Trial Outcomes & Findings for A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD (NCT NCT06545500)
NCT ID: NCT06545500
Last Updated: 2026-02-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Baseline (pre-dose for each treatment period) and Day 7
Results posted on
2026-02-09
Participant Flow
Demographic and baseline characteristics are presented by sequence assignment based on which treatment sequence the participant was randomized to. Each treatment sequence was comprised of four treatment periods with a different dose level being received during each period. Therefore, each participant received each dose and there is no demographic or baseline data based dose alone.
Participant milestones
| Measure |
Sequence 1
Participants assigned to treatment Sequence 1 received dose level A for treatment period 1, followed by dose level D for treatment period 2, then dose level B for treatment period 3, and finished with dose level C for treatment period 4
|
Sequence 2
Participants assigned to treatment Sequence 2 received dose level B for treatment period 1, followed by dose level A for treatment period 2, then dose level C for treatment period 3, and finished with dose level D for treatment period 4
|
Sequence 3
Participants assigned to treatment Sequence 3 received dose level C for treatment period 1, followed by dose level B for treatment period 2, then dose level D for treatment period 3, and finished with dose level A for treatment period 4
|
Sequence 4
Participants assigned to treatment Sequence 4 received dose level D for treatment period 1, followed by dose level C for treatment period 2, then dose level A for treatment period 3, and finished with dose level B for treatment period 4
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
12
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Sequence 1
Participants assigned to treatment Sequence 1 received dose level A for treatment period 1, followed by dose level D for treatment period 2, then dose level B for treatment period 3, and finished with dose level C for treatment period 4
|
Sequence 2
Participants assigned to treatment Sequence 2 received dose level B for treatment period 1, followed by dose level A for treatment period 2, then dose level C for treatment period 3, and finished with dose level D for treatment period 4
|
Sequence 3
Participants assigned to treatment Sequence 3 received dose level C for treatment period 1, followed by dose level B for treatment period 2, then dose level D for treatment period 3, and finished with dose level A for treatment period 4
|
Sequence 4
Participants assigned to treatment Sequence 4 received dose level D for treatment period 1, followed by dose level C for treatment period 2, then dose level A for treatment period 3, and finished with dose level B for treatment period 4
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Not Wanting Further Contact
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal of Consent
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal Due to Hurricane
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Demographic is specific to female population only
Baseline characteristics by cohort
| Measure |
Sequence 1
n=12 Participants
Participants assigned to treatment Sequence 1 received dose level A for treatment period 1, followed by dose level D for treatment period 2, then dose level B for treatment period 3, and finished with dose level C for treatment period 4
|
Sequence 2
n=11 Participants
Participants assigned to treatment Sequence 2 received dose level B for treatment period 1, followed by dose level A for treatment period 2, then dose level C for treatment period 3, and finished with dose level D for treatment period 4
|
Sequence 3
n=12 Participants
Participants assigned to treatment Sequence 3 received dose level C for treatment period 1, followed by dose level B for treatment period 2, then dose level D for treatment period 3, and finished with dose level A for treatment period 4
|
Sequence 4
n=11 Participants
Participants assigned to treatment Sequence 4 received dose level D for treatment period 1, followed by dose level C for treatment period 2, then dose level A for treatment period 3, and finished with dose level B for treatment period 4
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.5 Years
STANDARD_DEVIATION 7.15 • n=12 Participants
|
68.7 Years
STANDARD_DEVIATION 4.54 • n=11 Participants
|
62.5 Years
STANDARD_DEVIATION 9.17 • n=12 Participants
|
66.1 Years
STANDARD_DEVIATION 6.28 • n=11 Participants
|
65.1 Years
STANDARD_DEVIATION 7.24 • n=46 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=12 Participants
|
6 Participants
n=11 Participants
|
7 Participants
n=12 Participants
|
7 Participants
n=11 Participants
|
28 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=12 Participants
|
5 Participants
n=11 Participants
|
5 Participants
n=12 Participants
|
4 Participants
n=11 Participants
|
18 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=12 Participants
|
9 Participants
n=11 Participants
|
12 Participants
n=12 Participants
|
10 Participants
n=11 Participants
|
40 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=12 Participants
|
2 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
6 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
HISPANIC OR LATINO
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
NOT HISPANIC OR LATINO
|
10 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
12 Participants
n=12 Participants
|
9 Participants
n=11 Participants
|
42 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
NOT REPORTED
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=11 Participants
|
3 Participants
n=46 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
12 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
46 Participants
n=46 Participants
|
|
Body mass index
|
29.68 kg/m^2
STANDARD_DEVIATION 6.284 • n=12 Participants
|
29.04 kg/m^2
STANDARD_DEVIATION 2.363 • n=11 Participants
|
28.98 kg/m^2
STANDARD_DEVIATION 9.098 • n=12 Participants
|
27.55 kg/m^2
STANDARD_DEVIATION 4.473 • n=11 Participants
|
28.83 kg/m^2
STANDARD_DEVIATION 6.016 • n=46 Participants
|
|
Childbearing potential
Yes
|
0 Participants
n=8 Participants • Demographic is specific to female population only
|
0 Participants
n=6 Participants • Demographic is specific to female population only
|
0 Participants
n=7 Participants • Demographic is specific to female population only
|
0 Participants
n=7 Participants • Demographic is specific to female population only
|
0 Participants
n=28 Participants • Demographic is specific to female population only
|
|
Childbearing potential
No
|
8 Participants
n=8 Participants • Demographic is specific to female population only
|
6 Participants
n=6 Participants • Demographic is specific to female population only
|
7 Participants
n=7 Participants • Demographic is specific to female population only
|
7 Participants
n=7 Participants • Demographic is specific to female population only
|
28 Participants
n=28 Participants • Demographic is specific to female population only
|
PRIMARY outcome
Timeframe: Baseline (pre-dose for each treatment period) and Day 7Outcome measures
| Measure |
Dose Level A Glycopyrrolate (85 μg)
n=39 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level B Glycopyrrolate (42.5 μg)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level C Glycopyrrolate (14 μg)
n=41 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level D (Placebo)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
|---|---|---|---|---|
|
Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
|
0.0525 Liters
Standard Error 0.02125
|
0.0393 Liters
Standard Error 0.02135
|
0.0115 Liters
Standard Error 0.02069
|
-0.0287 Liters
Standard Error 0.02029
|
SECONDARY outcome
Timeframe: Baseline (pre-dose for each treatment period) and Day 7Outcome measures
| Measure |
Dose Level A Glycopyrrolate (85 μg)
n=39 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level B Glycopyrrolate (42.5 μg)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level C Glycopyrrolate (14 μg)
n=41 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level D (Placebo)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
|---|---|---|---|---|
|
Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours
|
0.2333 Liters
Standard Error 0.02304
|
0.2042 Liters
Standard Error 0.02314
|
0.1568 Liters
Standard Error 0.02243
|
0.0520 Liters
Standard Error 0.02200
|
SECONDARY outcome
Timeframe: Baseline (pre-dose for each treatment period) and Day 7The endpoint is measured as AUC/4 hour time interval resulting in an average volume measure in liters.
Outcome measures
| Measure |
Dose Level A Glycopyrrolate (85 μg)
n=39 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level B Glycopyrrolate (42.5 μg)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level C Glycopyrrolate (14 μg)
n=41 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level D (Placebo)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
|---|---|---|---|---|
|
Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h)
|
0.0969 Liters
Standard Error 0.02037
|
0.0693 Liters
Standard Error 0.02046
|
0.0418 Liters
Standard Error 0.01984
|
-0.0403 Liters
Standard Error 0.01945
|
SECONDARY outcome
Timeframe: Baseline (pre-dose for each treatment period) and Day 7The endpoint is measured as AUC/12 hour time interval resulting in an average volume measure in liters.
