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

Study identifier:PT003011-00

ClinicalTrials.gov identifier:NCT02347072

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

COPD

Phase

Phase 3

Healthy volunteers

Study drug

GFF MDI (PT003), Placebo MDI, Spiriva® Respimat® (Tiotropium Bromide)

Sex

All

Actual Enrollment

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 01 Feb 2015

Primary Completion Date: 01 Aug 2015

Study Completion Date: 01 Mar 2016

Study design

Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2019 by Pearl Therapeutics, Inc.

Collaborators

Inclusion and exclusion 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.

No locations available

Arms	Assigned Interventions
Experimental: GFF MDI (PT003) Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)	-
Placebo Comparator: Placebo MDI Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol	-
Active Comparator: Spiriva® Respimat® (Tiotropium Bromide) Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)	Drug: Spiriva® Respimat® (Tiotropium Bromide) Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)

Documents available

PT003011_ Protocol FINAL_31Dec14_Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

Daniele Tompkins

862-777-8059

Investigators

Principal Investigator

Colin Reisner

Pearl Therapeutics