Experimental Treatments: Mometasone-Formoterol (Dulera)

Mometasone-formoterol (brand name Dulera by Merck) is used to treat asthma and improve lung function. An application has been submitted by Merck to regulatory authorities to treat COPD. Dulera is a combination of an inhaled corticosteroid (mometasone) with a long-acting bronchodilator (formoterol).

How does mometasone-formoterol work?

Mometasone is a corticosteroid that works by reducing swelling of the airways. Formoterol is a long-acting beta-agonist (LABA) that works by relaxing and opening the airways to the lungs, making breathing easier.

The anti-inflammatory activity of mometasone works upon the inflammatory lung processes, whose  agents include mast cells, eosinophils, neutrophils, macrophages and lymphocytes. However, the effects of corticosteroids in the treatment of COPD are less well-defined than they are in asthma treatment.

As a selective LABA, formoterol acts to stimulate an enzyme called adenyl cyclase in the smooth muscle cells of the lungs. This enzyme helps convert adenosine triphosphate (ATP) to cyclic adenosine monophosphate (cAMP). When the levels of cAMP increase, these muscle cells relax, inhibiting the release of mediators of immediate hypersensitivity from cells, especially mast cells.

Mometasone-formoterol studies in COPD

A completed Phase 3 study (NCT00383435) evaluated the effectiveness and safety of mometasone-formoterol (400/10 mcg) twice daily, mometasone-formoterol (200/10 mcg) twice daily, mometasone (400 mcg) alone twice daily, formoterol (10 mcg) alone twice daily, and a placebo over 26 weeks and included an additional 26-week safety extension.

The mometasone-formoterol (400/10 mcg) combination was shown to be an effective therapy for people with moderate to very severe COPD and both mometasone-formoterol dosages were well tolerated.

Another Phase 3 study (NCT00383721) was also completed in 2010 and with the same characteristics. It found the treatments with either mometasone-formoterol dosages improved lung function and respiratory health status, reduced number of flares (exacerbations) and were well tolerated in people with moderate to very severe COPD.

Based on these results, a change in the treatment of people with COPD from the Kaiser Permanente Mid-Atlantic States region was evaluated. People who were on a fluticasone-salmeterol treatment were changed to mometasone-formoterol. A total of 521 participants were included in the study, with the primary endpoint to determine the difference in the number of exacerbations six months before and after patients converted to mometasone-formoterol.

Secondary objectives included the number of intensive care unit admissions, hospitalizations, emergency department visits and clinic encounters due to COPD exacerbations, number of participants who required a change in the treatment, and any reasons for mometasone-formoterol discontinuation after conversion.

Although there were no statistically significant differences in the secondary objectives, there was a statistically significant decrease in the number of patients who had COPD exacerbations after converting to mometasone-formoterol treatment.


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