Improved Asthma Control After Changing From Low-to-Medium Doses of Other Inhaled Corticosteroids to Low-Dose Fluticasone Propionate

Stuart W. Stoloff, MD, Sharon H. Srebro, MD, Lisa D. Edwards, PhD, Marty C. Johnson, MS, Kathleen A. Rickard, MD

Disclosures
In This Article

Results

During the double-blind portion of the studies, a total of 1181 patients changed from low-to-medium doses of other inhaled corticosteroids to low-dose fluticasone propionate (176 or 200 mcg daily) and were categorized as the low-dose fluticasone propionate group for this analysis. In 3 of the 11 adult studies comprising this database, 272 patients were randomized to receive low-dose beclomethasone dipropionate (336 mcg daily), and were categorized as the low-dose beclomethasone dipropionate or control group. Demographics and baseline pulmonary function were similar across both groups except for significantly higher asthma symptom scores (P = .045) in the beclomethasone dipropionate group (Table 2). The percentage of patients who withdrew from the studies for any reason was higher in the beclomethasone dipropionate group (36%) than in the fluticasone propionate group (18%). Of these, a higher percentage of patients withdrew due to lack of efficacy (24%) in the beclomethasone dipropionate group than in the fluticasone propionate group (10%).

Baseline percent of predicted FEV1 was used to indicate the level of asthma severity (mild: >= 80%; "mild"-to-moderate: >= 70% to < 80%; moderate: >= 60% to < 70%; and severe: < 60%). Baseline demographics and pulmonary function in these 4 categories of patients were generally similar, except that asthma symptom scores tended to be higher and percent symptom-free days tended to be lower in the beclomethasone dipropionate group (Table 3). Baseline demographics and pulmonary function were similar among patients grouped according to prior inhaled corticosteroid therapy, namely, beclomethasone dipropionate (all doses), flunisolide, and triamcinolone acetonide (Table 4).

Low-dose fluticasone propionate vs low-dose beclomethasone dipropionate. Percent change from baseline to end point in FEV1, morning and evening PEF, albuterol use, asthma symptoms score, and symptom-free days in all patients who changed to low-dose fluticasone propionate vs those who remained on low-dose beclomethasone dipropionate is presented in Figure 1. All efficacy parameters showed a greater improvement in the low-dose fluticasone propionate group when compared with those in the low-dose beclomethasone dipropionate group. Improvements in FEV1 and morning and evening PEF were approximately 1.5-fold to 4-fold greater in the low-dose fluticasone propionate group compared with the low-dose beclomethasone dipropionate group. The decrease in rescue albuterol use was about 4-fold greater, while improvements in asthma symptoms score and percent symptom-free days were approximately 2-fold greater in the low-dose fluticasone propionate group compared with patients on low-dose beclomethasone dipropionate.

Percent change ± SE from baseline to end point in FEV1, morning and evening PEF, asthma symptoms score, albuterol use (percent mean change), and % symptom-free days (mean change) in patients changed to low-dose FP from all other inhaled corticosteroids compared with those randomized to low-dose BDP. FP = fluticasone propionate; BDP = beclomethasone dipropionate; BID = twice daily.

Changes in efficacy parameters in the low-dose fluticasone propionate group. A majority of patients who changed from low-to-medium doses of other inhaled corticosteroids to low-dose fluticasone propionate either maintained (± 5% change) or showed improvements (> 5% increase) in efficacy parameters. Despite switching to a much lower dose of fluticasone propionate, approximately 40% to 60% of patients showed improvements in FEV1, morning and evening PEF, albuterol use, symptom scores, and symptom-free days, while approximately 14% to 48% maintained lung function and asthma control (Figure 2).

Percentage of patients who maintained (± 5% change), or showed improvements (>= 5% increase) in efficacy parameters in the low-dose fluticasone propionate group.

Prior inhaled corticosteroid therapy. Percent change from baseline to end point in FEV1, morning and evening PEF, albuterol use, asthma symptoms score, and symptom-free days improved significantly (P < .001) in patients who changed to low-dose fluticasone propionate from beclomethasone dipropionate (all doses) or triamcinolone acetonide. The magnitude of these improvements was independent of the type of prior inhaled corticosteroid treatment (Table 5). Improvements in these parameters were also seen in patients previously treated with flunisolide; however, data are not presented because of the small number of patients receiving this therapy (n = 36).

Degree of asthma severity. Improvements in FEV1, morning and evening PEF, albuterol use, asthma symptoms score, and symptom-free days over baseline were significantly greater (P <= .002 for all parameters) in the low-dose fluticasone propionate group and were independent of baseline asthma severity. Similar groups treated with low-dose beclomethasone dipropionate showed few significant improvements (Table 6). Except for a few variations, the magnitude of these improvements generally ranged from approximately 1- to 4-fold across patients with all categories of asthma severity. Patients with mild asthma severity who changed to low-dose fluticasone propionate showed significantly greater improvements in asthma symptom scores compared with a similar group of patients who remained on low-dose beclomethasone dipropionate.

Baseline demographics and lung function, as well as percent change from baseline in FEV1, morning and evening PEF, albuterol use, asthma symptoms score, and symptom-free days in pediatric patients treated with fluticasone propionate 100 mcg daily are shown in Table 7. Although there was no active comparator control group as in the case of adults, pediatric patients previously treated with beclomethasone dipropionate, flunisolide, or triamcinolone acetonide showed significant improvements in all efficacy parameters (P <= .002) compared with baseline values after treatment with fluticasone propionate 100 mcg daily.

The incidence of drug-related adverse events in adult patients who changed to low-dose fluticasone propionate was comparable (12.4%) to that of patients who remained on low-dose beclomethasone dipropionate (14.7%). A similar incidence of the most common drug-related adverse events, namely, candidiasis (2.5% vs 4.4%), hoarseness/dysphonia (2.6% vs 2.2%), throat irritation/sore throat/pharyngitis (2.2% vs 2.6%), headache (2.5% vs 4.0%), and cough (0.6% vs 0.7%) was observed in fluticasone propionate vs beclomethasone propionate patients, respectively. The overall incidence of drug-related adverse events was low (5%) in pediatric patients, with low incidences of candidiasis (1.2%), hoarseness/dysphonia (0.6%), throat irritation/sore throat/pharyngitis (1.9%), headache (0%), and cough (0.6%).

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