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Pearl Therapeutics' Phase 2b Results Show a 50% Improvement in Lung Function with PT003 Compared to Spiriva® and Foradil® in Patients with COPD
Date:5/18/2011

l, two formulations of PT003 were studied, each containing 9.6 mcg FF plus one of two doses of GP: 36 mcg or 72 mcg. In addition, to investigate the effective dose range of FF MDI, a 7.2 mcg BID dose was also tested.  

One hundred eighteen patients were randomized in the Phase 2b study to receive four of the  following eight treatments  in a cross-over study: 36 mcg GP/9.6 mcg FF (PT003), 72 mcg GP/9.6 mcg FF (PT003), 36 mcg GP (PT001), 7.2 mcg FF (PT005) , 9.6 mcg FF (PT005), Spiriva, Foradil and placebo. Placebo, PT003, PT001 and PT005 were administered BID via HFA MDI for one week while Spiriva and Foradil were administered according to their approved label: 18 mcg once daily (via Handihaler® inhaler) and 12 mcg BID (via Aerolizer® inhaler), respectively, each for one week.

About COPD

Chronic obstructive pulmonary disease (COPD) is a preventable and treatable lung disease that is the fourth leading cause of death in the United States. Each year 12 million Americans are diagnosed with COPD and an additional 12 million Americans may have COPD but remain undiagnosed. Research shows that many do not get optimal treatment.

Bronchodilator medications are central to symptom management and are prescribed on an as-needed or regular basis to prevent or reduce symptoms. Long-acting inhaled bronchodilators have been shown to be most effective and convenient. Combining bronchodilators of different pharmacological classes, as recommended by The Global Initiative for Chronic Obstructive Lung Diseases (GOLD), has been shown to improve efficacy and may decrease the risk of side effects compared to increasing the dose of a single bronchodilator. As the course of COPD progresses, regular treatment with inhaled glucocorticosteroids may be added to bronchodilator treatment.
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