24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003 and Placebo MDI

Phase 3

Completed

• Conditions: COPD
• Interventions: Drug: GFF MDI (PT003); Drug: Placebo MDI

• Registration Number: NCT02347085
• Lead Sponsor: Pearl Therapeutics, Inc.

Brief Summary

Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003 and Placebo MDI

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-27
• Study Start: 2015-02-01
• Primary Completion: 2015-06-01
• Study Completion: 2015-06-01
• Results First Submitted: 2016-06-03
• Results First Submitted QC: 2017-03-07
• Results First Posted: 2017-04-19
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-19
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• At least 40 years of age and no older than 80 at Screening
• Women of non-child bearing potential or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly Screening until 14 days after final visit
• 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
• Pre- and post-bronchodilator FEV1/FVC ratio of <0.70
• Post-bronchodilator FEV1 must be <80% predicted normal value, calculated using NHANES III reference equations, and the measured FEV1 must also be ≥750 mL if FEV1 <30% of predicted normal value

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
• 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 Screening or during the Screening Period
• 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 Screening or during the Screening Period
• Subjects who have clinically significant uncontrolled hypertension.
• Subjects who have cancer that has not been in complete remission for at least five years
• Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥1.5 times upper limit of normal at Screening and on repeat testing
• Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible
• Subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator. Subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening are excluded from the study
• Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GFF MDI (PT003)	GFF MDI (PT003)	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) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol

Primary Outcome Measures

Name	Time	Method
FEV1 AUC0-24 on Day 29	Day 29	Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC)0-24 on Day 29

Secondary Outcome Measures

Name	Time	Method
Peak Change From Baseline in FEV1 on Day 29	Day 29	Peak Change From Baseline in FEV1 following the morning dose on Day 29
Morning Pre-Dose Trough FEV1 on Day 29	Day 29	Morning Pre-Dose Trough FEV on Day 29
Morning Pre-Dose Trough FEV1 on Day 30	Day 30	Morning Pre-Dose Trough FEV1 on Day 30
FEV1 AUC12-24 on Day 29	Day 29	FEV1 AUC12-24 on Day 29
FEV1 AUC0-12 on Day 29	Day 29	FEV1 AUC0-12 on Day 29
Peak Change From Baseline in Inspiratory Capacity (IC) Following the Evening Dose on Day 29	Day 29	Peak Change from Baseline in Inspiratory Capacity (IC) following the evening dose on Day 29
Peak Change From Baseline in IC Following the Morning Dose on Day 29	Day 29	Peak Change from Baseline in IC following the morning dose on Day 29