Trial Outcomes & Findings for A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD (NCT NCT02937584)
NCT ID: NCT02937584
Last Updated: 2019-07-24
Results Overview
Specific image-based airway volume. Average across lobe, adjusted for lobe volume. Ratio to baseline
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
Baseline, Day 15
Results posted on
2019-07-24
Participant Flow
This study randomized 23 subjects at 2 sites in Belgium from December 2016 to May 2018.
Subjects were randomized into 1 of 2 treatment sequences. Sequence 1 received GP MDI in Period 1 followed by FF MDI in Period 2. Sequence 2 received FF MDI in Period 1 followed by GP MDI in Period 2.
Participant milestones
| Measure |
GP MDI/ FF MDI
Glycopyrronium Metered Dose Inhalation /Formoterol Fumarate Metered Dose Inhalation
|
FF MDI/GP MDI
Formoterol Fumarate Metered Dose Inhalation / Glycopyrronium Metered Dose Inhalation
|
|---|---|---|
|
Period 1
STARTED
|
11
|
12
|
|
Period 1
COMPLETED
|
10
|
10
|
|
Period 1
NOT COMPLETED
|
1
|
2
|
|
Washout
STARTED
|
10
|
10
|
|
Washout
COMPLETED
|
10
|
9
|
|
Washout
NOT COMPLETED
|
0
|
1
|
|
Period 2
STARTED
|
10
|
9
|
|
Period 2
COMPLETED
|
10
|
9
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
GP MDI/ FF MDI
Glycopyrronium Metered Dose Inhalation /Formoterol Fumarate Metered Dose Inhalation
|
FF MDI/GP MDI
Formoterol Fumarate Metered Dose Inhalation / Glycopyrronium Metered Dose Inhalation
|
|---|---|---|
|
Period 1
Adverse Event
|
1
|
2
|
|
Washout
Adverse Event
|
0
|
1
|
Baseline Characteristics
ITT Population
Baseline characteristics by cohort
| Measure |
Overall Study
n=23 Participants
ITT Population
|
|---|---|
|
Age, Continuous
|
64.6 Years
STANDARD_DEVIATION 9.6 • n=5 Participants • ITT Population
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants • ITT Population
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants • ITT Population
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • ITT Population
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • ITT Population
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • ITT Population
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • ITT Population
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants • ITT Population
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • ITT Population
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • ITT Population
|
PRIMARY outcome
Timeframe: Baseline, Day 15Population: ITT Population
Specific image-based airway volume. Average across lobe, adjusted for lobe volume. Ratio to baseline
Outcome measures
| Measure |
GP MDI
n=19 Participants
Glycopyrronium Metered Dose Inhalation
|
FF MDI
n=19 Participants
FF MDI Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Specific Image-Based Airway Volume (siVaw)
|
1.11 ratio
Interval 1.02 to 1.22
|
1.23 ratio
Interval 1.14 to 1.33
|
PRIMARY outcome
Timeframe: Baseline, Day 15Population: ITT Population
Specific image-based airway resistance (siRaw). Average across lobes, adjusted for lobe volume. Ratio to baseline.
Outcome measures
| Measure |
GP MDI
n=19 Participants
Glycopyrronium Metered Dose Inhalation
|
FF MDI
n=19 Participants
FF MDI Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Specific Image-based Airway Resistance (siRaw)
|
0.75 ratio
Interval 0.59 to 0.95
|
0.56 ratio
Interval 0.44 to 0.71
|
SECONDARY outcome
Timeframe: Baseline, Day 15Population: ITT Population
Image-based airway volume (iVaw) without correction for lobe volume. Ratio to baseline.
Outcome measures
| Measure |
GP MDI
n=19 Participants
Glycopyrronium Metered Dose Inhalation
|
FF MDI
n=19 Participants
FF MDI Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Image-based Airway Volume (iVaw)
|
1.12 ratio
Interval 1.01 to 1.24
|
1.21 ratio
Interval 1.12 to 1.31
|
SECONDARY outcome
Timeframe: Baseline, Day 15Population: ITT Population
Image-based airway resistance (iRaw) without correction for lobe volume. Ratio to baseline.
Outcome measures
| Measure |
GP MDI
n=19 Participants
Glycopyrronium Metered Dose Inhalation
|
FF MDI
n=19 Participants
FF MDI Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Image-based Airway Resistance (iRaw)
|
0.76 ratio
Interval 0.59 to 0.97
|
0.55 ratio
Interval 0.41 to 0.72
|
SECONDARY outcome
Timeframe: Baseline, Day 15Population: ITT Population
FEV1 Change from baseline in Forced Expiratory Volume at 1 second.
Outcome measures
| Measure |
GP MDI
n=19 Participants
Glycopyrronium Metered Dose Inhalation
|
FF MDI
n=19 Participants
FF MDI Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
FEV1
|
0.065 L
Standard Deviation 0.193
|
0.151 L
Standard Deviation 0.293
|
SECONDARY outcome
Timeframe: Baseline, Day 15Population: ITT Population
Functional residual capacity (FRC). Ratio to baseline.
Outcome measures
| Measure |
GP MDI
n=19 Participants
Glycopyrronium Metered Dose Inhalation
|
FF MDI
n=19 Participants
FF MDI Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Functional Residual Capacity (FRC)
|
0.978 ratio
Interval 0.891 to 1.073
|
0.938 ratio
Interval 0.833 to 1.056
|
Adverse Events
GP MDI
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
FF MDI
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GP MDI
n=20 participants at risk
Glycopyrronium Metered Dose Inhalation
|
FF MDI
n=22 participants at risk
FF MDI Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/22 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/20 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
Other adverse events
| Measure |
GP MDI
n=20 participants at risk
Glycopyrronium Metered Dose Inhalation
|
FF MDI
n=22 participants at risk
FF MDI Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
13.6%
3/22 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Infections and infestations
Influenza
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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 it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER