The Salmeterol or Corticosteroids (SOCS) and the
Salmeterol with and without Inhaled Corticosteriods (SLIC) Trials
Objectives:
These two randomized, placebo-controlled, blinded
clinical trials were concurrently managed to determine whether Inhaled
Corticosteriod (ICS) therapy can be reduced or eliminated in patients with
persistent asthma after adding a long-acting Beta 2-agonist to their treatment
regimen.
Background:
Treatment guidelines recommend the addition of
long-acting Beta 2-agonists for patients with persistent asthma that is
inadequately controlled through mild to moderate doses of inhaled
corticosteroids (ICSs). No evidence exists, however, to support their use as
monotherapy in adults with persistent asthma. The SOCS trial was initiated to
determine the efficacy of salmeterol therapy as a replacement for ICS therapy.
The SLIC trial sought to determine if the addition of a long acting beta
2-agonist permitted a reduction in dose, and/or elimination of, inhaled
corticosteroids over time.
Subjects:
Patients were randomized to either the SOCS or SLIC
trial at 6 Asthma Clinical Research Network sites after a 6 week run-in period
in which patients were treated with inhaled triamcinolone acetonide (400
µg twice per day). Patients whose asthma was well-controlled at 4 weeks
into the run-in period were randomized into the SOCS trial while patients whose
asthma was not well-controlled were randomized into the SLIC trial. In the SOCS
Study, one hundred sixty-four patients aged 12 through 65 years were randomized
into one of three arms: 1) triamcinolone therapy, 2) salmeterol xinafoate, or
3) placebo. In the SLIC study, one hundred seventy-five patients aged 12
through 65 years initially continued the triamcinolone therapy. During a
two-week salmeterol induction phase, 13 of every 15 patients received
slameterol add-on therapy and two of every thirteen patients received placebo.
After two weeks, half of patients assigned to salmeterol add-on therapy were
randomly assigned to either maintain triamcinolone therapy or undergo a
blinded, 1-step reduction in triamcinolone for the first 8 weeks followed by
triamcinolone elimination.
Conclusions:
The results indicate that in patients with persistent
asthma suboptimally controlled by triamcinolone therapy alone but whose asthma
symptoms improve after addition of salmeterol, a substantial reduction (50%) in
triamcinolone dose can occur without a significant loss of asthma control.
However, total elimination of triamcinolone therapy results in a significant
deterioration in asthma control and, therefore, cannot be recommended. (JAMA,
2001;285:2583-2593. JAMA, 2001;285:2594-2603.)
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Study Website |
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Study Documentation |
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Data Distribution Agreement |
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