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

Pearl Therapeutics

Status and phase

Completed

Phase 3

Conditions

COPD

Treatments

Drug: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler

Study type

Interventional

Funder types

Industry

Identifiers

NCT02268396

PT003016-00

Details and patient eligibility

About

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.

Enrollment

138 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.