Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT01587079 | Completed Phase 2 Results

• 1 other identifier: PT003005
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 19

Brief Summary

The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• FEV1 AUC 0-12 on Day 7

  FEV1 AUC 0-12

  Day 7

Secondary Outcomes (13)

• Peak Change From Baseline in FEV1 on Treatment Day 1

  Day 1

• Time to Onset of Action (>10% Improvement in FEV1) on Day 1

  Day 1

• Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1

  Day 1

• Peak Change From Baseline in Inspiratory Capacity on Day 1

  Day 1

• Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7

  Day 7

Study Arms (8)

PT003 (Dose 1)

EXPERIMENTAL

PT003 MDI Dose 1

Drug: PT003

PT003 (Dose 2)

EXPERIMENTAL

PT003 MDI Dose 2

Drug: PT003

PT003 (Dose 3)

EXPERIMENTAL

PT003 MDI Dose 3

Drug: PT003

PT003 (Dose 4)

EXPERIMENTAL

PT003 MDI Dose 4

Drug: PT003

PT003 (Dose 5)

EXPERIMENTAL

PT003 MDI Dose 5

Drug: PT003

PT001

EXPERIMENTAL

PT001 MDI

Drug: PT001

PT005

EXPERIMENTAL

PT005 MDI

Drug: PT005

Spiriva® Handihaler®

ACTIVE COMPARATOR

Tiotropium Bromide

Drug: Tiotropium inhalation powder

Interventions

PT003 DRUG

PT003 MDI administered as two puffs BID for 7 days

PT003 (Dose 1); PT003 (Dose 2); PT003 (Dose 3); PT003 (Dose 4); PT003 (Dose 5)

PT001 DRUG

PT001 MDI administered as two puffs BID for 7 days

PT001

PT005 DRUG

PT005 MDI administered as two puffs BID for 7 days

PT005

Tiotropium inhalation powder DRUG

Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days

Spiriva® Handihaler®

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent
• years of age
• Clinical history of COPD with airflow limitation that is not fully reversible
• Females of non-child bearing potential or females of child bearing potential with negative pregnancy test and acceptable contraceptive methods
• Current/former smokers with at least a 10 pack-year history of cigarette smoking
• A measured post-bronchodilator FEV1/FVC ratio of \< or = 0.70
• A measured post-bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values
• Able to change COPD treatment as required by protocol

You may not qualify if:

• Women who are pregnant or lactating
• Primary diagnosis of asthma
• Alpha-1 antitrypsin deficiency as the cause of COPD
• Active pulmonary diseases
• Prior lung volume reduction surgery
• Abnormal chest X-ray not due to the presence of COPD
• Hospitalized due to poorly controlled COPD within 3 months of Screening
• Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
• Cancer that has not been in complete remission for at least 5 years
• Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (19)

Pearl Investigative Site

Glendale, Arizona, United States

Location

Pearl Investigative Site

Rancho Mirage, California, United States

Location

Pearl Investigative Site

Waterbury, Connecticut, United States

Location

Pearl Investigative Site

Clearwater, Florida, 33765, United States

Location

Pearl Investigative Site

Clearwater, Florida, United States

Location

Pearl Investigative Site

Pensacola, Florida, United States

Location

Pearl Investigative Site

Winter Park, Florida, 32789, United States

Location

Pearl Investigative Site

Lafayette, Louisiana, United States

Location

Pearl Investigative Site

North Dartmouth, Massachusetts, United States

Location

Pearl Investigative Site

Fridley, Minnesota, United States

Location

Pearl Investigative Site

St Louis, Missouri, United States

Location

Pearl Investigative Site

Summit, New Jersey, United States

Location

Pearl Investigative Site

Cincinnati, Ohio, United States

Location

Pearl Investigative Site

Medford, Oregon, 97504, United States

Location

Pearl Investigative Site

Medford, Oregon, United States

Location

Pearl Investigative Site

Rock Hill, South Carolina, United States

Location

Pearl Investigative Site

Spartanburg, South Carolina, 29303, United States

Location

Pearl Investigative Site

San Antonio, Texas, United States

Location

Pearl Investigative Site

Morgantown, West Virginia, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

creisner@pearltherapeutics.com

973-975-0320

Study Officials

• Colin Reisner, MD

  Pearl Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: April 27, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 30, 2016
• Results First Posted: June 30, 2016

Record last verified: 2016-05

Locations

US (19)