GOAL (Gaining Optimal Asthma Control) Study

GOAL - A Landmark Study

To study whether patients with asthma can achieve control as defined by the guidelines
Compared the efficacy and safety of stepwise increases of salmeterol/fluticasone with fluticasone in achieving 2 predefined composite measures of asthma control

Current medication (ICS) for 4 week run in period assessed at each week
Patients who did not achieve 2 well controlled weeks in the 4 week run-in period were randomized to one of 3 stratas based on their ICS dose

These patients were then randomized and stratified according to baseline treatment in previous 6 months.

Stratum 1. Corticosteroid na?ve or 'corticosteroid-free'

Stratum 2. <500 mcg BDP daily or equivalent

Stratum 3. >500 - <1000 mcg BDP or equivalent

Stratified, randomized, double-blind, parallel-group study

Patients achieving TC at any time during Phase I were placed into Phase II & continued with the same dose

Difference represents an additional 85-95 symptom-free days per year with SFC in patients previously symptomatic on ICS

* measured as weeks during which patients are uncontrolled

At end of 1 year, 41% patients achieved Total control and 71% patients were Well controlled
More patients achieve total control with SFC than ICS alone regardless of previous treatment
Significantly more patients achieve guideline based asthma control with SFC vs FP, regardless of previous treatment
SFC might be considered the preferred treatment for all patients with uncontrolled asthma
Patients achieving asthma control, maintain a similar level of control with regular, stable dosing, with little likelihood of losing control

1. Am J Respir Crit Care Med 2004; 170: 836-844
2. Prim Care Respir J 2007;16:155-161
3. Allergy 2008; 63: 932-8

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