PT005 MDI Dose Ranging Versus Foradil Aerolizer Study

Phase 2

Completed

Interventions: Drug: Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Drug: PT005 MDI
Other: Placebo MDI

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Recruitment & Eligibility

Inclusion Criteria

Signed written informed consent
40 - 80 years of age
Clinical history of COPD with airflow limitation that is not fully reversible
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
Able to change COPD treatment as required by protocol
Demonstratead reversibility to short acting beta agonist (Ventolin HFA) (> 12% and >150 mL improvement in baseline FEV1 approximately 30 minutes following administration of 4 puffs of Ventolin HFA or > 200 mL improvement in baseline FEV1 30 minutes following administration of 2 puffs of Ventolin HFA)

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 3 months of Screening
Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
Cancer that has not been in complete remission for at least 5 years
Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives

Other inclusion/exclusion criteria as defined by the protocol

Arm && Interventions

Group	Intervention	Description
Formoterol Fumarate 24 μg (Foradil® Aerolizer®)	Formoterol Fumarate 24 μg (Foradil® Aerolizer®)	Formoterol fumarate inhalation powder 24 μg
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)	Formoterol Fumarate 12 μg (Foradil® Aerolizer®)	Formoterol fumarate inhalation powder 12 μg
PT005 MDI (Dose 3)	PT005 MDI	PT005 MDI (Dose 3)
PT005 MDI (Dose 2)	PT005 MDI	PT005 MDI (Dose 2)
PT005 MDI (Dose 1)	PT005 MDI	PT005 MDI (Dose 1)
Placebo MDI	Placebo MDI	Placebo MDI

Primary Outcome Measures

Name	Time	Method
Change in FEV1 AUC0-12 from test day baseline across the three doses of inhaled PT005 compared with placebo	1 Day	The primary objective of this study is to demonstrate efficacy relative to placebo of PT005 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this study. To this end, each dose of PT005 MDI will be compared to placebo with respect to the primary efficacy endpoint, the change in FEV1 AUC0-12 from baseline.

Secondary Outcome Measures

Name	Time	Method
Characterize the dose-response curve of PT005 MDI	1 Day	The secondary objective of the study is to characterize the dose-response curve of PT005 MDI, to conduct a non-inferiority assessment comparing PT005 MDI within the range of doses evaluated in this study to open-label Foradil Aerolizer 12 µg, and to select the most appropriate dose of PT005 MDI to carry forward into Phase III clinical studies
Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events	1 Day