PT003 MDI Cardiovascular Safety Study
A Randomized, Double-blind, Parallel Group, 14-day, Multi-Center Study to Evaluate the Safety of PT003, PT005, PT001 and Foradil® Aerolizer® (12 µg, Open Label) as Evaluated by Holter Monitoring, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
237
3 countries
20
Brief Summary
This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.
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 May 2011
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
20 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
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 5, 2011
CompletedFirst Posted
Study publicly available on registry
May 9, 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
January 31, 2017
CompletedJanuary 31, 2017
November 1, 2016
6 months
May 5, 2011
May 24, 2016
December 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in 24-Hour Mean Heart Rate Post-dose
The primary safety objective of this study was to compare the change in mean heart rate averaged over 24 hours post-dose, following twice daily dosing over 14 days with PT003 MDI, PT005 MDI, PT001 MDI or Foradil Aerolizer compared to baseline in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
14 days
Secondary Outcomes (15)
Change From Baseline in Mean FEV1 Trough
Day 7 to Day 14
Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment
24 hours
Change From Baseline in Daytime Mean Heart Rate
Baseline, Day 1, and Day 14
Change From Baseline in Night Time Mean Heart Rate
Baseline, Day 1, and Day 14
Change From Baseline in 24-Hour Maximum Heart Rate
Baseline, Day 1, and Day 14
- +10 more secondary outcomes
Study Arms (4)
PT005 MDI
EXPERIMENTALPT005 MDI
PT001 MDI
EXPERIMENTALPT001 MDI
PT003 MDI
EXPERIMENTALPT003 MDI
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
ACTIVE COMPARATORFormoterol Fumarate 12 μg (Foradil® Aerolizer®)
Interventions
Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days
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
- Acceptable baseline (Visit 2) Holter monitor recording
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
- Clinically significant abnormal findings during the baseline Holter recording
- Patients with a pacemaker or ICD/CRT/CRT\_D devices
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Pearl Investigative Site
Glendale, Arizona, United States
Pearl Investigative Site
Fullerton, California, United States
Pearl Investigative Site
Los Angeles, California, United States
Pearl Investigative Site
San Diego, California, United States
Pearl Investigative Site
Pensacola, Florida, United States
Pearl Investigative Site
Lafayette, Louisiana, United States
Pearl Investigative Site
North Dartmouth, Massachusetts, United States
Pearl Investigative Site
Livonia, Michigan, United States
Pearl Investigative Site
Medford, Oregon, United States
Pearl Investigative Site
San Antonio, Texas, United States
Pearl Investigative Site
Glebe, New South Wales, Australia
Pearl Investigative Site
Caboolture, Queensland, Australia
Pearl Investigative Site
Dawpark, South Australia, Australia
Pearl Investigative Site
Toorak Gardens, South Australia, Australia
Pearl Investigative Site
Heidelberg, Victoria, Australia
Pearl Investigative Site
Nedlands, Western Australia, Australia
Pearl Investigative Site
Caversham, Dunedin, New Zealand
Pearl Investigative Site
Private Bag, Hamilton, New Zealand
Pearl Investigative Site
Tauranga, North Island, New Zealand
Pearl Investigative Site
Newtown, Wellington Region, New Zealand
Related Publications (1)
Ferguson GT, Reisner C, Pearle J, DePetrillo P, Maes A, Martin UJ. Cardiovascular safety profile of a fixed-dose combination of glycopyrrolate and formoterol fumarate delivered via metered dose inhaler using co-suspension delivery technology. Pulm Pharmacol Ther. 2018 Apr;49:67-74. doi: 10.1016/j.pupt.2018.01.007. Epub 2018 Feb 4.
PMID: 29567116DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2011
First Posted
May 9, 2011
Study Start
May 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
January 31, 2017
Results First Posted
January 31, 2017
Record last verified: 2016-11