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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Change From Baseline in Mean FEV1 Trough
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
Timepoint [2] 0 0
24 hours
Secondary outcome [3] 0 0
Change From Baseline in Daytime Mean Heart Rate
Timepoint [3] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [4] 0 0
Change From Baseline in Night Time Mean Heart Rate
Timepoint [4] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [5] 0 0
Change From Baseline in 24-Hour Maximum Heart Rate
Timepoint [5] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [6] 0 0
Change From Baseline in 24-Hour Minimum Heart Rate
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
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
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
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
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
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
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
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
Timepoint [14] 0 0
Baseline, Day 1, and Day 14
Secondary outcome [15] 0 0
Mean Change From Baseline in QTcF Interval
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
Sex
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
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
Sample size
Target
Accrual to date
Final
237
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/ct2/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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT01349803