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Combination Therapy More Effective Than Single Therapy in Mild to Moderate Asthma: Presented at AAAAI

By Maggie Schwarz

WASHINGTON, DC -- March 17, 2009 -- Combination fluticasone propionate/formoterol fumarate (FP/FM) inhaler is more effective and improves lung function better than each agent alone in adolescents and adults with mild to moderate asthma, researchers reported here at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

Anthony D. D'Urzo, MD, Primary Care Lung Clinic, Toronto, Ontario, and colleagues compared the efficacy of FP/FM 100/10 mcg combination therapy against monotherapy with FP 100 mcg, FM 10 mcg, or placebo in adolescent and adult patients with mild to moderate asthma. They reported the results on March 15.

Current guidelines recommend use of inhaled corticosteroids (ICS) as first-line therapy for control of persistent asthma, Dr. D'Urzo explained. Combination therapy using a single-inhaler to administer an ICS for airway inflammation and a long-acting beta₂ agonist for bronchodilation achieves superior long-term asthma management. However, a significant portion of asthmatics remain poorly controlled, he said.

A novel fixed-dose combination of FP and FM delivered simultaneously via a hydrofluoroalkane (HFA 227) pressurised metered-dose inhaler (pMDI) is under investigation for long-term maintenance treatment of persistent asthma in patients 12 years of age and older.

Dr. D'Urzo and his group performed a 12-week, randomised, double-blind, placebo-controlled, parallel-group, stratified, multicentre study.

Treatments were FP/FM HFA pMDI 50/5 mcg BID, either drug alone BID administered by HFA pMDI, or placebo. During a run-in period, patients requiring steroid therapy received FP 50 mcg BID as maintenance therapy.

The 459 patients assessed were aged a mean of 38.8 years, had a duration of asthma of 20.30 years, and a forced expiratory volume in 1 second (FEV₁) of 2.41 L, FEV₁ percentage predicted of 73.0%, and reversibility of 22.63%. Mean change in predose FEV₁ from baseline to week 12 was significantly greater for FP/FM 100/10 mcg than FM 10 mcg (0.195 L vs 0.094 L, P = .045).

Mean change in predose FEV₁ from baseline to 2 hours postdose at week 12 was significantly greater for FP/FM 100/10 mcg than FP 100 mcg (0.392 L vs 0.191 L, P < .001).

Reports of adverse events were low and similar across all treatment groups.

Dr. D'Urzo and colleagues concluded that twice-daily combination FP/FM was more effective than monotherapy with either drug alone in patients with mild to moderate asthma.

Funding for this study was provided by SkyePharma and Abbott Respiratory LLC.

[Presentation title: Efficacy of Twice Daily Fluticasone Propionate and Formoterol Fumarate Combination Administered Using an HFA pMDI in Patients With Mild to Moderate Asthma. Abstract 292]

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