Consistent Targeted Dosing of BUD Benefits Asthma Patients Needing Long-Term Oral Corticosteroids

Mary Beth Nierengarten

doi:10.1177/155989771411010

Summary

In patients with severe asthma who depend on long-term oral corticosteroid therapy, additional treatment with consistent doses of budesonide (BUD) delivered by a novel inhalation system significantly improved lung function and control of asthma exacerbations. This article discusses outcomes from the AKITA Inhaled Steroid Suspension for Inhalation in Subjects With Asthma [AICS; NCT01200108; Canisius S et al. Am J Respir Crit Care 2014]

Pulmonary Clinical Trials
Asthma

Pulmonary Clinical Trials
Pulmonary & Critical Care
Asthma

Sebastian Canisius, MD, Vectura GmbH, Frankfurt, Germany, reported outcomes from the AKITA Inhaled Steroid Suspension for Inhalation in Subjects With Asthma [AICS; NCT01200108; Canisius S et al. Am J Respir Crit Care 2014]—a Phase 2/3, randomized, placebo-controlled trial featuring 4 arms and parallel groups. In it, researchers evaluated the efficacy of a novel computer-controlled, compressor-driven inhalation system (Akita; Activaero) that delivered consistent doses of BUD as add-on treatment in patients with severe asthma on long-term oral corticosteroids therapy.

In the study, adult patients (age, 18 to 65 years; Table 1) from 27 respiratory outpatient centers in Germany, Poland, and Ukraine were randomly assigned in a double-blind fashion to 1 of 4 treatment arms for 18 weeks:

AICS-BUD (1 mg): AKITA-inhaled corticosteroid+BUD (1 mg, twice a day [BID]; n=80)
AICS-BUD (0.5 mg): AKITA-inhaled corticosteroid+ BUD (0.5 mg, BID; n=39)
AICS-placebo: AKITA-inhaled corticosteroid+placebo (BID; n=40)
CN-BUD: open-label treatment with BUD (1 mg, BID) administered with a conventional nebulizer (n=40)

The doses of long-term corticosteroid therapy were tapered until Week 14, and patients were followed to Week 20.

View this table:

Table 1.

Baseline Characteristics^{^a}

Efficacy was assessed on the basis of lung function parameters, including mean forced expiratory volume in 1 second (FEV₁), as well as mean change in forced expiratory flow from 25% to 75% of vital capacity, which (FEF_25–75) that the authors noted is a fairly reliable surrogate marker of small airway function. These lung function parameters were recorded during each patient visit for 2 weeks.

Overall, the study revealed that the dose of long-term oral corticosteroids was reduced in all treatment arms. For patients who received add-on therapy, lung function parameters improved significantly at Week 18 from baseline, whereas no significant improvements were seen in patients in the placebo and conventional nebulizer arms. The mean FEV₁ were 239 mL (p<0.001) and 126 mL (p=0.01) for AICS-BUD (1 mg) and AICS-BUD (0.5 mg), respectively, and 93 mL (p=0.36) and 137 mL (p=0.18) for placebo and CN-BUD, respectively. Regarding small airway function, the study revealed that patients treated with AICS-BUD (1 mg) had significant improvement in mean FEF_25–75 from baseline to Week 18 compared with patients in the AICS-placebo arm. The study also indicated that patients treated with AICS-BUD (1 mg), compared with those treated by CN-BUD, had fewer asthma exacerbations (7.5% vs 22.5%), a longer mean time to first exacerbation (96.5 vs 50.1 days), and a smaller subsample of patients who experienced asthma instability (15.0% vs 25.0%).

These findings show an improvement in lung function 12 weeks after initiation of consistent dosing of BUD via a novel delivery system. Without controlling for differences among treatment groups, there appears to be greater benefit of consistent delivery of BUD (1 mg) over similar dosing with a conventional nebulizer.

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