What we are studying
The purpose of this study is to see if BFF MDI (PT009), and FF MDI (PT005) have an effect on the rate of COPD exacerbations (worsening of COPD symptoms). This is a research study to test investigational drugs for which the study sponsor, Pearl Therapeutics, plans to seek approval from the US Food and Drug Administration (FDA) and Regulatory Authorities which approve medicines for human use in other countries. Pearl Therapeutics is developing two investigational products for the treatment of COPD. These products are investigational because they are not approved by the US FDA or any international Regulatory Authorities for commercial use or sale. The two investigational products are: 1) an orally inhaled (breathed through the mouth) combination of budesonide and formoterol fumarate called Budesonide and Formoterol Fumarate Inhalation Aerosol Metered Dose Inhaler (also known as BFF MDI or PT009) and 2) an orally inhaled (breathed through the mouth) drug called Formoterol Fumarate Inhalation Aerosol Metered Dose Inhaler (also known as FF MDI or PT005). In this study, Ventolin® HFA will be used as a rescue inhaler throughout the study for the immediate relief of your COPD symptoms. Albuterol (salbutamol) Sulfate (Ventolin HFA Inhalation Aerosol) is approved by the U.S. FDA and Regulatory Authorities in other countries as a medication given as an inhaler to control the symptoms of COPD. Ventolin HFA is made by GlaxoSmithKline and not by Pearl Therapeutics.
$1,007 for completing all study visits. Withdrawal from the study for any reason will result in payment of each completed visit. Visit 1(screening), 2, 3, 4, 6, 9, 11, 14: $82.00. Visit 5, 7, 8, 10, 12, 13: $58.50.