24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003, Open-Label Spiriva® Respimat® as an Active Control, and Placebo

A Randomized, Phase IIIb, Three-period, Three-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, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo

Sponsors

Lead Sponsor: Pearl Therapeutics, Inc.

Source Pearl Therapeutics, Inc.
Brief Summary

Randomized, Phase IIIb, Three-period, Three-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, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo.

Overall Status Completed
Start Date February 1, 2015
Completion Date March 1, 2016
Primary Completion Date August 1, 2015
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24 Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29
Secondary Outcome
Measure Time Frame
FEV1 AUC12-24 Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the evening dose on Day 29
FEV1 AUC0-12 Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the morning dose on Day 29
Peak Change From Baseline in FEV1 Evening Baseline and Day 29
Peak Change From Baseline in FEV1 Morning Baseline and Day 29
Morning Pre-Dose Trough FEV1 on Day 29 Day 29
Morning Pre-Dose Trough FEV1 on Day 30 Day 30
Peak Change From Baseline in IC (Inspiratory Capacity) Evening Baseline and Day 29
Peak Change From Baseline in IC Morning Baseline and Day 29
Enrollment 80
Condition
Intervention

Intervention Type: Drug

Intervention Name: GFF MDI (PT003)

Arm Group Label: GFF MDI (PT003)

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

Intervention Type: Drug

Intervention Name: Placebo MDI

Arm Group Label: Placebo MDI

Other Name: Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol

Intervention Type: Drug

Intervention Name: Spiriva® Respimat® (Tiotropium Bromide)

Description: Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)

Arm Group Label: Spiriva® Respimat® (Tiotropium Bromide)

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Colin Reisner, MD Study Chair Pearl Therapeutics
Verification Date

March 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 3
Arm Group

Label: GFF MDI (PT003)

Type: Experimental

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

Label: Placebo MDI

Type: Placebo Comparator

Description: Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol

Label: Spiriva® Respimat® (Tiotropium Bromide)

Type: Active Comparator

Description: Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov