Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD
NCT ID: NCT02268396
Last Updated: 2016-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
138 participants
INTERVENTIONAL
2014-11-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler
Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler (GFF MDI), PT003
Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler
GFF MDI administered as 2 inhalations BID
Interventions
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Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler
GFF MDI administered as 2 inhalations BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are at least 40 years of age and no older than 80 at Visit 1.
* A female of non-child bearing potential or child bearing potential, has a negative serum pregnancy test, and agrees to approved contraceptive methods.
* COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society(ATS)/European Respiratory Society (ERS).
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
* FEV1/FVC ratio of \<0.70.
* Post-bronchodilator FEV1 must be ≥ 30% and \<80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations, and must also be greater than or equal to 750 mL.
* Subject is willing and, in the opinion of the Investigator, able to adjust current COPD therapy as required by the protocol.
Exclusion Criteria
* Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study.
* Current primary diagnosis of asthma.
* History of ECG abnormalities.
* Poorly controlled or worsening COPD prior to Screening or during the Screening Period.
* Clinically significant bladder neck obstruction or urinary retention.
* Male subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening.
* Cancer that has not been in complete remission for at least five years.
* Inadequately treated glaucoma.
* History of allergic reaction or hypersensitivity 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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Colin Reisner, MD
Role: STUDY_DIRECTOR
Pearl Therapeutics
Locations
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Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Tampa, Florida, United States
Pearl Investigative Site
Winter Park, Florida, United States
Pearl Investigative Site
Charlotte, North Carolina, United States
Pearl Investigative Site
Columbus, Ohio, United States
Pearl Investigative Site
Medford, Oregon, United States
Pearl Investigative Site
Greenville, South Carolina, United States
Pearl Investigative Site
Rock Hill, South Carolina, United States
Pearl Investigative Site
Spartanburg, South Carolina, United States
Pearl Investigative Site
Richmond, Virginia, United States
Countries
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References
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Pudi K, Feldman G, Fakih F, Mack P, Maes A, Siddiqui S, St Rose E, Reisner C. An Open-Label Study Evaluating the Performance of the Dose Indicator in a Metered Dose Inhaler Delivering Glycopyrrolate and Formoterol Fumarate in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease. J Aerosol Med Pulm Drug Deliv. 2019 Feb;32(1):40-46. doi: 10.1089/jamp.2018.1466. Epub 2018 Nov 1.
Other Identifiers
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PT003016-00
Identifier Type: -
Identifier Source: org_study_id