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

NCT02268396 | Completed Phase 3 Results

• 1 other identifier: PT003016-00
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 10

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler

EXPERIMENTAL

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

Drug: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler

Interventions

Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler DRUG

GFF MDI administered as 2 inhalations BID

Also known as: GFF MDI, PT003

Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (10)

Pearl Investigative Site

Clearwater, Florida, United States

Location

Pearl Investigative Site

Tampa, Florida, United States

Location

Pearl Investigative Site

Winter Park, Florida, United States

Location

Pearl Investigative Site

Charlotte, North Carolina, United States

Location

Pearl Investigative Site

Columbus, Ohio, United States

Location

Pearl Investigative Site

Medford, Oregon, United States

Location

Pearl Investigative Site

Greenville, South Carolina, United States

Location

Pearl Investigative Site

Rock Hill, South Carolina, United States

Location

Pearl Investigative Site

Spartanburg, South Carolina, United States

Location

Pearl Investigative Site

Richmond, Virginia, United States

Location

Related Publications (1)

• 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.

  PMID: 30335559 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Colin Reisner, MD, FCCP, FAAAAI
• Organization: Pearl Therapeutics Inc

creisner@pearltherapeutics.com

973-975-0320

Study Officials

• Colin Reisner, MD

  Pearl Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 20, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 23, 2016
• Results First Posted: December 23, 2016

Record last verified: 2016-10

Locations

US (10)