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)

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Clearwater, Florida, United States
      • Pearl Investigative Site
    • Tampa, Florida, United States
      • Pearl Investigative Site
    • Winter Park, Florida, United States
      • Pearl Investigative Site
  • North Carolina
    • Charlotte, North Carolina, United States
      • Pearl Investigative Site
  • Ohio
    • Columbus, Ohio, United States
      • Pearl Investigative Site
  • Oregon
    • Medford, Oregon, United States
      • Pearl Investigative Site
  • South Carolina
    • 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
  • Virginia
    • Richmond, Virginia, United States
      • Pearl Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler; Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler (GFF MDI), PT003	Drug: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler; GFF MDI administered as 2 inhalations BID; Other Names: GFF MDI, PT003

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Over the life of the canister/120 puffs - up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit	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	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	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	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.	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	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 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	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

Collaborators and Investigators

• Sponsor: Pearl Therapeutics, Inc.
• Investigators: Study Director: Colin Reisner, MD, Pearl Therapeutics

Publications and helpful links

General Publications

• Pudi K, Feldman G, Fakih F, Mack P, Maes A, Siddiqui S, St Rose E, Reisner C. An Open-Label Study Evaluating the Performance of the Dose Indicator in a Metered Dose Inhaler Delivering Glycopyrrolate and Formoterol Fumarate in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease. J Aerosol Med Pulm Drug Deliv. 2019 Feb;32(1):40-46. doi: 10.1089/jamp.2018.1466. Epub 2018 Nov 1.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 15, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Estimate): December 23, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Glycopyrrolate; Formoterol Fumarate
• Other Study ID Numbers: PT003016-00