Trial Outcomes & Findings for 24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003 and Placebo MDI (NCT NCT02347085)
NCT ID: NCT02347085
Last Updated: 2018-07-19
Results Overview
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC)0-24 on Day 29
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
43 participants
Primary outcome timeframe
Day 29
Results posted on
2018-07-19
Participant Flow
This study was conducted at 5 sites in the US from March 2015 to Jun 2015. The study was anticipated to run for approximately 6 months but not to expected to exceed 9 months.The study period was 11 to 17 weeks for each subject.
Complete crossover study to assess the efficacy and safety of GFF MDI vs. Placebo MDI. Each subject received 28 days of study treatment in each assigned treatment, with a minimum 7 day washout period between each of the 2 periods. By-treatment sequence tabulations of the data were not pre-specified.
Participant milestones
| Measure |
Overall Study
All subjects randomized
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
GFF MDI 14.4/9.6 µg
|
40
|
|
Overall Study
Placebo MDI
|
40
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Overall Study
All subjects randomized
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Criteria
|
2
|
Baseline Characteristics
24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003 and Placebo MDI
Baseline characteristics by cohort
| Measure |
All Subjects
n=35 Participants
|
|---|---|
|
Age, Continuous
|
61.3 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Modified-Intent-to-Treat (MITT) Population
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC)0-24 on Day 29
Outcome measures
| Measure |
GFF MD (PT003)
n=35 Participants
GFF MDI 14.4/9.6 µg
|
Placebo
n=31 Participants
Placebo MDI
|
|---|---|---|
|
FEV1 AUC0-24 on Day 29
|
0.166 Liters
Interval 0.11 to 0.222
|
-0.083 Liters
Interval -0.143 to -0.024
|
SECONDARY outcome
Timeframe: Day 29Population: MITT Population
FEV1 AUC12-24 on Day 29
Outcome measures
| Measure |
GFF MD (PT003)
n=35 Participants
GFF MDI 14.4/9.6 µg
|
Placebo
n=31 Participants
Placebo MDI
|
|---|---|---|
|
FEV1 AUC12-24 on Day 29
|
0.115 Liters
Interval 0.055 to 0.175
|
-0.127 Liters
Interval -0.191 to -0.063
|
SECONDARY outcome
Timeframe: Day 29Population: MITT Population
FEV1 AUC0-12 on Day 29
Outcome measures
| Measure |
GFF MD (PT003)
n=35 Participants
GFF MDI 14.4/9.6 µg
|
Placebo
n=31 Participants
Placebo MDI
|
|---|---|---|
|
FEV1 AUC0-12 on Day 29
|
0.216 Liters
Interval 0.157 to 0.276
|
-0.039 Liters
Interval -0.103 to 0.025
|
SECONDARY outcome
Timeframe: Day 29Population: MITT Population
Peak Change From Baseline in FEV1 following evening Dose on Day 29
Outcome measures
| Measure |
GFF MD (PT003)
n=35 Participants
GFF MDI 14.4/9.6 µg
|
Placebo
n=31 Participants
Placebo MDI
|
|---|---|---|
|
Peak Change From Baseline in FEV1 on Day 29
|
0.344 Liters
Interval 0.275 to 0.412
|
0.050 Liters
Interval -0.023 to 0.124
|
SECONDARY outcome
Timeframe: Day 29Population: MITT Population
Peak Change From Baseline in FEV1 following the morning dose on Day 29
Outcome measures
| Measure |
GFF MD (PT003)
n=35 Participants
GFF MDI 14.4/9.6 µg
|
Placebo
n=31 Participants
Placebo MDI
|
|---|---|---|
|
Peak Change From Baseline in FEV1 on Day 29
|
0.410 Liters
Interval 0.338 to 0.482
|
0.134 Liters
Interval 0.058 to 0.209
|
SECONDARY outcome
Timeframe: Day 29Population: MITT Population
Morning Pre-Dose Trough FEV on Day 29
Outcome measures
| Measure |
GFF MD (PT003)
n=35 Participants
GFF MDI 14.4/9.6 µg
|
Placebo
n=32 Participants
Placebo MDI
|
|---|---|---|
|
Morning Pre-Dose Trough FEV1 on Day 29
|
0.130 Liters
Interval 0.086 to 0.173
|
-0.012 Liters
Interval -0.058 to 0.033
|
SECONDARY outcome
Timeframe: Day 30Population: MITT Population
Morning Pre-Dose Trough FEV1 on Day 30
Outcome measures
| Measure |
GFF MD (PT003)
n=35 Participants
GFF MDI 14.4/9.6 µg
|
Placebo
n=31 Participants
Placebo MDI
|
|---|---|---|
|
Morning Pre-Dose Trough FEV1 on Day 30
|
0.090 Liters
Interval 0.032 to 0.148
|
-0.064 Liters
Interval -0.124 to -0.003
|
SECONDARY outcome
Timeframe: Day 29Population: MITT Population
Peak Change from Baseline in Inspiratory Capacity (IC) following the evening dose on Day 29
Outcome measures
| Measure |
GFF MD (PT003)
n=34 Participants
GFF MDI 14.4/9.6 µg
|
Placebo
n=30 Participants
Placebo MDI
|
|---|---|---|
|
Peak Change From Baseline in Inspiratory Capacity (IC) Following the Evening Dose on Day 29
|
0.486 Liters
Interval 0.369 to 0.603
|
0.105 Liters
Interval -0.019 to 0.229
|
SECONDARY outcome
Timeframe: Day 29Population: MITT Population
Peak Change from Baseline in IC following the morning dose on Day 29
Outcome measures
| Measure |
GFF MD (PT003)
n=35 Participants
GFF MDI 14.4/9.6 µg
|
Placebo
n=31 Participants
Placebo MDI
|
|---|---|---|
|
Peak Change From Baseline in IC Following the Morning Dose on Day 29
|
0.543 Liters
Interval 0.448 to 0.639
|
0.208 Liters
Interval 0.106 to 0.31
|
Adverse Events
GFF MDI PT003
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GFF MDI PT003
n=40 participants at risk
GFF MDI 14.4/9.6 µg
|
Placebo
n=40 participants at risk
Placebo MDI
|
|---|---|---|
|
Infections and infestations
Abscess limb
|
0.00%
0/40 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after 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.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after 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
Gastroenteritis
|
2.5%
1/40 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after 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%
0/40 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after 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 |
GFF MDI PT003
n=40 participants at risk
GFF MDI 14.4/9.6 µg
|
Placebo
n=40 participants at risk
Placebo MDI
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/40 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after 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.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after 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.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/40 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after 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.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after 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
Hypertenstion
|
2.5%
1/40 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after 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.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after 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
Colin Reisner, MD, FCCP, FAAAAI
Pearl Therapeutics Inc.
Phone: 650-305-2600
Email: [email protected]
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 its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER