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

COPD Clinical Trial

Official title:

A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Single-Center Study to A Study to Assess the Effects of PT003 and Placebo MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024346
• Other study ID #: PT003018
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2017
• Last updated: February 13, 2017
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Single-Center Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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 one of the following acceptable contraceptive methods used consistently and correctly as outlined below

• 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 and FEV1 must be <65% predicted normal value calculated using NHANES III reference equations.

• At Visit 1, post-bronchodilator FEV1/FVC ratio of <70% and FEV1 must be =30% to <65% predicted normal value, calculated using NHANES III reference equations.

Exclusion criteria:

• 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 ß2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.

Please refer to the study protocol for the complete inclusion criteria list.

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• GFF MDI (PT003) 14.4/9.6µg
Glycopyrronium and Formoterol Fumarate
• Placebo MDI
Glycopyrronium and Formoterol Fumarate

Locations

Country	Name	City	State
Belgium	Pearl Investigator Site	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific airway volume (siVaw)		9 weeks
Primary	Specific airway resistance (siRaw)		9 weeks
Secondary	Airway volume (iVaw)	Airway volume (iVaw)	9 weeks
Secondary	Airway resistance (iRaw)	Airway resistance (iRaw)	9 weeks
Secondary	Forced expiratory volume in one second (FEV1)	Forced expiratory volume in one second (FEV1)	9 weeks
Secondary	Functional Residual Capacity (FRC)	Functional Residual Capacity (FRC)	9 weeks