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Completed

NCT Number: NCT01349803

PT003 MDI Cardiovascular Safety Study

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pearl Investigative Site, Glebe, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PT005 MDI

Drug

PT005 MDI administered as two puffs BID for 14 days

PT001 MDI

Drug

PT001 MDI administered as two puffs BID for 14 days

PT003 MDI

Drug

PT003 MDI administered as two puffs BID for 14 days

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Drug

Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days

Other names: Foradil® Aerolizer®

Primary outcomes

  1. Change From Baseline in 24-Hour Mean Heart Rate Post-dose

    Time frame: 14 days

    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).

Secondary outcomes

  1. Change From Baseline in Mean FEV1 Trough

    Time frame: Day 7 to Day 14

    Trough FEV1 averaged over Day 7 and Day 14

  2. Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment

    Time frame: 24 hours

    The secondary objectives of the study was to further characterize 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).

  3. Change From Baseline in Daytime Mean Heart Rate

    Time frame: Baseline, Day 1, and Day 14

    The secondary objectives of the study was to further characterize 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).

  4. Change From Baseline in Night Time Mean Heart Rate

    Time frame: Baseline, Day 1, and Day 14

    The secondary objectives of the study was to further characterize 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).

  5. Change From Baseline in 24-Hour Maximum Heart Rate

    Time frame: Baseline, Day 1, and Day 14

    The secondary objectives of the study was to further characterize 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).

  6. Change From Baseline in 24-Hour Minimum Heart Rate

    Time frame: Baseline, Day 1, and Day 14

    The secondary objectives of the study was to further characterize 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).

  7. Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring

    Time frame: Baseline, Day 1, and Day 14

    The secondary objectives of the study was to further characterize 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).

  8. Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring

    Time frame: Baseline, Day 1, and Day 14

    The secondary objectives of the study was to further characterize 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).

  9. Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring

    Time frame: Baseline, Day 1, and Day 14

    The secondary objectives of the study was to further characterize 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).

  10. Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring

    Time frame: Baseline, Day 1, and Day 14

    The secondary objectives of the study was to further characterize 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).

  11. Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring

    Time frame: Baseline, Day 1, and Day 14

    The secondary objectives of the study was to further characterize 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).

  12. Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring

    Time frame: Baseline, Day 1, and Day 14

    The secondary objectives of the study was to further characterize 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).

  13. Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring

    Time frame: Baseline, Day 1, and Day 14

    The secondary objectives of the study was to further characterize 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).

  14. Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring

    Time frame: Baseline, Day 1, and Day 14

    The secondary objectives of the study was to further characterize 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).

  15. Mean Change From Baseline in QTcF Interval

    Time frame: Baseline, Day 1, Day 7, and Day 14

    The secondary objectives of the study was to further characterize 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).

Sponsors and collaborators

Lead sponsor

Pearl Therapeutics, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 9, 2011
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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