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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02268396

Enrollment

138

Registered

2014-10-20

Start date

2014-11-30

Completion date

2015-05-31

Last updated

2016-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

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.

Interventions

DRUGGlycopyrronium and Formoterol Fumarate Metered-dose Inhaler

GFF MDI administered as 2 inhalations BID

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count	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

Measure	Time frame	Description
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 whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight
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 whose number of actuations counted at the end of the study, using the lab-advanced dose indicator reading, was consistent (±20 actuations) with the number of actuations used as reported by the subject
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 whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight
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 devices where the dose indicator actuation count is \>20 less than the subject-reported actuation count (undercount)
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	Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count

Countries

United States

Participant flow

Recruitment details

Conducted at 10 study sites in the United states from November 2014 - January 2015. The entire study period was scheduled to take approximately 6 weeks for each individual subject. The study was anticipated to run for approximately 6 months.

Pre-assignment details

Study was an open-label, multi center study to evaluate the accuracy, reliability, and functionality of GFF MDI dose indicator in adult subjects with moderate to very severe COPD over a 4-week treatment period.

Participants by arm

Arm	Count
GFF MDI (PT003) GFF MDI 14.4/9.6 μg	138
Total	138

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	2 Subjects no Day 29 Assessment	2
Overall Study	Administrative	2
Overall Study	Adverse Event	3
Overall Study	Lost to Follow-up	2
Overall Study	Protocol-Specified Criteria	2
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	GFF MDI (PT003)
Age, Continuous	62.1 Years STANDARD_DEVIATION 8.3
Gender Female	68 Participants
Gender Male	70 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	10 / 138
serious Total, serious adverse events	3 / 138

Outcome results

Primary

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

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