PT003 MDI Dose Confirmation Study



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 80
Updated:4/28/2017
Start Date:June 2011
End Date:November 2011

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A Randomized, Double Blind, Chronic Dosing (7 Days), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls

The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its
individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic
obstructive pulmonary disease (COPD).


Key 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

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 in the protocol
We found this trial at
13
sites
Spartanburg, South Carolina
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Spartanburg, SC
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Brooklyn, New York
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Brooklyn, NY
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Charlotte, North Carolina
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Charlotte, NC
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Cincinnati, Ohio
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Cincinnati, OH
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Clearwater, Florida
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Clearwater, FL
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Colorado Springs, Colorado
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Colorado Springs, CO
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Medford, Oregon 97504
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Medford, OR
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Minneapolis, Minnesota
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from
Minneapolis, MN
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Pensacola, Florida
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Pensacola, FL
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Rancho Mirage, California
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Rancho Mirage, CA
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Stockbridge, Georgia 30281
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from
Stockbridge, GA
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Waterbury, Connecticut
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from
Waterbury, CT
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Winston-Salem, North Carolina
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from
Winston-Salem, NC
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