PT003 MDI Cardiovascular Safety Study

Chronic Obstructive Pulmonary Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349803
• Other study ID #: PT003003
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2011
• Last updated: May 23, 2013
• Start date: May 2011
• Est. completion date: November 2011

Study information

• Verified date: May 2013
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• PT005 MDI
PT005 MDI administered as two puffs BID for 14 days
• PT001 MDI
PT001 MDI administered as two puffs BID for 14 days
• PT003 MDI
PT003 MDI administered as two puffs BID for 14 days
• Formoterol Fumarate 12 µg (Foradil® Aerolizer®)
Formoterol Fumarate 12 µg (Foradil® Aerolizer®) administered BID for 14 days

Locations

Country	Name	City	State
Australia	Pearl Investigative Site	Caboolture	Queensland
Australia	Pearl Investigative Site	Dawpark	South Australia
Australia	Pearl Investigative Site	Glebe	New South Wales
Australia	Pearl Investigative Site	Heidelberg	Victoria
Australia	Pearl Investigative Site	Nedlands	Western Australia
Australia	Pearl Investigative Site	Toorak Gardens	South Australia
New Zealand	Pearl Investigative Site	Caversham	Dunedin
New Zealand	Pearl Investigative Site	Newtown	Wellington
New Zealand	Pearl Investigative Site	Private Bag	Hamilton
New Zealand	Pearl Investigative Site	Tauranga	North Island
United States	Pearl Investigative Site	Fullerton	California
United States	Pearl Investigative Site	Glendale	Arizona
United States	Pearl Investigative Site	Lafayette	Louisiana
United States	Pearl Investigative Site	Livonia	Michigan
United States	Pearl Investigative Site	Los Angeles	California
United States	Pearl Investigative Site	Medford	Oregon
United States	Pearl Investigative Site	North Dartmouth	Massachusetts
United States	Pearl Investigative Site	Pensacola	Florida
United States	Pearl Investigative Site	San Antonio	Texas
United States	Pearl Investigative Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Heart Rate Average Over 24 Hours Post-dose	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).	14 days	Yes
Secondary	Characterization of additional cardiovascular safety parameters	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).	24 hours	Yes