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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01349803




Registration number
NCT01349803
Ethics application status
Date submitted
5/05/2011
Date registered
9/05/2011
Date last updated
31/01/2017

Titles & IDs
Public title
PT003 MDI Cardiovascular Safety Study
Scientific 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)
Secondary ID [1] 0 0
PT003003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PT005 MDI
Treatment: Drugs - PT001 MDI
Treatment: Drugs - PT003 MDI
Treatment: Drugs - Formoterol Fumarate 12 µg (Foradil® Aerolizer®)

Experimental: PT005 MDI - PT005 MDI

Experimental: PT001 MDI - PT001 MDI

Experimental: PT003 MDI - PT003 MDI

Active Comparator: Formoterol Fumarate 12 µg (Foradil® Aerolizer®) - Formoterol Fumarate 12 µg (Foradil® Aerolizer®)


Treatment: Drugs: PT005 MDI
PT005 MDI administered as two puffs BID for 14 days

Treatment: Drugs: PT001 MDI
PT001 MDI administered as two puffs BID for 14 days

Treatment: Drugs: PT003 MDI
PT003 MDI administered as two puffs BID for 14 days

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Change From Baseline in Mean FEV1 Trough - Trough FEV1 averaged over Day 7 and Day 14
Timepoint [1] 0 0
Day 7 to Day 14
Secondary outcome [2] 0 0
Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment - 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).
Timepoint [2] 0 0
24 hours
Secondary outcome [3] 0 0
Change From Baseline in Daytime Mean Heart Rate - 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).
Timepoint [3] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [4] 0 0
Change From Baseline in Night Time Mean Heart Rate - 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).
Timepoint [4] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [5] 0 0
Change From Baseline in 24-Hour Maximum Heart Rate - 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).
Timepoint [5] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [6] 0 0
Change From Baseline in 24-Hour Minimum Heart Rate - 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).
Timepoint [6] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [7] 0 0
Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring - 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).
Timepoint [7] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [8] 0 0
Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring - 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).
Timepoint [8] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [9] 0 0
Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring - 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).
Timepoint [9] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [10] 0 0
Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring - 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).
Timepoint [10] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [11] 0 0
Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring - 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).
Timepoint [11] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [12] 0 0
Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring - 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).
Timepoint [12] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [13] 0 0
Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring - 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).
Timepoint [13] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [14] 0 0
Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring - 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).
Timepoint [14] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [15] 0 0
Mean Change From Baseline in QTcF Interval - 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).
Timepoint [15] 0 0
Baseline, Day 1, Day 7, and Day 14

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pearl Investigative Site - Glebe
Recruitment hospital [2] 0 0
Pearl Investigative Site - Caboolture
Recruitment hospital [3] 0 0
Pearl Investigative Site - Dawpark
Recruitment hospital [4] 0 0
Pearl Investigative Site - Toorak Gardens
Recruitment hospital [5] 0 0
Pearl Investigative Site - Heidelberg
Recruitment hospital [6] 0 0
Pearl Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Glebe
Recruitment postcode(s) [2] 0 0
- Caboolture
Recruitment postcode(s) [3] 0 0
- Dawpark
Recruitment postcode(s) [4] 0 0
- Toorak Gardens
Recruitment postcode(s) [5] 0 0
- Heidelberg
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
New Zealand
State/province [9] 0 0
Dunedin
Country [10] 0 0
New Zealand
State/province [10] 0 0
Hamilton
Country [11] 0 0
New Zealand
State/province [11] 0 0
North Island
Country [12] 0 0
New Zealand
State/province [12] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pearl Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01349803
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colin Reisner, M.D.
Address 0 0
Pearl Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications