Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD

Completed · Phase 3

Conditions studied: COPD

In brief

This is an open-label, multi-center study to evaluate the accuracy, reliability and functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment Period.

Key facts

Study ID

NCT02268396

Run by

Pearl Therapeutics, Inc.

People needed

138

Starts

2014-11-01

Expected to finish

2015-05-01

Last updated by the study team

2016-12-23

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Give their signed written informed consent to participate.
• 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.

You may not qualify if…

• Pregnancy, nursing females or subjects trying to conceive.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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