PT003 MDI Dose Confirmation Study | NCT01349816 | Trialant
NCT01349816
Sponsor
Pearl Therapeutics, Inc.
Status
Completed
Last Update Posted
Apr 27, 2017Actual
Enrollment
185Actual
Phase
Phase 2
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
PT003
PT001
PT005
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01349816
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PT003004
Secondary IDs
Not provided
Brief Title
PT003 MDI Dose Confirmation Study
Official Title
A Randomized, Double Blind, Chronic Dosing (7 Days), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls
Acronym
Not provided
Organization
Pearl Therapeutics, Inc.INDUSTRY
Status Module
Record Verification Date
Apr 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2011
Primary Completion Date
Nov 2011Actual
Completion Date
Nov 2011Actual
First Submitted Date
May 5, 2011
First Submission Date that Met QC Criteria
May 6, 2011
First Posted Date
May 9, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
May 21, 2016
Results First Submitted that Met QC Criteria
Apr 26, 2017
Results First Posted Date
Apr 27, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
May 16, 2013
Certification/Extension First Submitted that Passed QC Review
May 16, 2013
Certification/Extension First Posted Date
May 24, 2013Estimated
Last Update Submitted Date
Apr 26, 2017
Last Update Posted Date
Apr 27, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Pearl Therapeutics, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Obstructive Pulmonary Disease
Keywords
COPD
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
185Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PT003 (Dose 1)
Experimental
PT003 MDI Dose 1
Drug: PT003
PT003 (Dose 2)
Experimental
PT003 MDI Dose 2
Drug: PT003
PT003 (Dose 3)
Experimental
PT003 MDI Dose 3
Drug: PT003
PT003 (Dose 4)
Experimental
PT003 MDI Dose 4
Drug: PT003
PT001
Experimental
PT001 MDI
Drug: PT001
PT005
Experimental
PT005 MDI
Drug: PT005
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PT003
Drug
PT003 MDI administered as two puffs BID for 7 days
PT003 (Dose 1)
PT003 (Dose 2)
PT003 (Dose 3)
PT003 (Dose 4)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
FEV1 AUC0-12
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).
Day 7
Secondary Outcomes
Measure
Description
Time Frame
Peak Change From Baseline in FEV1
Peak change from baseline in FEV1 through 2 hours
Day 1
Time to Onset of Action
At least 10% improvement in mean FEV1
Other Outcomes
Not provided
Eligibility Module
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
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
Other inclusion/exclusion criteria as defined in the protocol
Reisner C, Pearle J, Kerwin EM, Rose ES, Darken P. Efficacy and safety of four doses of glycopyrrolate/formoterol fumarate delivered via a metered dose inhaler compared with the monocomponents in patients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2018 Jun 19;13:1965-1977. doi: 10.2147/COPD.S166455. eCollection 2018.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Study was a chronic dosing study; each participant received 2 of 6 possible treatments; each treatment period was separated by a washout period of at least 7 days. Patients were randomized into one of 30 treatment sequences. Each sequence included exactly 2 of the 6 treatment groups for this study.
Recruitment Details
Conducted at 14 US sites from July-November 2011. Entire study period of study participation was a maximum of 9 weeks.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Overall Study
Overall Study
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG000185 subjects
GP MDI 36 µg
FG00061 subjects
GFF MDI 36/7.2 µg
FG00058 subjects
GFF MDI 36/9.6 µg
FG00056 subjects
GFF MDI 18/9.6 µg
FG00057 subjects
GFF MDI 9/9.6 µg
FG00057 subjects
FF MDI 9.6 µg
FG00061 subjects
COMPLETED
FG000155 subjects
NOT COMPLETED
FG00030 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0004 subjects
Physician Decision
FG0001 subjects
Adverse Event
FG00014 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
Analysis population included all randomized subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Overall Study
All patients randomized and treated
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
FEV1 AUC0-12
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).
