A Study to Assess the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

NCT02643082 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PT003018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance With Moderate to Severe COPD.

Conditions

COPD

Outcome Measures

Primary Outcomes (2)

• Specific Airway Volume (siVaw)

  Specific image-based airway volume. Average across lobe, adjusted for lobe volume

  Day 15

• Specific Airway Resistance (siRaw)

  Specific image-based airway resistance. Average across lobes, adjusted for lobe volume

  Day 15

Secondary Outcomes (4)

• Airway Resistance (iRaw)

  Day 15

• Airway Volume (iVaw)

  Day 15

• Change From Baseline in FEV1 (L) at Day 15

  Baseline and Day 15

• Change From Baseline in FRC (L) at Day 15

  Baseline and Day 15

Study Arms (2)

GFF MDI, 14.4/9.6μg

EXPERIMENTAL

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)

Drug: GFF MDI (PT003) 14.4/9.6μg

Placebo MDI

PLACEBO COMPARATOR

Placebo Metered Dose Inhaler (MDI)

Drug: Placebo MDI

Interventions

GFF MDI (PT003) 14.4/9.6μg DRUG

Glycopyrronium and Formoterol Fumarate

Also known as: GFF

GFF MDI, 14.4/9.6μg

Placebo MDI DRUG

Comparator: Placebo MDI which contains no active ingredients

Also known as: Placebo

Placebo MDI

Eligibility Criteria

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

You may qualify if:

• Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative urine pregnancy test at Visit 1 and agrees to an acceptable method of contraception
• 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.
• At Visit 1, FEV1/FVC ratio must be \<0.70
• At Visit 1, post-bronchodilator FEV1/FVC ratio of \<70% and FEV1 must be 30% to 80% before predicted normal value, calculated using NHANES III reference equations.

You may not qualify if:

• Significant diseases other than COPD, i.e., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
• Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
• Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
• Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the run-in period (Visit 1 to Visit 2).
• Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the run-in period (Visit 1 to Visit 2).
• Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated.
• Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (1)

Research Site

Edegem, 2650, Belgium

Location

Related Publications (1)

• De Backer W, De Backer J, Vos W, Verlinden I, Van Holsbeke C, Clukers J, Hajian B, Siddiqui S, Jenkins M, Reisner C, Martin UJ. A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2018 Aug 30;13:2673-2684. doi: 10.2147/COPD.S171707. eCollection 2018.

  PMID: 30214185 DERIVED

Related Links

• Protocol with updated PDFA coverpage
• Updated version per comments from CT.gov
• Updated version per CT.gov comments
• Updated version per CT.gov comments
• Updated version per comments from CT.gov
• Updated version per CT.gov comments
• Updated version per comments from CT.gov
• Updated version per comments from CT.gov

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pearl Therapeutics, Inc.
• Organization: Pearl Therapeutics, Inc.

creisner@pearltherapeutics.com

650-305-2600

Study Officials

• Chad Orevillo

  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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 30, 2015
• Study Start: December 23, 2015
• Primary Completion: January 26, 2017
• Study Completion: January 26, 2017
• Last Updated: March 19, 2019
• Results First Posted: March 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)