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Title: Mometasone Equivalent to Fluticasone in Patients with Moderate to Severe Persistent Asthma: Presented at ACAAI

"Mometasone Equivalent to Fluticasone in Patients with Moderate to Severe Persistent Asthma: Presented at ACAAI"

By Corinna S. Bowser, MD PHILADELPHIA, PA -- November 15, 2006 -- In patients with moderate to severe persistent asthma, mometasone furoate dry powder inhaler (MF-DPI, Asmanex Twisthaler) has efficacy equivalent to that of fluticasone propionate dry powder inhaler (FP-DPI, Flovent), according to study results presented here at the 2006 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI). Besides confirming the efficacy of the mometasone treatment, the study may reflect a renewed interest in single-agent approaches to controlling asthma, as opposed to the combination of an inhaled corticosteroid and a long-acting beta agonist (LABA) bronchodilator, said researcher Gordon Sussman, MD, professor of medicine, University of Toronto, Toronto, Ontario, Canada. "This shows the therapeutic effectiveness in patients with moderate to severe asthma was the same with mometasone and fluticasone," Dr. Sussman said during a presentation on November 12[^th. "The difference [between this and earlier studies] is, this is basically controlling asthma with the steroid, but without the [need of an additional] bronchodilator."

The open-label, randomized study included participation of 24 centers in Europe and Canada. Subjects were at least 18 years of age and required an inhaled corticosteroid for asthma control. All were stable on a previous regimen of inhaled corticosteroid.

Patients enrolled in the study first had their dose of corticosteroid reduced until they developed mild asthma symptoms. They were then randomized to mometasone 400 mg twice daily or fluticasone 500 mg twice daily for a total of 12 weeks.

For the 202 patients in the intent-to-treat population, there was no difference between the mometasone and fluticasone groups in the primary endpoint of baseline morning peak expiratory flow rate (PEFR) -- 361 and 352 L/min, respectively (P = .532). Likewise, there were no significant differences between groups in evening PEFR, forced expiratory volume in 1 second, use of salbutamol, therapeutic response, or exacerbation of asthma. The 2 treatment groups had similar morning and evening asthma symptoms.

In both groups, the most common adverse events were headache, influenza-like symptoms, and dyspnea, and there were no significant differences between groups in incidence of these symptoms.

Statistical analysis confirmed that mometasone was noninferior to fluticasone, as the 95% confidence interval for the difference in morning PEFR between treatments was within +/-10%.

This study was supported by Schering-Plough.

[Presentation title: Comparative Trial of Mometasone Furoate Versus Fluticasone Propionate in Patients With Moderate to Severe Persistent Asthma. Abstract P92]

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