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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01587079
First received: April 25, 2012
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: PT003
Drug: PT001
Drug: PT005
Drug: Tiotropium inhalation powder
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control

Resource links provided by NLM:


Further study details as provided by Pearl Therapeutics, Inc.:

Primary Outcome Measures:
  • FEV1 AUC0-12 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    FEV1 AUC0-12 relative to baseline following chronic dosing (1 week).


Enrollment: 159
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PT003 (Dose 1)
PT003 MDI Dose 1
Drug: PT003
PT003 MDI administered as two puffs BID for 7 days
Experimental: PT003 (Dose 2)
PT003 MDI Dose 2
Drug: PT003
PT003 MDI administered as two puffs BID for 7 days
Experimental: PT003 (Dose 3)
PT003 MDI Dose 3
Drug: PT003
PT003 MDI administered as two puffs BID for 7 days
Experimental: PT003 (Dose 4)
PT003 MDI Dose 4
Drug: PT003
PT003 MDI administered as two puffs BID for 7 days
Experimental: PT003 (Dose 5)
PT003 MDI Dose 5
Drug: PT003
PT003 MDI administered as two puffs BID for 7 days
Experimental: PT001
PT001 MDI
Drug: PT001
PT001 MDI administered as two puffs BID for 7 days
Experimental: PT005
PT005 MDI
Drug: PT005
PT005 MDI administered as two puffs BID for 7 days
Active Comparator: Spiriva® Handihaler®
Tiotropium Bromide
Drug: Tiotropium inhalation powder
Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Signed written informed consent
  • 40 - 80 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

Key Exclusion Criteria:

  • 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

Other inclusion/exclusion criteria as defined in the protocol

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01587079

Locations
United States, Arizona
Pearl Investigative Site
Glendale, Arizona, United States
United States, California
Pearl Investigative Site
Rancho Mirage, California, United States
United States, Connecticut
Pearl Investigative Site
Waterbury, Connecticut, United States
United States, Florida
Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Clearwater, Florida, United States, 33765
Pearl Investigative Site
Pensacola, Florida, United States
Pearl Investigative Site
Winter Park, Florida, United States, 32789
United States, Louisiana
Pearl Investigative Site
Lafayette, Louisiana, United States
United States, Massachusetts
Pearl Investigative Site
North Dartmouth, Massachusetts, United States
United States, Minnesota
Pearl Investigative Site
Fridley, Minnesota, United States
United States, Missouri
Pearl Investigative Site
St. Louis, Missouri, United States
United States, New Jersey
Pearl Investigative Site
Summit, New Jersey, United States
United States, Ohio
Pearl Investigative Site
Cincinnati, Ohio, United States
United States, Oregon
Pearl Investigative Site
Medford, Oregon, United States, 97504
Pearl Investigative Site
Medford, Oregon, United States
United States, South Carolina
Pearl Investigative Site
Rock Hill, South Carolina, United States
Pearl Investigative Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
Pearl Investigative Site
San Antonio, Texas, United States
United States, West Virginia
Pearl Investigative Site
Morgantown, West Virginia, United States
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Study Director: Colin Reisner, MD Pearl Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01587079     History of Changes
Other Study ID Numbers: PT003005
Study First Received: April 25, 2012
Last Updated: October 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pearl Therapeutics, Inc.:
COPD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Formoterol
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on August 27, 2014