Trial Outcomes & Findings for PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01350128)
NCT ID: NCT01350128
Last Updated: 2018-06-20
Results Overview
FEV1 AUC0-12 following chronic dosing (1 week), normalized.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)
Results posted on
2018-06-20
Participant Flow
Conducted at 9 US sites from May-October 2011. Entire period of study participation per subject was a maximum of 15 weeks. Planned target enrollment of 84 subjects.
This was a chronic dosing study (7 days), 3-period, 6-treatment, incomplete block, crossover study. Each subject received 3 of 6 possible treatments; each treatment period was separated by a washout period 7-28 days. By-treatment sequence tabulations of the data were not pre-specified.
Participant milestones
| Measure |
All Subjects Randomized
|
|---|---|
|
Overall Study
STARTED
|
103
|
|
Overall Study
GP MDI 36 µg BID
|
49
|
|
Overall Study
GP MDI 18 µg BID
|
49
|
|
Overall Study
GP MDI 9 µg BID
|
49
|
|
Overall Study
GP MDI 4.6 µg BID
|
45
|
|
Overall Study
Placebo MDI BID
|
48
|
|
Overall Study
Atrovent HFA 34 µg BID
|
48
|
|
Overall Study
COMPLETED
|
89
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
All Subjects Randomized
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Protocol discontinuation criteria
|
8
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
ITT Population
n=103 Participants
ITT Population includes all subjects who were randomized, received at least 1 dose of study treatment, and had both baseline and post-baseline efficacy data for that treatment.
|
|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 8.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)Population: Modified Intent to Treat (MITT) Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.
FEV1 AUC0-12 following chronic dosing (1 week), normalized.
Outcome measures
| Measure |
PT001 MDI 36 µg BID
n=40 Participants
PT001 MDI 36 µg BID.
|
PT001 MDI 18 µg BID
n=41 Participants
PT001 MDI 18 µg BID.
|
PT001 MDI 9 µg BID
n=41 Participants
PT001 MDI 9 µg BID
|
PT001 MDI 4.6 µg BID
n=39 Participants
PT001 MDI 4.6 µg BID.
|
Ipratropium Bromide HFA Inhalation Aerosol
n=42 Participants
Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
|
Placebo MDI BID
n=40 Participants
Placebo MDI BID.
|
|---|---|---|---|---|---|---|
|
FEV1 AUC0-12
|
1.477 Liter
Interval 1.418 to 1.537
|
1.497 Liter
Interval 1.437 to 1.556
|
1.443 Liter
Interval 1.385 to 1.501
|
1.514 Liter
Interval 1.456 to 1.572
|
1.465 Liter
Interval 1.405 to 1.524
|
1.323 Liter
Interval 1.263 to 1.382
|
SECONDARY outcome
Timeframe: Day 1Population: MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.
Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted)
Outcome measures
| Measure |
PT001 MDI 36 µg BID
n=45 Participants
PT001 MDI 36 µg BID.
|
PT001 MDI 18 µg BID
n=46 Participants
PT001 MDI 18 µg BID.
|
PT001 MDI 9 µg BID
n=44 Participants
PT001 MDI 9 µg BID
|
PT001 MDI 4.6 µg BID
n=41 Participants
PT001 MDI 4.6 µg BID.
|
Ipratropium Bromide HFA Inhalation Aerosol
n=44 Participants
Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
|
Placebo MDI BID
n=46 Participants
Placebo MDI BID.
|
|---|---|---|---|---|---|---|
|
Peak Change From Baseline in FEV1 on Day 1
|
0.245 Liter
95% Confidence Interval 0.0252 • Interval 0.195 to 0.295
|
0.221 Liter
95% Confidence Interval 0.0247 • Interval 0.172 to 0.27
|
0.181 Liter
95% Confidence Interval 0.0256 • Interval 0.13 to 0.232
|
0.204 Liter
95% Confidence Interval 0.0206 • Interval 0.153 to 0.255
|
0.250 Liter
95% Confidence Interval 0.0258 • Interval 0.198 to 0.301
|
0.071 Liter
95% Confidence Interval 0.0251 • Interval 0.021 to 0.12
|
SECONDARY outcome
Timeframe: Day 1 (15 min, 30 min, 1 hour, 2 hours)Population: MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.
Time to onset of action ( ≥10% improvement in FEV1)
Outcome measures
| Measure |
PT001 MDI 36 µg BID
n=44 Participants
PT001 MDI 36 µg BID.
|
PT001 MDI 18 µg BID
n=45 Participants
PT001 MDI 18 µg BID.
|
PT001 MDI 9 µg BID
n=43 Participants
PT001 MDI 9 µg BID
|
PT001 MDI 4.6 µg BID
n=40 Participants
PT001 MDI 4.6 µg BID.
|
Ipratropium Bromide HFA Inhalation Aerosol
n=44 Participants
Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
|
Placebo MDI BID
n=45 Participants
Placebo MDI BID.
|
|---|---|---|---|---|---|---|
|
Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1
30 minutes
|
32 % of subjects
|
18 % of subjects
|
7 % of subjects
|
20 % of subjects
|
25 % of subjects
|
9 % of subjects
|
|
Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1
15 minutes
|
32 % of subjects
|
31 % of subjects
|
19 % of subjects
|
25 % of subjects
|
48 % of subjects
|
7 % of subjects
|
|
Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1
1 hour
|
5 % of subjects
|
11 % of subjects
|
23 % of subjects
|
8 % of subjects
|
9 % of subjects
|
4 % of subjects
|
|
Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1
2 hours
|
2 % of subjects
|
13 % of subjects
|
14 % of subjects
|
15 % of subjects
|
2 % of subjects
|
13 % of subjects
|
|
Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1
No onset within 2 hours
|
30 % of subjects
|
27 % of subjects
|
37 % of subjects
|
33 % of subjects
|
16 % of subjects
|
67 % of subjects
|
SECONDARY outcome
Timeframe: Day 1Population: MITT Population: This includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.
Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline)
Outcome measures
| Measure |
PT001 MDI 36 µg BID
n=45 Participants
PT001 MDI 36 µg BID.
|
PT001 MDI 18 µg BID
n=46 Participants
PT001 MDI 18 µg BID.
|
PT001 MDI 9 µg BID
n=44 Participants
PT001 MDI 9 µg BID
|
PT001 MDI 4.6 µg BID
n=41 Participants
PT001 MDI 4.6 µg BID.
|
Ipratropium Bromide HFA Inhalation Aerosol
n=45 Participants
Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
|
Placebo MDI BID
n=46 Participants
Placebo MDI BID.
|
|---|---|---|---|---|---|---|
|
Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1
|
66.67 Percent
|
58.70 Percent
|
52.27 Percent
|
60.98 Percent
|
77.78 Percent
|
17.39 Percent
|
SECONDARY outcome
Timeframe: Day 1Population: MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.
Peak change from baseline in Inspiratory Capacity (IC) on Day 1 (mean of 1 and 2 hours post-dose minus baseline on Day 1)
Outcome measures
| Measure |
PT001 MDI 36 µg BID
n=45 Participants
PT001 MDI 36 µg BID.
|
PT001 MDI 18 µg BID
n=45 Participants
PT001 MDI 18 µg BID.
|
PT001 MDI 9 µg BID
n=44 Participants
PT001 MDI 9 µg BID
|
PT001 MDI 4.6 µg BID
n=41 Participants
PT001 MDI 4.6 µg BID.
|
Ipratropium Bromide HFA Inhalation Aerosol
n=45 Participants
Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
|
Placebo MDI BID
n=46 Participants
Placebo MDI BID.
|
|---|---|---|---|---|---|---|
|
Peak Change From Baseline in IC on Day 1
|
0.240 Liter
95% Confidence Interval 0.0379 • Interval 0.165 to 0.316
|
0.276 Liter
95% Confidence Interval 0.0377 • Interval 0.201 to 0.351
|
0.185 Liter
95% Confidence Interval 0.0374 • Interval 0.111 to 0.259
|
0.187 Liter
95% Confidence Interval 0.0380 • Interval 0.111 to 0.262
|
0.252 Liter
95% Confidence Interval 0.0396 • Interval 0.173 to 0.33
|
0.040 Liter
95% Confidence Interval 0.0385 • Interval -0.036 to 0.117
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.
Change from baseline in morning pre-dose FEV1
Outcome measures
| Measure |
PT001 MDI 36 µg BID
n=45 Participants
PT001 MDI 36 µg BID.
|
PT001 MDI 18 µg BID
n=45 Participants
PT001 MDI 18 µg BID.
|
PT001 MDI 9 µg BID
n=43 Participants
PT001 MDI 9 µg BID
|
PT001 MDI 4.6 µg BID
n=41 Participants
PT001 MDI 4.6 µg BID.
|
Ipratropium Bromide HFA Inhalation Aerosol
n=43 Participants
Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
|
Placebo MDI BID
n=46 Participants
Placebo MDI BID.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose FEV1 on Day 7
|
0.088 Liter
95% Confidence Interval 0.0246 • Interval 0.039 to 0.136
|
0.075 Liter
95% Confidence Interval 0.0245 • Interval 0.027 to 0.124
|
0.010 Liter
95% Confidence Interval 0.0248 • Interval -0.039 to 0.059
|
0.084 Liter
95% Confidence Interval 0.0247 • Interval 0.035 to 0.133
|
-0.088 Liter
95% Confidence Interval 0.0256 • Interval -0.138 to -0.037
|
-0.043 Liter
95% Confidence Interval 0.0246 • Interval -0.092 to 0.006
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.
Peak change from baseline in FEV1
Outcome measures
| Measure |
PT001 MDI 36 µg BID
n=45 Participants
PT001 MDI 36 µg BID.
|
PT001 MDI 18 µg BID
n=45 Participants
PT001 MDI 18 µg BID.
|
PT001 MDI 9 µg BID
n=43 Participants
PT001 MDI 9 µg BID
|
PT001 MDI 4.6 µg BID
n=41 Participants
PT001 MDI 4.6 µg BID.
|
Ipratropium Bromide HFA Inhalation Aerosol
n=43 Participants
Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
|
Placebo MDI BID
n=44 Participants
Placebo MDI BID.
|
|---|---|---|---|---|---|---|
|
Peak Change From Baseline in FEV1 on Day 7
|
0.242 Liter
95% Confidence Interval 0.0303 • Interval 0.181 to 0.302
|
0.224 Liter
95% Confidence Interval 0.0300 • Interval 0.164 to 0.284
|
0.223 Liter
95% Confidence Interval 0.0307 • Interval 0.162 to 0.285
|
0.238 Liter
95% Confidence Interval 0.0308 • Interval 0.176 to 0.3
|
0.225 Liter
95% Confidence Interval 0.0307 • Interval 0.164 to 0.287
|
0.070 Liter
95% Confidence Interval 0.0305 • Interval 0.009 to 0.131
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.
Peak change from baseline in IC
Outcome measures
| Measure |
PT001 MDI 36 µg BID
n=45 Participants
PT001 MDI 36 µg BID.
|
PT001 MDI 18 µg BID
n=45 Participants
PT001 MDI 18 µg BID.
|
PT001 MDI 9 µg BID
n=43 Participants
PT001 MDI 9 µg BID
|
PT001 MDI 4.6 µg BID
n=41 Participants
PT001 MDI 4.6 µg BID.
|
Ipratropium Bromide HFA Inhalation Aerosol
n=43 Participants
Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
|
Placebo MDI BID
n=44 Participants
Placebo MDI BID.
