Forty–six asthmatic patients (males: 20, females: 26; mean age 35 years) with reversible asthma (FEV1≥65%; ≥12% reversibility), airway hyperreactivity (methacholine PC20≤5 mg/ml), and clinical symptoms (bronchodilator use ≥4 days/week) entered this study designed to examine the effects of a primary anti–inflammatory agent (triamcinolone acetonide) compared to a long–acting maintenance bronchodilator (salmeterol), to the combination of both therapeutic agents, and placebo with respect to improvement in clinical symptoms, pulmonary function, and bronchoprotective properties.After initial screening and a 2–week observational period, eligible patients were enrolled into the 6–month treatment arm of the study. Patients were randomized to treatment with either (1) triamcinolone at a dose of 2 puffs four times a day (800 µg/day)×4 weeks followed by a maintenance dosage of 4 puffs twice a day (800 µg/day), (2) salmeterol at 2 puffs twice a day (84 µg/day) and (3) the combination of triamcinolone plus salmeterol twice daily, or placebo. During this treatment phase, methacholine challenge was performed at (2–month) intervals and formal spirometry was done at monthly intervals. Patients continued to keep symptom diaries, medication diaries, and performed peak flow measurements through the 6–month treatment period.Triamcinolone progressively reduced methacholine sensitivity at each time point studied over the 6–month period of treatment. Salmeterol did not result in a significant shift in bronchial hyperresponsiveness. In the group of patients receiving combination therapy, the bronchoprotective effects of triamcinolone were maintained over the 6–month study period (see table 1).Each active treatment resulted in a positive effect on pulmonary function (FEV1). Triamcinolone resulted in a significant increase in FEV1 over baseline at 3 months and 5 months of treatment. Salmeterol also demonstrated a positive effect on FEV1 at 3 months and 5 months of treatment. The combination (triamcinolone plus salmeterol) resulted in an even earlier improvement in FEV1 which was evidenced at 1 month of treatment (p = 0.01) and was sustained at 3 and 5 months of therapy. As expected, placebo treatment did not result in a beneficial effect on FEV1 at any time point. Furthermore, significant between–group differences were observed for both triamcinolone (p = 0.05) and for the combination (triamcinolone plus salmeterol; p = 0.007) when compared with placebo. These findings were corroborated by clinical parameters which demonstrated that all active treatment groups resulted in marked improvement in symptom control (a.m./p.m. symtpoms) and the reduction in the frequency of bronchodilator use. Fewer noctural awakenings were observed in the salmeterol and the combination treatment groups when compared to baseline (table 2).In summary, inhaled steroid treatment (triacinolone acetonide) demonstrated a significant reduction in bronchial hyperresponsiveness (improvement of methacholine PD20 from baseline), a significant effect on parameters of pulmonary function (FEV1 and PEF), and improvement in clinical symptoms. Salmeterol did demonstrate significant improvement in lung function and symptom control. However, salmeterol was not as effective as either triamcinolor or combination therapy in terms of reducing bronchial hyperresponsiveness. An added benefit observed from combining an inhaled steroid with a long–acting bronchodilator was an earlier shift in FEV1 response.
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Creticos et al. (1999) studied this question.