Modified Intent to Treat (MITT) Population is made of participants who completed both treatment periods and had Pre-dose Day 1 data for both and no protocol deviations believed to have a potential impact on efficacy results. Subjects must have had data for the given endpoint to be included.
Posted
Least Squares Mean
95% Confidence Interval
Liters
Day 7
ID
Title
Description
OG000
GFF MDI 36/7.2 µg
GFF MDI 36/7.2 µg BID
OG001
GFF MDI 36/9.6 µg
GFF MDI 36/9.6 µg BID
Adverse Events Module
Frequency Threshold
5
Time Frame
Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Description
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
PT001 MDI administered as two puffs BID for 7 days
PT001
PT005
Drug
PT005 MDI administered as two puffs BID for 7 days
PT005
Day 1
At Least 12% Improvement in FEV1
Proportion of subjects achieving >=12% improvement in FEV1 relative to baseline
Day 1
Peak Change in IC
Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline
Day 1
Morning Pre-dose FEV1
Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7)
Day 7
FEV1 Through 6 Hours
Peak change from baseline in FEV1 through 6 hours
Day 7
Peak Change From Baseline in IC
Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline)
Day 7
Mean Evening Trough FEV1
Change from baseline in mean evening 12-hour post-dose trough FEV1
Day 7
Colorado Springs
Colorado
United States
Pearl Investigative Site
Waterbury
Connecticut
United States
Pearl Investigative Site
Clearwater
Florida
United States
Pearl Investigative Site
Pensacola
Florida
United States
Pearl Investigative Site
Stockbridge
Georgia
United States
Pearl Investigative Site
Minneapolis
Minnesota
United States
Pearl Investigative Site
Brooklyn
New York
United States
Pearl Investigative Site
Charlotte
North Carolina
United States
Pearl Investigative Site
Winston-Salem
North Carolina
United States
Pearl Investigative Site
Cincinnati
Ohio
United States
Pearl Investigative Site
Medford
Oregon
United States
Pearl Investigative Site
Spartanburg
South Carolina
United States
Lost to Follow-up
FG0002 subjects
Protocol Violation
FG0001 subjects
Protocol-specified criteria
FG0008 subjects
185
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00062.1± 9.18
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00078
Male
BG000107
OG002
GFF MDI 18/9.6 µg
GFF MDI 18/9.6 µg BID
OG003
GFF MDI 9/9.6 µg
GFF MDI 9/9.6 µg BID
OG004
GP MDI 36 µg
GP MDI 36 µg BID
OG005
FF MDI 9.6 µg
FF MDI 9.6 µg BID
Units
Counts
Participants
OG00049
OG00142
OG00244
OG00350
OG00449
OG00550
Title
Denominators
Categories
Title
Measurements
OG0001.467(1.424 to 1.511)
OG0011.462(1.418 to 1.508)
OG0021.493(1.448 to 1.539)
OG0031.499(1.455 to 1.544)
OG0041.399(1.358 to 1.441)
OG0051.465(1.423 to 1.509)
Secondary
Peak Change From Baseline in FEV1
Peak change from baseline in FEV1 through 2 hours
MITT Population
Posted
Least Squares Mean
95% Confidence Interval
Liters
Day 1
ID
Title
Description
OG000
GFF MDI 36/7.2 µg
GFF MDI 36/7.2 µg BID
OG001
GFF MDI 36/9.6 µg
GFF MDI 36/9.6 µg BID
OG002
GFF MDI 18/9.6 µg
GFF MDI 18/9.6 µg BID
OG003
GFF MDI 9/9.6 µg
GFF MDI 9/9.6 µg BID
