Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
185 participants
INTERVENTIONAL
2011-06-30
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
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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PT003 (Dose 1)
PT003 MDI Dose 1
PT003
PT003 MDI administered as two puffs BID for 7 days
PT003 (Dose 2)
PT003 MDI Dose 2
PT003
PT003 MDI administered as two puffs BID for 7 days
PT003 (Dose 3)
PT003 MDI Dose 3
PT003
PT003 MDI administered as two puffs BID for 7 days
PT003 (Dose 4)
PT003 MDI Dose 4
PT003
PT003 MDI administered as two puffs BID for 7 days
PT001
PT001 MDI
PT001
PT001 MDI administered as two puffs BID for 7 days
PT005
PT005 MDI
PT005
PT005 MDI administered as two puffs BID for 7 days
Interventions
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PT003
PT003 MDI administered as two puffs BID for 7 days
PT001
PT001 MDI administered as two puffs BID for 7 days
PT005
PT005 MDI administered as two puffs BID for 7 days
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
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
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, Inc.
Locations
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Pearl Investigative Site
Rancho Mirage, California, United States
Pearl Investigative Site
Colorado Springs, Colorado, United States
Pearl Investigative Site
Waterbury, Connecticut, United States
Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Pensacola, Florida, United States
Pearl Investigative Site
Stockbridge, Georgia, United States
Pearl Investigative Site
Minneapolis, Minnesota, United States
Pearl Investigative Site
Brooklyn, New York, United States
Pearl Investigative Site
Charlotte, North Carolina, United States
Pearl Investigative Site
Winston-Salem, North Carolina, United States
Pearl Investigative Site
Cincinnati, Ohio, United States
Pearl Investigative Site
Medford, Oregon, United States
Pearl Investigative Site
Spartanburg, South Carolina, United States
Countries
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References
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Reisner C, Pearle J, Kerwin EM, Rose ES, Darken P. Efficacy and safety of four doses of glycopyrrolate/formoterol fumarate delivered via a metered dose inhaler compared with the monocomponents in patients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2018 Jun 19;13:1965-1977. doi: 10.2147/COPD.S166455. eCollection 2018.
Other Identifiers
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PT003004
Identifier Type: -
Identifier Source: org_study_id
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