Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT02196077
Last Updated: 2018-06-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2014-08-01
2015-03-01
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
DOUBLE
Study Groups
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BFF MDI 320/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BFF MDI 320/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BFF MDI 160/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI)160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BFF MDI 160/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BFF MDI 80/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BFF MDI 80/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BD MDI 320 μg
Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)
BD MDI 320 μg
Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)
FF MDI 9.6 μg
Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)
FF MDI 9.6 μg
Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)
Interventions
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BFF MDI 320/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BFF MDI 160/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BFF MDI 80/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BD MDI 320 μg
Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)
FF MDI 9.6 μg
Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)
Eligibility Criteria
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Inclusion Criteria
* COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
* Tobacco Use: Current or former smokers with a history of at least 10 pack years of cigarette smoking
* Women of non-childbearing potential or medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
* Severity of Disease: Subjects with an established clinical history of COPD and severity defined as: FEV1/forced vital capacity (FVC) ratio of \<0.70; At Screening (Visit 1a/b), post bronchodilator FEV1 must be \<80% predicted normal value, calculated using NHANES III (Third National Health and Nutrition Examination Survey) reference equations; the measured FEV1 must also be ≥30% of predicted normal value; at Visit 2, the average of the 60 minutes and 30 minutes pre dose FEV1 assessments must be \<80% predicted normal value calculated using NHANES III reference equations
* Screening clinical laboratory tests must be acceptable to the Investigator
* Screening ECG must be acceptable to the Investigator
* Chest x ray or computerized tomography (CT) scan within 6 months prior to Visit 1a must be acceptable to the Investigator.
Exclusion Criteria
* Pregnancy, nursing female subjects, or subjects trying to conceive, or not using medically acceptable form of contraception
* Asthma: Subjects who have a primary diagnosis of asthma (Note: Subjects with a prior history of asthma are eligible if COPD is currently their primary diagnosis).
* Alpha 1 Antitrypsin Deficiency: Subjects who have alpha 1 antitrypsin deficiency as the cause of COPD -Active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, and uncontrolled sleep apnea (ie., in the opinion of the Investigator severity of the disorder would impact the conduct of the study)-
* Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
* Poorly Controlled COPD
* History of ECG abnormalities
* Cancer not in complete remission for at least 5 years
* Clinically significant, symptomatic prostatic hypertrophy
* Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
* Clinically significant bladder neck obstruction or urinary retention
* Inadequately treated glaucoma
* History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study
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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Shahid Siddiqui, MD, MHSA
Role: STUDY_DIRECTOR
Pearl Therapeutics, Inc.
Locations
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Pearl Investigative Site
Rolling Hills Estates, California, United States
Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Panama City, Florida, United States
Pearl Investigative Site
Tampa, Florida, United States
Pearl Investigative Site
Winter Park, Florida, United States
Pearl Investigative Site
Edina, Minnesota, United States
Pearl Investigative Site
Minneapolis, Minnesota, United States
Pearl Investigative Site
Woodbury, Minnesota, United States
Pearl Investigative Site
Saint Charles, Missouri, United States
Pearl Investigative Site
Charlotte, North Carolina, United States
Pearl Investigative Site
Cincinnati, Ohio, United States
Pearl Investigative Site
Columbus, Ohio, United States
Pearl Investigative Site
Dublin, Ohio, United States
Pearl Investigative Site
Medford, Oregon, United States
Pearl Investigative Site
Easley, South Carolina, United States
Pearl Investigative Site
Greenville, South Carolina, United States
Pearl Investigative Site
Spartanburg, South Carolina, United States
Countries
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Related Links
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Other Identifiers
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PT009001
Identifier Type: -
Identifier Source: org_study_id
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