Outcome measures
| Measure |
Dose Level A Glycopyrrolate (85 μg)
n=39 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level B Glycopyrrolate (42.5 μg)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level C Glycopyrrolate (14 μg)
n=41 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level D (Placebo)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
|---|---|---|---|---|
|
Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 12 Hours (AUC0-12h)
|
0.0916 Liters
Standard Error 0.02006
|
0.0656 Liters
Standard Error 0.02031
|
0.0338 Liters
Standard Error 0.02039
|
-0.0449 Liters
Standard Error 0.01927
|
SECONDARY outcome
Timeframe: Baseline (pre-dose for each treatment period) and Day 7Outcome measures
| Measure |
Dose Level A Glycopyrrolate (85 μg)
n=39 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level B Glycopyrrolate (42.5 μg)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level C Glycopyrrolate (14 μg)
n=41 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level D (Placebo)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
|---|---|---|---|---|
|
Change From Average Baseline FEV1 to Evening Trough FEV1
|
0.0652 Liters
Standard Error 0.02054
|
0.0569 Liters
Standard Error 0.02066
|
0.0091 Liters
Standard Error 0.02115
|
-0.0484 Liters
Standard Error 0.01996
|
SECONDARY outcome
Timeframe: Baseline (pre-dose) and Day 1Outcome measures
| Measure |
Dose Level A Glycopyrrolate (85 μg)
n=39 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level B Glycopyrrolate (42.5 μg)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level C Glycopyrrolate (14 μg)
n=41 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level D (Placebo)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
|---|---|---|---|---|
|
Change From Average Baseline FEV1 to Peak FEV1 Measured Over 4 Hours After First Dose
|
0.2117 Liters
Standard Error 0.01786
|
0.1872 Liters
Standard Error 0.01798
|
0.1643 Liters
Standard Error 0.01675
|
0.0730 Liters
Standard Error 0.01716
|
SECONDARY outcome
Timeframe: Baseline (pre-dose) and Day 1The endpoint is measured as AUC/4 hour time interval resulting in an average volume measure in liters.
Outcome measures
| Measure |
Dose Level A Glycopyrrolate (85 μg)
n=39 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level B Glycopyrrolate (42.5 μg)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level C Glycopyrrolate (14 μg)
n=41 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level D (Placebo)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
|---|---|---|---|---|
|
Change From Average Baseline FEV1 to Average FEV1 AUC0-4h Measured After First Dose
|
0.1377 Liters
Standard Error 0.01498
|
0.1027 Liters
Standard Error 0.01507
|
0.0859 Liters
Standard Error 0.01405
|
0.0000 Liters
Standard Error 0.01439
|
SECONDARY outcome
Timeframe: From first dose through the follow-up contact (approximately 8 weeks per participant). Overall safety data was collected for 5 months total.Outcome measures
| Measure |
Dose Level A Glycopyrrolate (85 μg)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level B Glycopyrrolate (42.5 μg)
n=40 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level C Glycopyrrolate (14 μg)
n=41 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level D (Placebo)
n=43 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
|---|---|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs)
|
13 Events
|
8 Events
|
7 Events
|
15 Events
|
SECONDARY outcome
Timeframe: After morning dose Day 7Population: Placebo was excluded from the PK concentration listings.
Outcome measures
| Measure |
Dose Level A Glycopyrrolate (85 μg)
n=22 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level B Glycopyrrolate (42.5 μg)
n=22 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level C Glycopyrrolate (14 μg)
n=19 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level D (Placebo)
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
|---|---|---|---|---|
|
Glycopyrronium Free Base AUC0-12h
|
256 h*pg/mL
Standard Deviation 187.7
|
108 h*pg/mL
Standard Deviation 66.22
|
38.4 h*pg/mL
Standard Deviation 18.25
|
—
|
SECONDARY outcome
Timeframe: After morning dose Day 7Population: Placebo was excluded from the PK concentration listings.
