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PT003 MDI Dose Confirmation Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01349816
First Posted: May 9, 2011
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
  Purpose
The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Chronic Dosing (7 Days), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls

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

Primary Outcome Measures:
  • FEV1 AUC0-12 [ Time Frame: Day 7 ]
    Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).


Secondary Outcome Measures:
  • Peak Change From Baseline in FEV1 [ Time Frame: Day 1 ]
    Peak change from baseline in FEV1 through 2 hours

  • Time to Onset of Action [ Time Frame: Day 1 ]
    At least 10% improvement in mean FEV1

  • At Least 12% Improvement in FEV1 [ Time Frame: Day 1 ]
    Proportion of subjects achieving >=12% improvement in FEV1 relative to baseline

  • Peak Change in IC [ Time Frame: Day 1 ]
    Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline

  • Morning Pre-dose FEV1 [ Time Frame: Day 7 ]
    Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7)

  • FEV1 Through 6 Hours [ Time Frame: Day 7 ]
    Peak change from baseline in FEV1 through 6 hours

  • Peak Change From Baseline in IC [ Time Frame: Day 7 ]
    Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline)

  • Mean Evening Trough FEV1 [ Time Frame: Day 7 ]
    Change from baseline in mean evening 12-hour post-dose trough FEV1


Enrollment: 185
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (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: 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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 (or CT scan) 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
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): NCT01349816


Locations
United States, California
Pearl Investigative Site
Rancho Mirage, California, United States
United States, Colorado
Pearl Investigative Site
Colorado Springs, Colorado, 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
Pensacola, Florida, United States
United States, Georgia
Pearl Investigative Site
Stockbridge, Georgia, United States
United States, Minnesota
Pearl Investigative Site
Minneapolis, Minnesota, United States
United States, New York
Pearl Investigative Site
Brooklyn, New York, United States
United States, North Carolina
Pearl Investigative Site
Charlotte, North Carolina, United States
Pearl Investigative Site
Winston-Salem, North Carolina, United States
United States, Ohio
Pearl Investigative Site
Cincinnati, Ohio, United States
United States, Oregon
Pearl Investigative Site
Medford, Oregon, United States
United States, South Carolina
Pearl Investigative Site
Spartanburg, South Carolina, United States
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Study Director: Colin Reisner, M.D. Pearl Therapeutics, Inc.
  More Information

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01349816     History of Changes
Other Study ID Numbers: PT003004
First Submitted: May 5, 2011
First Posted: May 9, 2011
Results First Submitted: May 21, 2016
Results First Posted: April 27, 2017
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Pearl Therapeutics, Inc.:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases


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