OG004
GP MDI 36 µg
GP MDI 36 µg BID
OG005
FF MDI 9.6 µg
FF MDI 9.6 µg BID
Units
Counts
Participants
OG00049
OG00143
OG00245
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.312(0.265 to 0.359)
OG0010.308(0.259 to 0.358)
OG0020.344(0.295 to 0.393)
OG003
Secondary
Time to Onset of Action
At least 10% improvement in mean FEV1
MITT Population
Posted
Number
Participants
Day 1
ID
Title
Description
OG000
GFF MDI 36/7.2 µg
GFF MDI 36/7.2 µg BID
OG001
GFF MDI 36/9.6 µg
GFF MDI 36/9.6 µg BID
OG002
GFF MDI 18/9.6 µg
GFF MDI 18/9.6 µg BID
OG003
GFF MDI 9/9.6 µg
GFF MDI 9/9.6 µg BID
OG004
GP MDI 36 µg
GP MDI 36 µg BID
OG005
FF MDI 9.6 µg
FF MDI 9.6 µg BID
Units
Counts
Participants
OG00050
OG00143
OG00245
OG003
Title
Denominators
Categories
15 minutes
Title
Measurements
OG00028(0.265 to 0.359)
OG00121(0.259 to 0.358)
OG00220(0.295 to 0.393)
OG003
Secondary
At Least 12% Improvement in FEV1
Proportion of subjects achieving >=12% improvement in FEV1 relative to baseline
MITT Population
Posted
Number
Participants
Day 1
ID
Title
Description
OG000
GFF MDI 36/7.2 µg
GFF MDI 36/7.2 µg BID
OG001
GFF MDI 36/9.6 µg
GFF MDI 36/9.6 µg BID
OG002
GFF MDI 18/9.6 µg
GFF MDI 18/9.6 µg BID
OG003
GFF MDI 9/9.6 µg
GFF MDI 9/9.6 µg BID
OG004
GP MDI 36 µg
GP MDI 36 µg BID
OG005
FF MDI 9.6 µg
FF MDI 9.6 µg BID
Units
Counts
Participants
OG00050
OG00143
OG00245
OG003
Title
Denominators
Categories
15 minutes
Title
Measurements
OG00022(0.265 to 0.359)
OG00117(0.259 to 0.358)
OG00218(0.295 to 0.393)
OG003
Secondary
Peak Change in IC
Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline
MITT Population
Posted
Least Squares Mean
95% Confidence Interval
Liters
Day 1
ID
Title
Description
OG000
GFF MDI 36/7.2 µg
GFF MDI 36/7.2 µg BID
OG001
GFF MDI 36/9.6 µg
GFF MDI 36/9.6 µg BID
OG002
GFF MDI 18/9.6 µg
GFF MDI 18/9.6 µg BID
OG003
GFF MDI 9/9.6 µg
GFF MDI 9/9.6 µg BID
OG004
GP MDI 36 µg
GP MDI 36 µg BID
OG005
FF MDI 9.6 µg
FF MDI 9.6 µg BID
Units
Counts
Participants
OG00048
OG00143
OG00245
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.323(0.249 to 0.397)
OG0010.242(0.165 to 0.319)
OG0020.339(0.264 to 0.415)
OG003
Secondary
Morning Pre-dose FEV1
Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7)
MITT Population
Posted
Least Squares Mean
95% Confidence Interval
Liters
Day 7
ID
Title
Description
OG000
GFF MDI 36/7.2 µg
GFF MDI 36/7.2 µg BID
OG001
GFF MDI 36/9.6 µg
GFF MDI 36/9.6 µg BID
OG002
GFF MDI 18/9.6 µg
GFF MDI 18/9.6 µg BID
OG003
GFF MDI 9/9.6 µg
GFF MDI 9/9.6 µg BID
OG004
GP MDI 36 µg
GP MDI 36 µg BID
OG005
FF MDI 9.6 µg
FF MDI 9.6 µg BID
Units
Counts
Participants
OG00049
OG00143
OG00245
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.152(0.105 to 0.199)
OG0010.110(0.061 to 0.159)
OG0020.122(0.073 to 0.170)
OG003
Secondary
FEV1 Through 6 Hours
Peak change from baseline in FEV1 through 6 hours
MITT Population
Posted
Least Squares Mean
95% Confidence Interval
Liters
Day 7
ID
Title
Description
OG000
GFF MDI 36/7.2 µg
GFF MDI 36/7.2 µg BID
OG001
GFF MDI 36/9.6 µg
GFF MDI 36/9.6 µg BID
OG002
GFF MDI 18/9.6 µg
GFF MDI 18/9.6 µg BID
OG003
GFF MDI 9/9.6 µg
