Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01085045
Last Updated: 2017-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
118 participants
INTERVENTIONAL
2010-03-31
2010-11-30
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
TRIPLE
Study Groups
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Inhaled PT003 (Dose 1)
PT003 MDI Dose 1
PT003 MDI
Inhaled PT003 MDI administered as two puffs BID for 7 days
Inhaled PT003 (Dose 2)
PT003 MDI Dose 2
PT003 MDI
Inhaled PT003 MDI administered as two puffs BID for 7 days
Inhaled PT005 (Dose 1)
PT005 MDI Dose 1
PT005 MDI
Inhaled PT005 MDI administered as two puffs BID for 7 days
Inhaled PT005 (Dose 2)
PT005 MDI Dose 2
PT005 MDI
Inhaled PT005 MDI administered as two puffs BID for 7 days
Inhaled Placebo
Placebo MDI
Placebo MDI
Inhaled placebo administered as two puffs BID for 7 days
Tiotropium bromide 18 μg (Spiriva Handihaler®)
Tiotropium Bromide inhalation powder
Tiotropium bromide 18 μg (Spiriva Handihaler®)
Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Formoterol fumarate inhalation powder 12 μg
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days
Inhaled PT001 (Dose 1)
PT001 MDI Dose 1
PT001 MDI
Inhaled PT001 MDI administered as two puffs BID for 7 days
Interventions
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PT003 MDI
Inhaled PT003 MDI administered as two puffs BID for 7 days
PT005 MDI
Inhaled PT005 MDI administered as two puffs BID for 7 days
Placebo MDI
Inhaled placebo administered as two puffs BID for 7 days
Tiotropium bromide 18 μg (Spiriva Handihaler®)
Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days
PT001 MDI
Inhaled PT001 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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Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
American Health Research
Charlotte, North Carolina, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Austrials
Caringbah, New South Wales, Australia
Woolcock
Glebe, New South Wales, Australia
Austrials
Hornsby, New South Wales, Australia
Austrials
Auchenflower, Queensland, Australia
Q-Pharm
Herston, Queensland, Australia
Respiratory Research Foundation - Burnside War Memorial Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Lung Institute of WA
Nedlands, Western Australia, Australia
Greenlane Clinical Centre
Epsom, Auckland, New Zealand
NZ Respiratory & Sleep Institute
Greenlane East, Auckland, New Zealand
Waikato Hospital
Hamilton, Waikato Region, New Zealand
P3 Research
Crofton Downs, Wellington Region, New Zealand
Countries
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References
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Reisner C, Fabbri LM, Kerwin EM, Fogarty C, Spangenthal S, Rabe KF, Ferguson GT, Martinez FJ, Donohue JF, Darken P, St Rose E, Orevillo C, Strom S, Fischer T, Golden M, Dwivedi S. A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease. Respir Res. 2017 Jan 6;18(1):8. doi: 10.1186/s12931-016-0491-8.
Other Identifiers
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PT0031002
Identifier Type: -
Identifier Source: org_study_id
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