Title
Efficacy and Safety of Two Doses of Formoterol Fumarate MDI (PT005) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), Compared to Foradil® Aerolizer® as an Active Control
A Phase IIb, Multi-center, Randomized, Double-blind, Placebo-controlled, Multi-dose, Four-period, Cross-over Study of Two Doses of Formoterol Fumarate MDI (PT005; 7.2 and 9.6 µg Ex-actuator), Administered Twice Daily for 1 Week in Patients With Moderate to Very Severe COPD, Compared to Open Label Marketed Formoterol Fumarate Inhalation Powder (Foradil® Aerolizer®, 12 µg) as an Active Control
Phase
Phase 2Lead Sponsor
Pearl TherapeuticsStudy Type
InterventionalStatus
WithdrawnIndication/Condition
COPDIntervention/Treatment
formoterol ...Study Participants
0The purpose of this study is to evaluate the safety and efficacy of inhaled formoterol fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
inhaled, twice daily for 1 week duration
inhaled, twice daily for 1 week duration
inhaled, twice daily for 1 week duration
Key Inclusion Criteria: Signed written informed consent 40 - 80 years of age Fluency in written and spoken English Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods Current/former smokers with at least a 10 pack-year history of cigarette smoking A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70 A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values Competent at using the inhalation device Key Exclusion Criteria: Women who are pregnant or lactating Primary diagnosis of asthma Alpha-1 antitrypsin deficiency as the cause of COPD Active pulmonary diseases Prior lung volume reduction surgery Abnormal chest X-ray (or CT scan) not due to the presence of COPD Hospitalized due to poorly controlled COPD within 12 weeks of Screening Poorly controlled COPD, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician within 6 weeks of screening or between screening and visit 2 Lower respiratory tract infection requiring antibiotics within 6 weeks of screening Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG or uncontrolled hypertension) Positive Hepatitis B surface antigen or Hepatitis C antibody Cancer that has not been in complete remission for at least 5 years History of hypersensitivity to any beta2-agonists or any study drug component History of severe milk protein allergy Known or suspected history of alcohol or drug abuse Medically unable to withhold short acting bronchodilators for 8-hours Use of prohibited medications prior to screening and during the study as specified in the protocol Receiving long-term-oxygen or nocturnal oxygen therapy for >12 hours a day Participation in acute phase of pulmonary rehabilitation within 4 weeks of screening or will enter acute phase of pulmonary rehabilitation program during study Unable to comply with study procedures Prior participation in a Pearl PT005 study Requires use of a spacer due to poor hand-to-breath coordination