GFF MDI 9/9.6 µg BID
OG004
GP MDI 36 µg
GP MDI 36 µg BID
OG005
FF MDI 9.6 µg
FF MDI 9.6 µg BID
Units
Counts
Participants
OG00050
OG00142
OG00245
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.362(0.309 to 0.414)
OG0010.356(0.300 to 0.412)
OG0020.388(0.334 to 0.443)
OG003
Secondary
Peak Change From Baseline in IC
Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline)
MITT Population
Posted
Least Squares Mean
95% Confidence Interval
Liters
Day 7
ID
Title
Description
OG000
GFF MDI 36/7.2 µg
GFF MDI 36/7.2 µg BID
OG001
GFF MDI 36/9.6 µg
GFF MDI 36/9.6 µg BID
OG002
GFF MDI 18/9.6 µg
GFF MDI 18/9.6 µg BID
OG003
GFF MDI 9/9.6 µg
GFF MDI 9/9.6 µg BID
OG004
GP MDI 36 µg
GP MDI 36 µg BID
OG005
FF MDI 9.6 µg
FF MDI 9.6 µg BID
Units
Counts
Participants
OG00048
OG00143
OG00245
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.333(0.246 to 0.420)
OG0010.267(0.177 to 0.357)
OG0020.340(0.252 to 0.429)
OG003
Secondary
Mean Evening Trough FEV1
Change from baseline in mean evening 12-hour post-dose trough FEV1
MITT Population
Posted
Least Squares Mean
95% Confidence Interval
Liters
Day 7
ID
Title
Description
OG000
GFF MDI 36/7.2 µg
GFF MDI 36/7.2 µg BID
OG001
GFF MDI 36/9.6 µg
GFF MDI 36/9.6 µg BID
OG002
GFF MDI 18/9.6 µg
GFF MDI 18/9.6 µg BID
OG003
GFF MDI 9/9.6 µg
GFF MDI 9/9.6 µg BID
OG004
GP MDI 36 µg
GP MDI 36 µg BID
OG005
FF MDI 9.6 µg
FF MDI 9.6 µg BID
Units
Counts
Participants
OG00048
OG00143
OG00244
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.080(0.032 to 0.129)
OG0010.073(0.023 to 0.123)
OG0020.105(0.055 to 0.154)
OG003
1
58
9
58
EG001
GFF MDI 36/9.6 µg
GFF MDI 36/9.6 µg BID
0
56
4
56
EG002
GFF MDI 18/9.6 µg
GFF MDI 18/9.6 µg BID
0
57
1
57
EG003
GFF MDI 9/9.6 µg
GFF MDI 9/9.6 µg BID
0
57
7
57
EG004
GP MDI 36 µg
GP MDI 36 µg BID
2
61
2
61
EG005
FF MDI 9.6 µg
FF MDI 9.6 µg BID
0
61
8
61
EG0000 events0 affected58 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG0030 events0 affected57 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected61 at risk
Hypokalemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 events1 affected58 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG0030 events0 affected57 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected61 at risk
Renal failure acute
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG0030 events0 affected57 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected61 at risk
EG0003 events3 affected58 at risk
EG0013 events3 affected56 at risk
EG0021 events1 affected57 at risk
EG0035 events5 affected57 at risk
EG0042 events2 affected61 at risk
EG0054 events4 affected61 at risk
Tremor
Nervous system disorders
MedDRA
Systematic Assessment
EG0003 events2 affected58 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG0032 events2 affected57 at risk
EG0040 events0 affected61 at risk
EG0054 events4 affected61 at risk
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0004 events4 affected58 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG0030 events0 affected57 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected61 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.