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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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)
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Secondary ID [1]
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PT003003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in 24-Hour Mean Heart Rate Post-dose
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Assessment method [1]
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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).
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Timepoint [1]
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14 days
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Secondary outcome [1]
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Change From Baseline in Mean FEV1 Trough
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Assessment method [1]
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Trough FEV1 averaged over Day 7 and Day 14
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Timepoint [1]
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Day 7 to Day 14
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Secondary outcome [2]
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Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment
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Assessment method [2]
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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).
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Timepoint [2]
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24 hours
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Secondary outcome [3]
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Change From Baseline in Daytime Mean Heart Rate
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Assessment method [3]
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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).
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Timepoint [3]
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Baseline, Day 1, and Day 14
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Secondary outcome [4]
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Change From Baseline in Night Time Mean Heart Rate
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Assessment method [4]
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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).
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Timepoint [4]
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Baseline, Day 1, and Day 14
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Secondary outcome [5]
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Change From Baseline in 24-Hour Maximum Heart Rate
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Assessment method [5]
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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).
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Timepoint [5]
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Baseline, Day 1, and Day 14
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Secondary outcome [6]
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Change From Baseline in 24-Hour Minimum Heart Rate
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Assessment method [6]
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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).
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Timepoint [6]
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Baseline, Day 1, and Day 14
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Secondary outcome [7]
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Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring
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Assessment method [7]
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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).
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Timepoint [7]
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Baseline, Day 1, and Day 14
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Secondary outcome [8]
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Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring
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Assessment method [8]
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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).
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Timepoint [8]
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Baseline, Day 1, and Day 14
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Secondary outcome [9]
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Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring
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Assessment method [9]
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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).
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Timepoint [9]
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Baseline, Day 1, and Day 14
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Secondary outcome [10]
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Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring
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Assessment method [10]
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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).
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Timepoint [10]
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Baseline, Day 1, and Day 14
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Secondary outcome [11]
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Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring
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Assessment method [11]
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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).
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Timepoint [11]
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Baseline, Day 1, and Day 14
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Secondary outcome [12]
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Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring
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Assessment method [12]
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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).
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Timepoint [12]
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Baseline, Day 1, and Day 14
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Secondary outcome [13]
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Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring
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Assessment method [13]
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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).
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Timepoint [13]
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Baseline, Day 1, and Day 14
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Secondary outcome [14]
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Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring
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Assessment method [14]
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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).
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Timepoint [14]
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Baseline, Day 1, and Day 14
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Secondary outcome [15]
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Mean Change From Baseline in QTcF Interval
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Assessment method [15]
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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).
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Timepoint [15]
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Baseline, Day 1, Day 7, and Day 14
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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
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Minimum age
40
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2011
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Sample size
Target
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Accrual to date
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Final
237
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Pearl Investigative Site - Glebe
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Recruitment hospital [2]
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Pearl Investigative Site - Caboolture
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Recruitment hospital [3]
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Pearl Investigative Site - Dawpark
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Recruitment hospital [4]
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Pearl Investigative Site - Toorak Gardens
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Recruitment hospital [5]
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Pearl Investigative Site - Heidelberg
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Recruitment hospital [6]
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Pearl Investigative Site - Nedlands
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Recruitment postcode(s) [1]
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- Glebe
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Recruitment postcode(s) [2]
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- Caboolture
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Recruitment postcode(s) [3]
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- Dawpark
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Recruitment postcode(s) [4]
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- Toorak Gardens
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Recruitment postcode(s) [5]
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- Heidelberg
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Recruitment postcode(s) [6]
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- Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Louisiana
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Michigan
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Country [7]
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United States of America
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State/province [7]
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Oregon
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Country [8]
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United States of America
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State/province [8]
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Texas
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Country [9]
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New Zealand
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State/province [9]
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Dunedin
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Country [10]
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New Zealand
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State/province [10]
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Hamilton
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Country [11]
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New Zealand
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State/province [11]
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North Island
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Country [12]
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New Zealand
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State/province [12]
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pearl Therapeutics, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01349803
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Trial related presentations / publications
Ferguson GT, Reisner C, Pearle J, DePetrillo P, Maes A, Martin UJ. Cardiovascular safety profile of a fixed-dose combination of glycopyrrolate and formoterol fumarate delivered via metered dose inhaler using co-suspension delivery technology. Pulm Pharmacol Ther. 2018 Apr;49:67-74. doi: 10.1016/j.pupt.2018.01.007. Epub 2018 Feb 4.
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Public notes
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Contacts
Principal investigator
Name
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Colin Reisner, M.D.
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Address
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Pearl Therapeutics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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/study/NCT01349803
Download to PDF