An Open-Label, Multi-Center, Dose Indicator Study of Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) in Adult Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Pearl Therapeutics, Inc.1 site in 1 country138 target enrollmentNovember 2014

ConditionsCOPD

InterventionsGlycopyrronium and Formoterol Fumarate Metered-dose Inhaler

DrugsGlycopyrronium and Formoterol Fumarate Metered-dose Inhaler

Overview

Phase: Phase 3
Intervention: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler
Conditions: COPD
Sponsor: Pearl Therapeutics, Inc.
Enrollment: 138
Locations: 1
Primary Endpoint: Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 subjects with moderate to very severe COPD over a 4-week Treatment Period.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

May 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pearl Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Give their signed written informed consent to participate.
•Are at least 40 years of age and no older than 80 at Visit
•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.
•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.

Arms & Interventions

Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler

Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler (GFF MDI), PT003

Intervention: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler

Outcomes

Primary Outcomes

Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count

Time Frame: Over the life of the canister/120 puffs - up to 4 weeks

Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit: ITT Population

Secondary Outcomes

Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit(Over the life of the canister/120 puffs - up to 4 weeks)
Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit(Over the life of the canister/120 puffs - up to 4 weeks)
Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit.(Over the life of the canister/120 puffs - up to 4 weeks)
Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount)(Over the life of the canister/120 puffs - up to 4 weeks)
Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count(Over the life of the canister/120 puffs - up to 4 weeks)