Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD (telos)
Chronic Obstructive Pulmonary Disorder
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disorder focused on measuring COPD
Eligibility Criteria
Inclusion Criteria:
- Give their signed written informed consent to participate
- Are at least 40 years of age and no older than 80 years
- COPD patients who are symptomatic
- Must be receiving one or more inhaled bronchodilators as maintenance therapy
Exclusion Criteria:
- Current diagnosis of asthma,
- COPD due to α1-Antitrypsin Deficiency
- Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
- Long-term-oxygen therapy (≥ 12 hours a day).
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Other
BFF MDI 320/9.6 μg
BFF MDI 160/9.6 μg
FF MDI 9.6 μg
BD MDI 320 μg
Symbicort® TBH 400/12 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Budesonide and Formoterol Fumarate Inhalation Aerosol-80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Formoterol Fumarate Inhalation Aerosol-4.8 μg per actuation MDI/ 120 inhalations Taken as 2 inhalations BID
Budesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Symbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID