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

NCT02347072 | Completed Phase 3 Results

• 1 other identifier: PT003011-00
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24

  Normalized 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 Outcomes (8)

• 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

Study Arms (3)

GFF MDI (PT003)

EXPERIMENTAL

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

Drug: GFF MDI (PT003)

Placebo MDI

PLACEBO COMPARATOR

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

Drug: Placebo MDI

Spiriva® Respimat® (Tiotropium Bromide)

ACTIVE COMPARATOR

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

Drug: Spiriva® Respimat® (Tiotropium Bromide)

Interventions

GFF MDI (PT003) DRUG

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

GFF MDI (PT003)

Placebo MDI DRUG

Also known as: Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol

Placebo MDI

Spiriva® Respimat® (Tiotropium Bromide) DRUG

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

Spiriva® Respimat® (Tiotropium Bromide)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Related Publications (1)

• Reisner C, Gottschlich G, Fakih F, Koser A, Krainson J, Delacruz L, Arora S, Feldman G, Pudi K, Siddiqui S, Orevillo C, Maes A, St Rose E, Martin U. 24-h bronchodilation and inspiratory capacity improvements with glycopyrrolate/formoterol fumarate via co-suspension delivery technology in COPD. Respir Res. 2017 Aug 18;18(1):157. doi: 10.1186/s12931-017-0636-4.

  PMID: 28821260 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Colin Reisner, MD, FCCP, FAAAAI
• Organization: Pearl Therapeutics Inc.

creisner@pearltherapeutics.com

650-350-2600

Study Officials

• Colin Reisner, MD

  Pearl Therapeutics

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 27, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 19, 2017
• Results First Posted: April 19, 2017

Record last verified: 2017-03