Outcome measures
| Measure |
Dose Level A Glycopyrrolate (85 μg)
n=22 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level B Glycopyrrolate (42.5 μg)
n=22 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level C Glycopyrrolate (14 μg)
n=19 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level D (Placebo)
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
|---|---|---|---|---|
|
Glycopyrronium Free Base Maximum Plasma Drug Concentration (Cmax)
|
53.7 pg/mL
Standard Deviation 38.46
|
24.7 pg/mL
Standard Deviation 13.87
|
9.27 pg/mL
Standard Deviation 5.354
|
—
|
SECONDARY outcome
Timeframe: After morning dose Day 7Population: Placebo was excluded from the PK concentration listings.
Outcome measures
| Measure |
Dose Level A Glycopyrrolate (85 μg)
n=22 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level B Glycopyrrolate (42.5 μg)
n=22 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level C Glycopyrrolate (14 μg)
n=19 Participants
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level D (Placebo)
The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
|---|---|---|---|---|
|
Glycopyrronium Free Base Time to Maximum Plasma Drug Concentration (Tmax)
|
0.33 hours
Interval 0.0 to 1.63
|
0.33 hours
Interval 0.0 to 0.77
|
0.43 hours
Interval 0.25 to 1.25
|
—
|
Adverse Events
Dose Level A Glycopyrrolate (85 μg)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Level B Glycopyrrolate (42.5 μg)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Level C Glycopyrrolate (14 μg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Level D (Placebo)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level A Glycopyrrolate (85 μg)
n=40 participants at risk
The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level B Glycopyrrolate (42.5 μg)
n=40 participants at risk
The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level C Glycopyrrolate (14 μg)
n=41 participants at risk
The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
Dose Level D (Placebo)
n=43 participants at risk
The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days
|
|---|---|---|---|---|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
2.5%
1/40 • Adverse event data was collected over a 5-month period, however individual participant data was collected only for 8 weeks
Adverse events are assessed at every participant visit and end of study follow up call
|
0.00%
0/40 • Adverse event data was collected over a 5-month period, however individual participant data was collected only for 8 weeks
Adverse events are assessed at every participant visit and end of study follow up call
|
0.00%
0/41 • Adverse event data was collected over a 5-month period, however individual participant data was collected only for 8 weeks
Adverse events are assessed at every participant visit and end of study follow up call
|
0.00%
0/43 • Adverse event data was collected over a 5-month period, however individual participant data was collected only for 8 weeks
Adverse events are assessed at every participant visit and end of study follow up call
|
|
Injury, poisoning and procedural complications
INJURY
|
0.00%
0/40 • Adverse event data was collected over a 5-month period, however individual participant data was collected only for 8 weeks
Adverse events are assessed at every participant visit and end of study follow up call
|
2.5%
1/40 • Adverse event data was collected over a 5-month period, however individual participant data was collected only for 8 weeks
Adverse events are assessed at every participant visit and end of study follow up call
|
0.00%
0/41 • Adverse event data was collected over a 5-month period, however individual participant data was collected only for 8 weeks
Adverse events are assessed at every participant visit and end of study follow up call
|
0.00%
0/43 • Adverse event data was collected over a 5-month period, however individual participant data was collected only for 8 weeks
Adverse events are assessed at every participant visit and end of study follow up call
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
5.0%
2/40 • Adverse event data was collected over a 5-month period, however individual participant data was collected only for 8 weeks
Adverse events are assessed at every participant visit and end of study follow up call
|
0.00%
0/40 • Adverse event data was collected over a 5-month period, however individual participant data was collected only for 8 weeks
Adverse events are assessed at every participant visit and end of study follow up call
|
0.00%
0/41 • Adverse event data was collected over a 5-month period, however individual participant data was collected only for 8 weeks
Adverse events are assessed at every participant visit and end of study follow up call
|
2.3%
1/43 • Adverse event data was collected over a 5-month period, however individual participant data was collected only for 8 weeks
Adverse events are assessed at every participant visit and end of study follow up call
|
Other adverse events
Adverse event data not reported
Additional Information
Verona Pharma Clinical Trials
Verona Pharma plc
Phone: Please reach out by email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place