Background: Asthma treatment aims to reduce symptoms, exacerbations, and long-term complications by using the lowest dose possible to minimize adverse effects. Patients with mild persistent asthma (who comprise up to 70 percent of all persons with asthma) can be treated with low-dose inhaled corticosteroids, whereas those with moderate asthma often require an inhaled corticosteroid and a long-acting beta agonist. In patients with moderate to severe asthma, studies have shown more benefit with a low-dose inhaled corticosteroid combined with a long-acting beta agonist than with inhaled corticosteroids alone. In the few studies of patients with mild asthma, the results indicate that these treatment options have similar effectiveness. Postma and colleagues conducted a randomized controlled trial to evaluate the effectiveness of monotherapy with the inhaled corticosteroid ciclesonide (Omnaris) versus the combination inhaled corticosteroid and long-acting beta agonist fluticasone/salmeterol (Advair) in patients with mild asthma.
The Study: The authors randomized 657 patients with a clinical diagnosis of mild persistent asthma to three groups: placebo, ciclesonide in a dosage of 160 mcg daily, or fluticasone/salmeterol in a dosage of 100/50 mcg twice daily. Patients participated in a two-week run-in period and were allowed to use salmeterol (Serevent) as a rescue medication. Criteria for randomization to treatment after the run-in period included a predicted forced expiratory volume in one second of 80 percent or more, reversible airway obstruction, limited use of rescue salmeterol, no nighttime asthma symptoms, and a daytime symptom score of 3 through 9. Patients were excluded if they had ever smoked, had an asthma exacerbation within two months of the run-in period, were hypersensitive to inhaled corticosteroids, had chronic obstructive pulmonary disease, were thought to be noncompliant, were intolerant of short-acting beta agonists, or had started immunotherapy. The primary outcome was time to the first severe asthma exacerbation (defined as a more than 30 percent decrease in peak expiratory flow from baseline on two consecutive days, or the need for oral corticosteroids, hospitalization, or other emergency treatment). Patients also recorded daytime and nighttime asthma symptoms (scale 0 to 4: 0 = no symptoms; 4 = unable to carry out daily activities, or awake most of the night because of asthma symptoms).
Results: Only the fluticasone/salmeterol treatment increased the time to first exacerbation (P = .0002) and decreased the risk of having a first severe asthma exacerbation during the 12-month study (P = .0002). In addition, pulmonary function improvements were noted only in the fluticasone/salmeterol group (P < .0001). However, when compared with placebo, ciclesonide achieved levels of daily asthma control similar to those of fluticasone/salmeterol. This was measured by the median number of poorly controlled asthma days (1.5, 1.8, and 6.2 days per 12 months for ciclesonide, fluticasone/ salmeterol, and placebo, respectively); the median number of asthma symptom–free days (31, 23, and 17.5 days per 12 months for ciclesonide, fluticasone/ salmeterol, and placebo, respectively); asthma symptom scores (ciclesonide, P = .0015; fluticasone/salmeterol, P = .0007); and reduced rescue medication use (ciclesonide, P = .0001; fluticasone/salmeterol, P = .0005).
Conclusion: Although the combination treatment of fluticasone/salmeterol increased pulmonary function and time to first exacerbation, ciclesonide monotherapy was able to control symptoms of daily asthma in persons with mild persistent asthma. These results demonstrate that monotherapy with an inhaled corticosteroid may be considered as a first-line approach in patients who have mild persistent asthma and normal pulmonary function.