Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
237 participants
INTERVENTIONAL
2011-05-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PT005 MDI
PT005 MDI
PT005 MDI
PT005 MDI administered as two puffs BID for 14 days
PT001 MDI
PT001 MDI
PT001 MDI
PT001 MDI administered as two puffs BID for 14 days
PT003 MDI
PT003 MDI
PT003 MDI
PT003 MDI administered as two puffs BID for 14 days
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days
Interventions
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PT005 MDI
PT005 MDI administered as two puffs BID for 14 days
PT001 MDI
PT001 MDI administered as two puffs BID for 14 days
PT003 MDI
PT003 MDI administered as two puffs BID for 14 days
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Acceptable baseline (Visit 2) Holter monitor recording
Exclusion Criteria
* 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
* Clinically significant abnormal findings during the baseline Holter recording
* Patients with a pacemaker or ICD/CRT/CRT\_D devices
40 Years
80 Years
ALL
No
Sponsors
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Pearl Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Colin Reisner, M.D.
Role: STUDY_DIRECTOR
Pearl Therapeutics
Locations
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Pearl Investigative Site
Glendale, Arizona, United States
Pearl Investigative Site
Fullerton, California, United States
Pearl Investigative Site
Los Angeles, California, United States
Pearl Investigative Site
San Diego, California, United States
Pearl Investigative Site
Pensacola, Florida, United States
Pearl Investigative Site
Lafayette, Louisiana, United States
Pearl Investigative Site
North Dartmouth, Massachusetts, United States
Pearl Investigative Site
Livonia, Michigan, United States
Pearl Investigative Site
Medford, Oregon, United States
Pearl Investigative Site
San Antonio, Texas, United States
Pearl Investigative Site
Glebe, New South Wales, Australia
Pearl Investigative Site
Caboolture, Queensland, Australia
Pearl Investigative Site
Dawpark, South Australia, Australia
Pearl Investigative Site
Toorak Gardens, South Australia, Australia
Pearl Investigative Site
Heidelberg, Victoria, Australia
Pearl Investigative Site
Nedlands, Western Australia, Australia
Pearl Investigative Site
Caversham, Dunedin, New Zealand
Pearl Investigative Site
Private Bag, Hamilton, New Zealand
Pearl Investigative Site
Tauranga, North Island, New Zealand
Pearl Investigative Site
Newtown, Wellington Region, New Zealand
Countries
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References
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Ferguson GT, Reisner C, Pearle J, DePetrillo P, Maes A, Martin UJ. Cardiovascular safety profile of a fixed-dose combination of glycopyrrolate and formoterol fumarate delivered via metered dose inhaler using co-suspension delivery technology. Pulm Pharmacol Ther. 2018 Apr;49:67-74. doi: 10.1016/j.pupt.2018.01.007. Epub 2018 Feb 4.
Other Identifiers
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PT003003
Identifier Type: -
Identifier Source: org_study_id
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