Back to resultsPT003 MDI Cardiovascular Safety Study
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PT005 MDI
PT001 MDI
PT003 MDI
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
Eligibility Criteria
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
Sites / Locations
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
- Pearl Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
PT005 MDI
PT001 MDI
PT003 MDI
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Arm Description
PT005 MDI
PT001 MDI
PT003 MDI
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change From Baseline in Mean FEV1 Trough
Trough FEV1 averaged over Day 7 and Day 14
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01349803
Brief Title
PT003 MDI Cardiovascular Safety Study
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pearl Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
237 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PT005 MDI
Arm Type
Experimental
Arm Description
PT005 MDI
Arm Title
PT001 MDI
Arm Type
Experimental
Arm Description
PT001 MDI
Arm Title
PT003 MDI
Arm Type
Experimental
Arm Description
PT003 MDI
Arm Title
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Arm Type
Active Comparator
Arm Description
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Intervention Type
Drug
Intervention Name(s)
PT005 MDI
Intervention Description
PT005 MDI administered as two puffs BID for 14 days
Intervention Type
Drug
Intervention Name(s)
PT001 MDI
Intervention Description
PT001 MDI administered as two puffs BID for 14 days
Intervention Type
Drug
Intervention Name(s)
PT003 MDI
Intervention Description
PT003 MDI administered as two puffs BID for 14 days
Intervention Type
Drug
Intervention Name(s)
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Other Intervention Name(s)
Foradil® Aerolizer®
Intervention Description
Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days
Primary Outcome Measure Information:
Title
Change From Baseline in 24-Hour Mean Heart Rate Post-dose
Description
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).
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean FEV1 Trough
Description
Trough FEV1 averaged over Day 7 and Day 14
Time Frame
Day 7 to Day 14
Title
Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment
Description
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).
Time Frame
24 hours
Title
Change From Baseline in Daytime Mean Heart Rate
Description
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).
Time Frame
Baseline, Day 1, and Day 14
Title
Change From Baseline in Night Time Mean Heart Rate
Description
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).
Time Frame
Baseline, Day 1, and Day 14
Title
Change From Baseline in 24-Hour Maximum Heart Rate
Description
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).
Time Frame
Baseline, Day 1, and Day 14
Title
Change From Baseline in 24-Hour Minimum Heart Rate
Description
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).
Time Frame
Baseline, Day 1, and Day 14
Title
Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring
Description
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).
Time Frame
Baseline, Day 1, and Day 14
Title
Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring
Description
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).
Time Frame
Baseline, Day 1, and Day 14
Title
Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring
Description
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).
Time Frame
Baseline, Day 1, and Day 14
Title
Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring
Description
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).
Time Frame
Baseline, Day 1, and Day 14
Title
Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring
Description
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).
Time Frame
Baseline, Day 1, and Day 14
Title
Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring
Description
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).
Time Frame
Baseline, Day 1, and Day 14
Title
Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring
Description
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).
Time Frame
Baseline, Day 1, and Day 14
Title
Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring
Description
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).
Time Frame
Baseline, Day 1, and Day 14
Title
Mean Change From Baseline in QTcF Interval
Description
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).
Time Frame
Baseline, Day 1, Day 7, and Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Reisner, M.D.
Organizational Affiliation
Pearl Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Pearl Investigative Site
City
Glendale
State/Province
Arizona
Country
United States
Facility Name
Pearl Investigative Site
City
Fullerton
State/Province
California
Country
United States
Facility Name
Pearl Investigative Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Pearl Investigative Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Pearl Investigative Site
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
Pearl Investigative Site
City
Lafayette
State/Province
Louisiana
Country
United States
Facility Name
Pearl Investigative Site
City
North Dartmouth
State/Province
Massachusetts
Country
United States
Facility Name
Pearl Investigative Site
City
Livonia
State/Province
Michigan
Country
United States
Facility Name
Pearl Investigative Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Pearl Investigative Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pearl Investigative Site
City
Glebe
State/Province
New South Wales
Country
Australia
Facility Name
Pearl Investigative Site
City
Caboolture
State/Province
Queensland
Country
Australia
Facility Name
Pearl Investigative Site
City
Dawpark
State/Province
South Australia
Country
Australia
Facility Name
Pearl Investigative Site
City
Toorak Gardens
State/Province
South Australia
Country
Australia
Facility Name
Pearl Investigative Site
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Pearl Investigative Site
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Pearl Investigative Site
City
Caversham
State/Province
Dunedin
Country
New Zealand
Facility Name
Pearl Investigative Site
City
Private Bag
State/Province
Hamilton
Country
New Zealand
Facility Name
Pearl Investigative Site
City
Tauranga
State/Province
North Island
Country
New Zealand
Facility Name
Pearl Investigative Site
City
Newtown
State/Province
Wellington
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
29567116
Citation
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.
Results Reference
derived
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PT003 MDI Cardiovascular Safety Study
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