PT003 MDI Cardiovascular Safety Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01349803
First received: May 5, 2011
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: PT005 MDI
Drug: PT001 MDI
Drug: PT003 MDI
Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in Mean Heart Rate Average Over 24 Hours Post-dose [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    The primary safety objective of this study is 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).


Secondary Outcome Measures:
  • Characterization of additional cardiovascular safety parameters [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    The secondary objective of the study is to further characterize additional cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).


Enrollment: 237
Study Start Date: May 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PT005 MDI
PT005 MDI
Drug: PT005 MDI
PT005 MDI administered as two puffs BID for 14 days
Experimental: PT001 MDI
PT001 MDI
Drug: PT001 MDI
PT001 MDI administered as two puffs BID for 14 days
Experimental: PT003 MDI
PT003 MDI
Drug: PT003 MDI
PT003 MDI administered as two puffs BID for 14 days
Active Comparator: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days
Other Name: Foradil® Aerolizer®

  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
  • Acceptable baseline (Visit 2) Holter monitor recording

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
  • Clinically significant abnormal findings during the baseline Holter recording
  • Patients with a pacemaker or ICD/CRT/CRT_D devices

Other inclusion/exclusion criteria as defined by 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: NCT01349803

Locations
United States, Arizona
Pearl Investigative Site
Glendale, Arizona, United States
United States, California
Pearl Investigative Site
Fullerton, California, United States
Pearl Investigative Site
Los Angeles, California, United States
Pearl Investigative Site
San Diego, California, United States
United States, Florida
Pearl Investigative Site
Pensacola, Florida, United States
United States, Louisiana
Pearl Investigative Site
Lafayette, Louisiana, United States
United States, Massachusetts
Pearl Investigative Site
North Dartmouth, Massachusetts, United States
United States, Michigan
Pearl Investigative Site
Livonia, Michigan, United States
United States, Oregon
Pearl Investigative Site
Medford, Oregon, United States
United States, Texas
Pearl Investigative Site
San Antonio, Texas, United States
Australia, New South Wales
Pearl Investigative Site
Glebe, New South Wales, Australia
Australia, Queensland
Pearl Investigative Site
Caboolture, Queensland, Australia
Australia, South Australia
Pearl Investigative Site
Dawpark, South Australia, Australia
Pearl Investigative Site
Toorak Gardens, South Australia, Australia
Australia, Victoria
Pearl Investigative Site
Heidelberg, Victoria, Australia
Australia, Western Australia
Pearl Investigative Site
Nedlands, Western Australia, Australia
New Zealand
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, New Zealand
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Study Director: Colin Reisner, M.D. Pearl Therapeutics
  More Information

No publications provided

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01349803     History of Changes
Other Study ID Numbers: PT003003
Study First Received: May 5, 2011
Last Updated: May 23, 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
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

ClinicalTrials.gov processed this record on August 21, 2014