables like
- PEF,
- symptoms (score),
- awakening due to asthma
- use of oral glucocorticoids were also recorded.

Results

Rate of severe exacerbation

Rate was reduced by 26% in low dose BUD and FORM group and by 63% in high dose BUD and FORM

Rate of mild exacerbation

Rate of mild exacerbations reduced by 40% when FORM was added to lower dose of BUD

Symptoms - Significant improvement in both day and night time symptom scores in combination groups.
Lung Function - Higher dose BUD/FORM > lower dose BUD/FORM > high dose BUD > low dose BUD
All the treatment strategies were well tolerated.

Conclusion

There was no evidence of deterioration in the control of asthma over the course of one year when formoterol was added to budesonide therapy.
BUD/FORM decreases the incidence and rates of mild and severe exacerbations.
BUD/FORM also improved asthma symptom scores and lung function and reduced the need for rescue medication.

N Engl J Med 1997; 337: 1405-11

Related Topics

corticosteroids