PT003 MDI Dose Confirmation Study
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
1 other identifier
interventional
185
1 country
13
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 chronic-obstructive-pulmonary-disease
Started Jun 2011
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2011
CompletedFirst Posted
Study publicly available on registry
May 9, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
April 27, 2017
CompletedApril 27, 2017
April 1, 2017
5 months
May 5, 2011
May 21, 2016
April 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FEV1 AUC0-12
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).
Day 7
Secondary Outcomes (8)
Peak Change From Baseline in FEV1
Day 1
Time to Onset of Action
Day 1
At Least 12% Improvement in FEV1
Day 1
Peak Change in IC
Day 1
Morning Pre-dose FEV1
Day 7
- +3 more secondary outcomes
Study Arms (6)
PT003 (Dose 1)
EXPERIMENTALPT003 MDI Dose 1
PT003 (Dose 2)
EXPERIMENTALPT003 MDI Dose 2
PT003 (Dose 3)
EXPERIMENTALPT003 MDI Dose 3
PT003 (Dose 4)
EXPERIMENTALPT003 MDI Dose 4
PT001
EXPERIMENTALPT001 MDI
PT005
EXPERIMENTALPT005 MDI
Interventions
Eligibility Criteria
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 (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Pearl Investigative Site
Rancho Mirage, California, United States
Pearl Investigative Site
Colorado Springs, Colorado, United States
Pearl Investigative Site
Waterbury, Connecticut, United States
Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Pensacola, Florida, United States
Pearl Investigative Site
Stockbridge, Georgia, United States
Pearl Investigative Site
Minneapolis, Minnesota, United States
Pearl Investigative Site
Brooklyn, New York, United States
Pearl Investigative Site
Charlotte, North Carolina, United States
Pearl Investigative Site
Winston-Salem, North Carolina, United States
Pearl Investigative Site
Cincinnati, Ohio, United States
Pearl Investigative Site
Medford, Oregon, United States
Pearl Investigative Site
Spartanburg, South Carolina, United States
Related Publications (1)
Reisner C, Pearle J, Kerwin EM, Rose ES, Darken P. Efficacy and safety of four doses of glycopyrrolate/formoterol fumarate delivered via a metered dose inhaler compared with the monocomponents in patients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2018 Jun 19;13:1965-1977. doi: 10.2147/COPD.S166455. eCollection 2018.
PMID: 29950826DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Colin Reisner, MD, FCCP, FAAAAI
- Organization
- Pearl Therapeutics, Inc
Study Officials
- STUDY DIRECTOR
Colin Reisner, M.D.
Pearl Therapeutics, Inc.
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
May 5, 2011
First Posted
May 9, 2011
Study Start
June 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
April 27, 2017
Results First Posted
April 27, 2017
Record last verified: 2017-04