General Information

Qvar utilizes a hydrofluoroalkane (HFA) propellant for the delivery of a novel formulation of beclomethasone dipropionate. Beclomethasone dipropionate is a corticosteroid that produces anti-inflammatory activity. With Qvar, beclomethasone is delivered in smaller-sized particles that allow the medication to reach the small airways of the lung.

Qvar is specifically indicated for maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older.

For oral inhalation only. Starting dosage is based on prior asthma therapy and disease severity.

Treatment of asthma in patients 4 to 11 years of age: 40 mcg or 80 mcg twice daily.

Treatment of asthma in patients 12 years of age and older: 40 mcg, 80 mcg, 160 mcg, or 320 mcg twice daily

Mechanism of Action

Airway inflammation is known to be an important component in the pathogenesis of asthma. Inflammation occurs in both large and small airways. Corticosteroids have multiple anti-inflammatory effects, inhibiting both inflammatory cells and release of inflammatory mediators. It is presumed that these anti-inflammatory actions play an important role in the efficacy of beclomethasone dipropionate in controlling symptoms and improving lung function in asthma. Inhaled beclomethasone dipropionate probably acts topically at the site of deposition in the bronchial tree after inhalation. (from Qvar Prescribing Information)

Clinical Trial Results

The safety and efficacy of Qvar Redihaler were evaluated in 1,858 patients with asthma. The development program included 2 confirmatory trials of 12 weeks duration and 1 confirmatory trial of 6 weeks duration in patients 12 years of age and older, and 1 confirmatory trial of 12 weeks duration in patients 4 to 11 years of age. The efficacy of Qvar Redihaler is based primarily on the confirmatory trials described below.

Trials in the Maintenance Treatment of Asthma Adult and Adolescent Patients 12 Years of Age and Older

Two confirmatory clinical trials were conducted comparing Qvar Redihaler with placebo in adult and adolescent patients with persistent asthma (Trial 1 and Trial 2).

Trial 1: This randomized, double-blind, parallel-group, placebo-controlled, 12-week, efficacy and safety trial compared Qvar Redihaler 40 and 80 mcg given as 1 inhalation twice daily with placebo in adult and adolescent patients with persistent symptomatic asthma despite low-dose inhaled corticosteroid or non-corticosteroid asthma therapy. Patients aged 12 years and older who met the entry criteria including FEV1 40-85 percent of predicted normal, reversible bronchoconstriction of 15% with short-acting inhaled beta-agonist entered a 14-21 day run-in period. 270 patients (104 previously treated with inhaled corticosteroids) who met all the randomization criteria including asthma symptoms and rescue medication use were discontinued from asthma maintenance medication and randomized equally to treatment with Qvar Redihaler 80 mcg/day, Qvar Redihaler 160 mcg/day or placebo. Baseline FEV1 values were similar across treatments. The primary endpoint for this trial was the standardized baseline-adjusted trough morning forced expiratory volume in 1 second (FEV1) area under the effect curve from time zero to 12 weeks [FEV1 AUEC(0-12wk)]. Patients in both treatment groups had significantly greater improvements in trough FEV1 compared to placebo (Qvar Redihaler 80 mcg/day, LS mean change of 0.124 L and Qvar Redihaler 160 mcg/day, LS mean change of 0.116 L over 12 weeks). Both doses of Qvar Redihaler were effective in improving asthma control with significantly greater improvements in FEV1 and morning PEF when compared to placebo. Reduction in asthma symptoms was also supportive of the efficacy of Qvar Redihaler.

Trial 2: This randomized, double-blind, parallel-group, placebo-controlled, 6-week, efficacy and safety trial compared Qvar Redihaler 40 and 80 mcg given as 4 inhalations twice daily and placebo in adult and adolescent patients with persistent symptomatic asthma despite treatment with non-corticosteroid, inhaled corticosteroids (with or without a long acting beta agonist [LABA]), or combination asthma therapy. The study also included a reference treatment group, QVAR® Inhalation Aerosol (QVAR MDI) 40 mcg, 4 inhalations twice daily. Patients aged 12 years and older who met the entry criteria including FEV1 50-90% predicted normal, reversible bronchoconstriction of at least 10% with short-acting inhaled beta-agonist discontinued baseline asthma treatment and entered a 2-4 week run-in period. 425 patients (257 previously treated with ICS with or without LABA) who met all the randomization criteria including FEV1 of 40-85% predicted and 15% reversibility with short-acting inhaled beta-agonist, and asthma symptoms were randomized equally to Qvar Redihaler 320 mcg/day, Qvar Redihaler 640 mcg/day, QVAR MDI 320 mcg/day or placebo. Baseline FEV1 values were similar across treatments. The primary endpoint for this trial was the standardized baseline-adjusted trough morning forced expiratory volume in 1 second (FEV1) area under the effect curve from time zero to 6 weeks [FEV1 AUEC(0-6wk)]. Patients in both treatment groups had significantly greater improvements in trough FEV1 compared to placebo (Qvar Redihaler 320 mcg/day, LS mean change of 0.144 L and Qvar Redihaler 640 mcg/day, LS mean change of 0.150 L over 6 weeks). Treatment with QVAR MDI was similar. The change from baseline in morning FEV1 during the trial is displayed in Figure 2. Both doses of Qvar Redihaler were effective in improving asthma control with significantly greater improvements in FEV1, morning PEF, weekly average of daily trough morning FEV1, reduced rescue medication use and improved asthma symptom scores than with placebo. Similar results were demonstrated with QVAR MDI.