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Title: No Additional Benefit From Adding Montelukast to Fluticasone Propionate: Presented at ACAAI

"No Additional Benefit From Adding Montelukast to Fluticasone Propionate: Presented at ACAAI"

By Crystal Phend ANAHEIM, CA -- November 10, 2005 -- Adding montelukast (Singulair) to fluticasone propionate may not improve airway inflammation in patients with persistent asthma, according to a study presented here at the American College of Allergy, Asthma and Immunology (ACAAI). "Agents such as leukotriene modifiers are often used in conjunction with inhaled corticosteroids to treat aspects of the disease," said presenter John L. Stauffer, MD, senior director, Respiratory Medicine Development Center, GlaxoSmithKline, Research Triangle Park, North Carolina, during a presentation on November 6[^th. "However, very few studies have studied this directly."

Dr. Stauffer and colleagues conducted a double-blind study to look prospectively at overall clinical asthma control and airway inflammation.

The 103 adult patients with asthma inadequately controlled by beta2-antagonist therapy alone were randomized to receive fluticasone propionate alone 100 mcg twice daily or in combination with oral montelukast 10 mg once daily.

Patient demographics were similar between groups as was lung function as measured by forced expiratory volume (76% of expected for both groups).

Patients kept a diary of symptoms and spirometry was done at each visit. Bronchial biopsy and bronchial alveolar lavage (BAL) were done at baseline and at 12 weeks and were compared using matched pairs between groups.

Inflammatory cells and markers measured by BAL and bronchial biopsy -- including eosinophils, neutrophils, macrophages, and lymphocytes -- were similar between groups both in submucosa and epithelium.

Lung function and clinical parameters were not significantly different between groups either as measured by mean change from baseline in forced expiratory volume, morning peak flow, rescue albuterol use, and number of rescue medication-free days.

"There was no added improvement when montelukast was added to fluticasone propionate," Dr. Stauffer said.

He said this suggests that fluticasone propionate effectively treats leukotriene-mediated airway events in addition to broad control of inflammation, and not using a second drug may have some advantages if it does not provide added efficacy.

"Whenever you use 2 drugs instead of 1, you possibly add side effects," Dr. Stauffer said.

However, safety findings have not yet been released from the study, he said.

[Presentation title: Airway Inflammation Is Controlled in Asthma Patients With Fluticasone Propionate 100mcg Alone; Adding Montelukast 10mg Does Not Provide Additional Clinical Control or Add to the Control of Airway Inflammation. Abstract 5]

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