A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD

NCT02937584 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PT003019
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after approximately two weeks treatment.

Conditions

COPD, Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Specific Image-Based Airway Volume (siVaw)

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

  Baseline, Day 15

• Specific Image-based Airway Resistance (siRaw)

  Specific image-based airway resistance (siRaw). Average across lobes, adjusted for lobe volume. Ratio to baseline.

  Baseline, Day 15

Secondary Outcomes (4)

• Image-based Airway Volume (iVaw)

  Baseline, Day 15

• Image-based Airway Resistance (iRaw)

  Baseline, Day 15

• FEV1

  Baseline, Day 15

• Functional Residual Capacity (FRC)

  Baseline, Day 15

Study Arms (2)

GP MDI (PT001) 14.4 μg

EXPERIMENTAL

Glycopyrronium

Drug: GP MDI (PT001) 14.4 μg

FF MDI (PT005) 9.6 μg

EXPERIMENTAL

Formoterol Fumarate

Drug: FF MDI (PT005) 9.6 μg

Interventions

GP MDI (PT001) 14.4 μg DRUG

Glycopyrronium

GP MDI (PT001) 14.4 μg

FF MDI (PT005) 9.6 μg DRUG

Formoterol Fumarate

FF MDI (PT005) 9.6 μg

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 use acceptable contraceptive methods used consistently and correctly
• 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 FEV1must be \>30% and \<80% predicted normal value, calculated using The Third National Health and Nutrition Examination Survey (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 (2)

Research Site

Edegem, 2650, Belgium

Location

Research Site

Erpent, 5101, Belgium

Location

Related Links

• Related Info
• Related Info

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: Stephan Stenglein, MD
• Organization: AstraZeneca

stephan.stenglein@astrazeneca.com

+46 (0)31 776 1000

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 18, 2016
• Study Start: December 29, 2016
• Primary Completion: May 28, 2018
• Study Completion: May 28, 2018
• Last Updated: July 24, 2019
• Results First Posted: July 24, 2019

Record last verified: 2019-06

Locations

BE (2)