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

Phase 3

Completed

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.

Detailed Description: Enrolled patients with COPD who were randomized to receive either PT003 MDI or Placebo MDI first and then crossed over to receive the opposite intervention. The study consisted of 2 treatment periods of 14 days separated by a washout period of 5-21 days.

Recruitment & 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 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.

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 β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
GFF MDI, 14.4/9.6μg	GFF MDI (PT003) 14.4/9.6μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)
Placebo MDI	Placebo MDI	Placebo Metered Dose Inhaler (MDI)

Primary Outcome Measures

Name	Time	Method
Specific Airway Volume (siVaw)	Day 15	Specific image-based airway volume. Average across lobe, adjusted for lobe volume
Specific Airway Resistance (siRaw)	Day 15	Specific image-based airway resistance. Average across lobes, adjusted for lobe volume

Secondary Outcome Measures

Name	Time	Method
Airway Resistance (iRaw)	Day 15	iRaw represents the airway resistance, averaged across lobes, without correction for lung lobe volume
Airway Volume (iVaw)	Day 15	iVaw represents the airway Volume, averaged across lobes, without correction for lung lobe volume
Change From Baseline in FEV1 (L) at Day 15	Baseline and Day 15	Change from baseline in Forced Expiratory Volume at 1 second
Change From Baseline in FRC (L) at Day 15	Baseline and Day 15	Change from baseline in Functional Residual Capacity