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

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ClinicalTrials.gov Identifier: NCT01587079
Recruitment Status : Completed
First Posted : April 27, 2012
Results First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. FEV1 AUC 0-12 on Day 7 [ Time Frame: Day 7 ]
    FEV1 AUC 0-12


Secondary Outcome Measures :
  1. Peak Change From Baseline in FEV1 on Treatment Day 1 [ Time Frame: Day 1 ]
    Peak change from Baseline in FEV1 on Treatment

  2. Time to Onset of Action (>10% Improvement in FEV1) on Day 1 [ Time Frame: Day 1 ]
    Time to onset of action (>10% improvement in FEV1)

  3. Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1 [ Time Frame: Day 1 ]
    Proportion of subjects achieving >=12% improvement in FEV1

  4. Peak Change From Baseline in Inspiratory Capacity on Day 1 [ Time Frame: Day 1 ]
    Peak change from baseline in Inspiratory Capacity

  5. Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7 [ Time Frame: Day 7 ]
    Change from baseline in morning pre-dose trough FEV1

  6. Peak Change From Baseline in FEV1 on Day 7 [ Time Frame: Day 7 ]
    Peak change from baseline in FEV1 Day 7

  7. Change From Baseline in Morning Pre-dose Trough IC on Day 7 [ Time Frame: Day 7 ]
    Change from baseline in morning pre-dose trough IC

  8. Peak Change From Baseline IC on Day 7 [ Time Frame: Day 7 ]
    Peak change from baseline IC

  9. Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7 [ Time Frame: Day 7 ]
    Change from baseline at evening 12-hour post-dose trough FEV1

  10. Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7 [ Time Frame: Day 7 ]
    Change from baseline in mean morning pre-dose daily peak flow readings

  11. Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7 [ Time Frame: Day 7 ]
    Change from baseline in mean morning post-dose daily peak flow readings on

  12. Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7 [ Time Frame: Day 7 ]
    Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)

  13. Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7 [ Time Frame: Day 7 ]
    Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 33765
Pearl Investigative Site
Clearwater, Florida, United States
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.

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01587079     History of Changes
Other Study ID Numbers: PT003005
First Posted: April 27, 2012    Key Record Dates
Results First Posted: June 30, 2016
Last Update Posted: June 30, 2016
Last Verified: May 2016

Keywords provided by Pearl Therapeutics, Inc.:
COPD

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