|
|---|---|---|---|---|---|---|
|
Peak Change From Baseline in IC on Day 7
|
0.213 Liters
95% Confidence Interval 0.0416 • Interval 0.13 to 0.295
|
0.189 Liters
95% Confidence Interval 0.0411 • Interval 0.107 to 0.271
|
0.161 Liters
95% Confidence Interval 0.0424 • Interval 0.077 to 0.245
|
0.192 Liters
95% Confidence Interval 0.0426 • Interval 0.107 to 0.277
|
0.191 Liters
95% Confidence Interval 0.0424 • Interval 0.106 to 0.275
|
-0.029 Liters
95% Confidence Interval 0.0419 • Interval -0.112 to 0.055
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.
Change from baseline in 12-hour post-dose trough FEV1
Outcome measures
| Measure |
PT001 MDI 36 µg BID
n=40 Participants
PT001 MDI 36 µg BID.
|
PT001 MDI 18 µg BID
n=41 Participants
PT001 MDI 18 µg BID.
|
PT001 MDI 9 µg BID
n=41 Participants
PT001 MDI 9 µg BID
|
PT001 MDI 4.6 µg BID
n=39 Participants
PT001 MDI 4.6 µg BID.
|
Ipratropium Bromide HFA Inhalation Aerosol
n=42 Participants
Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
|
Placebo MDI BID
n=41 Participants
Placebo MDI BID.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7
|
0.018 Liters
95% Confidence Interval 0.0313 • Interval -0.045 to 0.08
|
0.079 Liters
95% Confidence Interval 0.0304 • Interval 0.018 to 0.139
|
0.004 Liters
95% Confidence Interval 0.0306 • Interval -0.057 to 0.065
|
0.077 Liters
95% Confidence Interval 0.0307 • Interval 0.016 to 0.139
|
-0.041 Liters
95% Confidence Interval 0.0311 • Interval -0.103 to 0.021
|
-0.054 Liters
95% Confidence Interval 0.0316 • Interval -0.117 to 0.009
|
Adverse Events
PT001 MDI 36 µg BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PT001 MDI 18 µg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PT001 MDI 9 µg BID
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PT001 MDI 4.6 µg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Ipratropium Bromide HFA Inhalation Aerosol
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PT001 MDI 36 µg BID
n=49 participants at risk
PT001 MDI 36 µg BID.
|
PT001 MDI 18 µg BID
n=49 participants at risk
PT001 MDI 18 µg BID.
|
PT001 MDI 9 µg BID
n=49 participants at risk
PT001 MDI 9 µg BID
|
PT001 MDI 4.6 µg BID
n=45 participants at risk
PT001 MDI 4.6 µg BID.
|
Ipratropium Bromide HFA Inhalation Aerosol
n=48 participants at risk
Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
|
Placebo BID
n=48 participants at risk
Placebo BID.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
0.00%
0/49 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
0.00%
0/49 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
0.00%
0/49 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
2.2%
1/45 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
0.00%
0/48 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
0.00%
0/48 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/49 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
0.00%
0/49 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
0.00%
0/49 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
0.00%
0/45 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
2.1%
1/48 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
0.00%
0/48 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
Other adverse events
| Measure |
PT001 MDI 36 µg BID
n=49 participants at risk
PT001 MDI 36 µg BID.
|
PT001 MDI 18 µg BID
n=49 participants at risk
PT001 MDI 18 µg BID.
|
PT001 MDI 9 µg BID
n=49 participants at risk
PT001 MDI 9 µg BID
|
PT001 MDI 4.6 µg BID
n=45 participants at risk
PT001 MDI 4.6 µg BID.
|
Ipratropium Bromide HFA Inhalation Aerosol
n=48 participants at risk
Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
|
Placebo BID
n=48 participants at risk
Placebo BID.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
2.0%
1/49 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
4.1%
2/49 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
8.2%
4/49 • Number of events 4 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
8.9%
4/45 • Number of events 4 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
6.2%
3/48 • Number of events 3 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
2.1%
1/48 • 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.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
|
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