Trial Outcomes & Findings for Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered With an Electronic eFlow Nebulizer System in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02951312)
NCT ID: NCT02951312
Last Updated: 2018-04-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
0-47 days
Results posted on
2018-04-30
Participant Flow
Participant milestones
| Measure |
25mg Glycopyrrolate, 200mg Gloycopyrrolate
subjects received 25mg Glycopyrrolate then 200mg Glycopyrrolate in part 1- in part 2 subjects from this group either received 200mg Glycopyrrolate or placebo
|
75mg Glycopyrrolate,500mg Glycopyrrolate,1000mg Glycopyrrolate
subjects received 75mg Glycoprrolate, then, 500mg Glycopyrrolate, then 1000mg Glycopyrrolate in part 1 - in part 2 subjects from this group received either 200mg Glycopyrrolate or placebo
|
200mg Glycopyrrolate Jet
subjects received 200mg Glycopyrrolate
|
Placebo
Subjects received placebo
|
|---|---|---|---|---|
|
Study Part 1
STARTED
|
6
|
6
|
0
|
0
|
|
Study Part 1
COMPLETED
|
6
|
6
|
0
|
0
|
|
Study Part 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Study Part 2
STARTED
|
0
|
0
|
6
|
6
|
|
Study Part 2
COMPLETED
|
0
|
0
|
6
|
6
|
|
Study Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered With an Electronic eFlow Nebulizer System in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
25mg Glycopyrrolate, 200mg Gloycopyrrolate
n=6 Participants
subjects received 25mg Glycopyrrolate then 200mg Glycopyrrolate in part 1- in part 2 subjects from this group either received 200mg Glycopyrrolate or placebo
|
75mg Glycopyrrolate,500mg Glycopyrrolate,1000mg Glycopyrrolate
n=6 Participants
subjects received 75mg Glycoprrolate, then, 500mg Glycopyrrolate, then 1000mg Glycopyrrolate in part 1 - in part 2 subjects from this group received either 200mg Glycopyrrolate or placebo
|
200mg Glycopyrrolate Jet
subjects received 200mg Glycopyrrolate
|
Placebo
subjects received placebo
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
—
|
5 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
—
|
7 Participants
n=21 Participants
|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 3.82 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 8.89 • n=7 Participants
|
—
|
—
|
41.67 years
STANDARD_DEVIATION 58.33 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
—
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
—
|
—
|
7 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
—
|
—
|
12 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0-47 daysPopulation: all subjects who received at least one dose of study medication were included in the safety analysis.. A subject received more than one treatment type throughout the study.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
n=6 Participants
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 Participants
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
n=6 Participants
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Died
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 0-47 daysPopulation: all subjects who received at least one dose of study medication were included in the safety analysis.. A subject received more than one treatment type throughout the study.
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
n=6 Participants
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 Participants
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
n=6 Participants
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment Emergent SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 0-47 daysPopulation: all subjects who received at least one dose of study medication were included in the safety analysis. . A subject received more than one treatment type throughout the study.
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
n=6 Participants
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 Participants
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
n=6 Participants
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Discontinued Due to AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 0-47 daysPopulation: all subjects who received at least one dose of study medication were included in the safety analysis. . A subject received more than one treatment type throughout the study.
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
n=6 Participants
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 Participants
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
n=6 Participants
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Treatment Emergent AEs
|
33.3 percentage of participants
|
33.3 percentage of participants
|
66.7 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
PRIMARY outcome
Timeframe: 30 hrs post dosePopulation: all subjects who received at least one dose of study medication were included in the safety analysis. . A subject received more than one treatment type throughout the study.
Vital signs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study assessment. The clinical significance of each out of normal range vital sign parameter was determined by the investigator during the study.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
n=6 Participants
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 Participants
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
n=6 Participants
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: day 47 (post studyfollow-up assessment)Population: all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study.
Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
n=6 Participants
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 Participants
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
n=6 Participants
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30hr post dosePopulation: all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study
ECGs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study follow-up assessment.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
n=6 Participants
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 Participants
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
n=6 Participants
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Clinically Significant ECG Parameters Reported During the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: post study follow-up assessment (Day 47)Population: all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study.
Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
n=6 Participants
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 Participants
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
n=6 Participants
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 0-47 daysPopulation: all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
n=6 Participants
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 Participants
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
n=6 Participants
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment Emergent AEs
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24hr post dosePopulation: All subjects who received at least one dose of study medication and have at least one post baseline efficacy measurement were included in the efficacy population. A subject received more than one treatment type throughout the study.
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the spirometry value collected at 24 hours post dose within each Treatment Period.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
n=6 Participants
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 Participants
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
n=6 Participants
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Trough FEV1 (Change From Baseline)
|
0.038 liters
Standard Deviation 0.157
|
0.087 liters
Standard Deviation 0.062
|
0.138 liters
Standard Deviation 0.079
|
-0.013 liters
Standard Deviation 0.098
|
-0.017 liters
Standard Deviation 0.168
|
0.065 liters
Standard Deviation 0.072
|
-0.030 liters
Standard Deviation 0.070
|
SECONDARY outcome
Timeframe: 0 to 4hrPopulation: all subjects who received at least one dose of the study medication and have at least one post baseline efficacy measurement were included in the efficacy population. . A subject received more than one treatment type throughout the study.
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
n=6 Participants
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 Participants
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
n=6 Participants
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Peak FEV1 (Percent Change)
|
17.12 percent change
Standard Deviation 9.07
|
15.60 percent change
Standard Deviation 4.20
|
22.98 percent change
Standard Deviation 4.99
|
19.28 percent change
Standard Deviation 13.10
|
11.47 percent change
Standard Deviation 6.86
|
16.87 percent change
Standard Deviation 6.83
|
6.80 percent change
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: 0 to 4hrPopulation: All subjects who received at least one dose of study medication and have at least one post baseline efficacy measurement were included in the efficacy population.. A subject received more than one treatment type throughout the study.
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
n=6 Participants
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 Participants
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
n=6 Participants
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Peak FEV1 (Change From Baseline )
|
0.212 liters
Standard Deviation 0.086
|
0.255 liters
Standard Deviation 0.068
|
0.303 liters
Standard Deviation 0.055
|
0.233 liters
Standard Deviation 0.144
|
0.177 liters
Standard Deviation 0.061
|
0.283 liters
Standard Deviation 0.069
|
0.120 liters
Standard Deviation 0.057
|
SECONDARY outcome
Timeframe: 0 to 24hr post dosePopulation: All subjects who received at least one dose of study medication and have at least one post baselineefficacy measurement were included in the efficacy population. A subject received more than one treatment type throughout the study.
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
n=6 Participants
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 Participants
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
n=6 Participants
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
FEV1 AUC0-24 Area Under the FEV1 Over Time Curve (Change From Baseline)
|
1.59 liters
Standard Deviation 3.27
|
3.10 liters
Standard Deviation 2.27
|
3.19 liters
Standard Deviation 1.14
|
1.35 liters
Standard Deviation 2.74
|
1.53 liters
Standard Deviation 2.05
|
3.08 liters
Standard Deviation 1.47
|
-0.11 liters
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: 0 to 12 hours post dosePopulation: All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK . A subject received more than one treatment type throughout the study. analysis.
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Cmax Maximum Observed Plasma Concentration
|
177.242 pg/mL
Standard Deviation 61.469
|
75.530 pg/mL
Standard Deviation 64.950
|
749.872 pg/mL
Standard Deviation 219.696
|
1534.057 pg/mL
Standard Deviation 442.581
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 to 12 hours post dosePopulation: All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis. A subject received more than one treatment type throughout the study.
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
Tmax Time to Maximum Observed Plasma Concentration
|
.025 hours
Standard Deviation 0.088
|
0.08 hours
Standard Deviation 0.088
|
0.25 hours
Standard Deviation 0.069
|
0.17 hours
Standard Deviation 0.093
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 to 12 hourr post dosePopulation: All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis.A subject received more than one treatment type throughout the study.
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
AUC0-t Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration
|
429.335 pg*h/mL
Standard Deviation 192.699
|
26.176 pg*h/mL
Standard Deviation 16.170
|
2014.276 pg*h/mL
Standard Deviation 609.911
|
4084.763 pg*h/mL
Standard Deviation 827.225
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 to 12 hours post dosePopulation: All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis. A subject received more than one treatment type throughout the study.
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity
|
563.416 pg*h/mL
Standard Deviation 235.418
|
65.013 pg*h/mL
Standard Deviation 16.750
|
2491.803 pg*h/mL
Standard Deviation 736.426
|
5271.099 pg*h/mL
Standard Deviation 1096.862
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 to 12 hours post-dosePopulation: Subjects who received at least one dose of study medication and have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis.Subject received more than one treatment type throughout the study samples taken to obtain a plasma concentration by time profile were included in the PK analysis.
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr.
Outcome measures
| Measure |
Glycopyrrolate Inhalation Solution 25mg
n=6 Participants
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 75mg
n=6 Participants
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200mg Jet
n=6 Participants
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500mg
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily
|
Placebo 0.5 mL
Placebo 0.5 mL via jet nebulizer, once daily
Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
|---|---|---|---|---|---|---|---|
|
t1/2 Plasma Half-life
|
2.947 hour
Standard Deviation 1.996
|
0.778 hour
Standard Deviation 0.465
|
6.298 hour
Standard Deviation 1.450
|
7.573 hour
Standard Deviation 1.031
|
—
|
—
|
—
|
Adverse Events
Glycopyrrolate Inhalation Solution 25 μg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Glycopyrrolate Inhalation Solution75μg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Glycopyrrolate Inhalation Solution 200 μg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer,
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Glycopyrrolate Inhalation Solution 500μg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glycopyrrolate Inhalation Solution1000mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Glycopyrrolate Inhalation Solution 25 μg
n=6 participants at risk
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution75μg
n=6 participants at risk
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200 μg
n=6 participants at risk
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer,
n=6 participants at risk
Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer ,once daily
Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution 500μg
n=6 participants at risk
Glycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily
Glycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily
|
Glycopyrrolate Inhalation Solution1000mg
n=6 participants at risk
Glycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily
|
Placebo
n=6 participants at risk
Placebo
Placebo
|
|---|---|---|---|---|---|---|---|
|
General disorders
catheter site related reaction
|
16.7%
1/6 • Number of events 1 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
33.3%
2/6 • Number of events 4 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
33.3%
2/6 • Number of events 2 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
16.7%
1/6 • Number of events 1 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
16.7%
1/6 • Number of events 1 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
|
Infections and infestations
rhinitis
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
16.7%
1/6 • Number of events 1 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal discomfort
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
16.7%
1/6 • Number of events 1 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
|
Nervous system disorders
headache
|
16.7%
1/6 • Number of events 1 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
16.7%
1/6 • Number of events 2 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
50.0%
3/6 • Number of events 4 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
16.7%
1/6 • Number of events 1 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
16.7%
1/6 • Number of events 1 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
33.3%
2/6 • Number of events 2 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
33.3%
2/6 • Number of events 2 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
33.3%
2/6 • Number of events 2 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/6 • 0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
Additional Information
Respiratory Medical Director
Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER