COPD: Discontinuing Inhaled Corticosteroids Does Not Increase Exacerbations

With the right maintenance treatment, patients with severe and very severe chronic obstructive pulmonary disease (COPD) can safely be weaned off inhaled corticosteroids (ICS).

The WISDOM (Withdrawal of Inhaled Steroids During Optimised bronchodilator Management) study set out to observe changes in trough FEV (forced expiratory volume) after the discontinuation of ICS. Donald P. Tashkin, MD, from the Department of Medicine at the University of California, Los Angeles, unveiled the results during a poster session at the 2015 American College of Allergy, Asthma, and Immunology Annual Scientific Meeting (ACAAI 2015) in San Antonio, Texas.

The analysis included 2,485 patients with severe to very severe COPD. Patients were excluded from the study if they had a respiratory tract infection or had a COPD exacerbation within six months of starting the trial. The average age in each group hovered around 64 years and there were similar characteristics when it came to gender, duration of COPD diagnosis, smoking history, and baseline lung function. They were randomly assigned to either continue ICS or withdraw. Before this, however, all participants received tiotropium (18 µg once daily) (QD), salmeterol (50 µg twice daily (BID) — two actuations of 25 µg), and fluticasone propionate (500 µg BID – two actuations of 250 µg) by metered-dose inhaler for six weeks before the study.

Those in the ICS-continuation group continued this regimen. However, the ICS-withdrawal group only continued taking the tiotropium and salmeterol and went through a stepwise reduction of fluticasone propionate dose every six weeks, and at week 12 the dose became a placebo.

After 52 weeks, the researchers analyzed the difference in trough FEV from baseline to one year. The results were separated by change:

• 598 Patients: Decrease (Ë‚ -130 mL)
• 673 Patients: Intermediate change (˃ -130 mL to Ë‚ 20 mL)
• 634 Patients: Increase (˃ 20 mL)

The rate of exacerbations were similar within each FEV change group no matter if the patients continued or discontinued ICS. This indicates that there is no relationship between exacerbation rates and FEV changes — whether it increased, decreased, or remained relatively the same.

“There was a small but statistically significant reduction in trough [FEV] in one second, following complete withdrawal of ICS compared to ICS continuation,” the results said.

So while it seems that the treatment did not increase risk, there didn’t prove to be much benefit to it either.

Still, the authors will press on, “The changes in lung function observed in the WISDOM study warrant further investigation, particularly to determine if there is a link between the magnitude of change in trough FEV, and the incidence and rate of exacerbations.”