Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2011-05-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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PT005 MDI (Dose 1)
PT005 MDI (Dose 1)
PT005 MDI
PT005 MDI taken as two inhalations
PT005 MDI (Dose 2)
PT005 MDI (Dose 2)
PT005 MDI
PT005 MDI taken as two inhalations
PT005 MDI (Dose 3)
PT005 MDI (Dose 3)
PT005 MDI
PT005 MDI taken as two inhalations
Placebo MDI
Placebo MDI
Placebo MDI
Matching placebo to PT005 MDI taken as two inhalations
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Formoterol fumarate inhalation powder 12 μg
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
Formoterol fumarate inhalation powder 24 μg
Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Interventions
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PT005 MDI
PT005 MDI taken as two inhalations
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Placebo MDI
Matching placebo to PT005 MDI taken as two inhalations
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
* 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)
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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Locations
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Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Tampa, Florida, United States
Pearl Investigative Site
Spartanburg, South Carolina, United States
Countries
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Other Identifiers
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PT005003
Identifier Type: -
Identifier Source: org_study_id