Status:
COMPLETED
Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD
Lead Sponsor:
Pearl Therapeutics, Inc.
Conditions:
COPD
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT02268396
Start Date
November 1 2014
End Date
May 1 2015
Last Update
December 23 2016
Active Locations (10)
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1
Pearl Investigative Site
Clearwater, Florida, United States
2
Pearl Investigative Site
Tampa, Florida, United States
3
Pearl Investigative Site
Winter Park, Florida, United States
4
Pearl Investigative Site
Charlotte, North Carolina, United States