Deterioration in Asthma Control When Subjects Receiving Fluticasone Propionate/Salmeterol 100/50 mcg Diskus are “Stepped-Down”

Abstract

In this study, 647 subjects stable on fluticasone propionate/salmeterol Diskus 100/50 mcg BID (FSC) were randomized to continue FSC 100/50 mcg BID or "step down" to either fluticasone propionate (FP) 100 mcg BID, salmeterol (SAL) 50 mcg BID, or montelukast (MON) 10 mg once daily for 16 weeks. Overall asthma control significantly improved in the FSC group; whereas, "stepping down" to FP, SAL, or MON resulted in deterioration in asthma control, as determined by decreased measures of lung function and clinical features. This study provides support that treatment of both inflammation and smooth muscle dysfunction may be necessary to achieve and maintain asthma control in patients uncontrolled on ICS.

Stepping down from combination asthma therapy: The predictors of outcome

“…One reason for this discrepancy may be that in the present study the asthma control before discontinuing LABAs may have been better and more long-lasting than in the previous studies [5]. On the other hand, the main outcome measure in the previous studies has usually not been exacerbation frequency but symptom severity [21,22], PEF values [21e23], rescue medication use [22,23], or minimal ICS dose to maintain asthma control [3]. In fact, the risk of exacerbations or other serious events after LABA cessation could not be evaluated in the meta-analysis of these studies because of the small number of events [5].…”

The US Food and Drug Administration and long-acting β2-agonists: The importance of striking the right balance between risks and benefits of therapy?

“…Indeed, 3 separate studies found that stepping off LABAs after the establishment of acceptable asthma control resulted in the patient's asthma becoming less well controlled. [9][10][11] Although confirmatory studies are needed, these initial results do not support the FDA's proposed recommendation that the step down be withdrawal of LABAs.…”

Asthma diagnosis and treatment: Filling in the information gaps

“…37,38 Three separate studies have shown that stepping off of LABAs when asthma control appears stable, however, has resulted in a loss of asthma control. [45][46][47] Addressing when and what treatment to reduce during a step down is more complex. In the Gaining Optimal Asthma Control study, Bateman et al 48 reported that treatment escalation with either ICSs or ICSs plus LABAs led to greater levels of asthma control in many but not all enrolled subjects and was achieved by using a step up in therapy.…”