General Information

Dulera Inhalation Aerosal is a fixed-dose combination of the inhaled corticosteroid mometasone furoate plus the long-acting beta2-agonist formoterol fumarate dihydrate.

Dulera is specifically indicated for the treatment of asthma in patients 12 years of age and older.

Dulera is supplied as as an inhalation aerosal. The recommended starting dosages for Dulera treatment are based on prior asthma therapy.
Previous Therapy: Inhaled medium dose corticosteroids Recommended Dose: 100 mcg/5 mcg, 2 inhalations twice daily Maximum Recommended Daily Dose: 400 mcg/20 mcg
Previous Therapy: Inhaled high dose corticosteroids Recommended Dose: 200 mcg/5 mcg, 2 inhalations twice daily Maximum Recommended Daily Dose: 800 mcg/20 mcg

Clinical Results

FDA Approval
The FDA approval of Dulera was partially based on two randomized clinical trials (Trial 1, Trial 2). These trials enrolled a total of 1,509 patients 12 years of age and older with persistent asthma uncontrolled on medium or high dose inhaled corticosteroids. These studies included a 2 to 3-week run-in period with mometasone furoate to establish a certain level of asthma control. Trial 1 compared Dulera 100 mcg/5 mcg to its individual components, mometasone furoate 100 mcg and formoterol 5 mcg, and placebo). Trial 2 compared Dulera 200 mcg/5 mcg with Dulera 100 mcg/5 mcg and mometasone furoate 200 mcg. All medications were given as two inhalations twice daily by metered dose inhalers. In both trials Dulera resulted in significant improvement from baseline in lung function (mean area under the concentration-time curve for forced expiratory volume in 1 second, measured from 0 to 12 hours [FEV1 AUC0-12h]) at week 12, a primary efficacy endpoint, compared to mometasone furoate (Trial 1 and 2) and placebo (Trial 1). In Trial 1, these differences were maintained through week 26. The change in mean trough FEV1 from baseline to week 12 was assessed as another endpoint in both trials. In Trial 1, a significantly greater increase in the mean trough FEV1 was observed for Dulera 100 mcg/5 mcg compared to formoterol 5 mcg (the primary treatment comparison) as well as to placebo. In trial 2, a greater numerical increase in the mean trough FEV1 were was observed for Dulera 200 mcg/5 mcg compared to Dulera 100 mcg/5 mcg and mometasone furoate 200 mcg.

Side Effects

Adverse events associated with the use of Dulera may include, but are not limited to, the following:

• Nasopharyngitis
• Sinusitis
• Headache

Mechanism of Action

Dulera Inhalation Aerosal is a fixed-dose combination of the inhaled corticosteroid mometasone furoate plus the long-acting beta2-agonist formoterol fumarate dihydrate.

Additional Information

For additional information regarding Dulera or asthma, please visit the Dulera web page.