Jane S. Ricciuti, RPh, MS


July 13, 2004

In This Article

Respiratory Agents

Flovent HFA
(fluticasone propionate HFA)

Manufacturer: GlaxoSmithKline

Drug Approval Classification: Original New Drug Application (Approval Date: 5/14/04)

Indication: Flovent HFA (fluticasone propionate HFA) inhalation aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adolescent and adult patients 12 years of age and older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be able to reduce or eliminate their requirement for oral corticosteroids over time.

Flovent HFA is NOT indicated for the relief of acute bronchospasm.

Dosing: The recommended starting dosage and the highest recommended dosage of Flovent HFA is based on prior asthma therapy; please refer to product labeling for additional details.

Clinical Summary: Three randomized, double-blind, parallel-group, placebo-controlled clinical trials were conducted in 980 adolescent and adult patients (≥ 12 years of age) with asthma to assess the efficacy and safety of Flovent HFA in the treatment of asthma. Fixed dosages of 88, 220, and 440 mcg twice daily (each dose administered as 2 inhalations of the 44-, 110-, and 220-mcg strengths, respectively) and 880 mcg twice daily (administered as 4 inhalations of the 220-mcg strength) were compared with placebo to provide information about appropriate dosing to cover a range of asthma severity.

All 3 dosages of Flovent HFA significantly improved asthma control as measured by improvement in morning predose FEV1 compared with placebo. Pulmonary function (AM predose FEV1) improved significantly with Flovent HFA compared with placebo after the first week of treatment, and this improvement was maintained over the 12-week treatment period.

Adverse Effects: A significant number of adverse events involved the ear, nose, or throat, including upper respiratory tract infection (18%). The incidence of headache was 11%.


Flovent HFA (fluticasone propianoate HFA) Labeling


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