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

Table of Content


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.


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.


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.


Primary Endpoint

  • Improvement in FEV1 at the end of 12 weeks

Secondary Endpoints

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


  • 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


  • 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