Higher Efficacy and Drug Adherence with Ciclesonide as Step-Down Therapy than Budesonide in Mild to Moderate Asthma

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Introduction

A step-down therapy after an initial treatment of 3 months has been recommended by the asthma management guidelines in patients with well controlled asthma. Discontinuing long-acting β2-agonist (LABA) therapy in adults and older children on combination of inhaled corticosteroids (ICS) and LABAs was associated with increased asthma-associated impairment, as per the findings of a recent meta-analysis. The US Food and Drug Administration recommend that LABA be discontinued once asthma is controlled by combination therapy and that treatment with ICS alone should be the long-term treatment for asthma control. Ciclesonide (CIC) is a new formulated ICS that could provide better control of asthma during LABA step-down therapy. This study evaluated the efficacy of step-down therapy from ICS and LABA combination to ICS only by using inhaled CIC alone in asthmatics.

Aim

This study compared the clinical benefit of CIC with budesonide (BUD) as step-down therapy. This is one of the first studies that compares a step-down therapy strategy between mono-ICSs from a combination therapy with ICSs and LABAs in patients with well controlled mild to moderate asthma.

Method

Study Design

Multicenter, open-label, randomized, parallel-controlled study

Treatment Strategy

  • The cohort comprised 150 patients with mild-to-moderate asthma well controlled by a combination of ICS and LABA for atleast 3 months
  • A total of 75 patients each received either CIC 320 μg once daily or 2 inhalations of BUD 200 μg twice daily for 12 weeks.

End-points

Primary Endpoint

  • Improvement in FEV1 at the end of 12 weeks

Secondary Endpoints

  • Asthma control test (ACT) scores
  • Maximum mid-expiratory flow (MMEF)

Results

  • The FEV1 remained stable throughout the 12-week CIC treatment.
  • In the BUD group, FEV1 significantly decreased at weeks 4 and 12 as shown in figure 1
  • The FEV1 (before bronchodilators) of the CIC group was significantly higher than that of the BUD group; p = 0.02 at 4 weeks at the end of 12 weeks; p=0.03 of step-down therapy.

Figure 1. FEV1 after 4 weeks, 8 weeks and 12 weeks of treatment in the BUD and CIC groups
  • The CIC group had a significantly higher MMEF than that of the BUD group (p = 0.02), especially after 4 and 8 weeks (p = 0.04) as shown in figure 2.

Figure 2. Mean change from baseline in MMEF after 4 weeks, 8 weeks and 12 weeks of treatment in the CIC and BUD groups.
  • The proportion of patients in the CIC group had significantly higher drug adherence as compared to BUD group (76.0% vs. 58.7%, p = 0.03)
  • CIC was ranked over BUD by both the patients and the physicians

Conclusion

  • The efficacy of ciclesonide (CIC) as a step-down therapy was significantly higher than budesonide (BUD) in patients well controlled on combination therapy
  • CIC had better drug adherence than BUD.

NPJ Prim Care Respir Med. 2014; 24: 14010. Doi: 10.1038/npjpcrm.2014.10

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