Trial Outcomes & Findings for A Clinical Study to Investigate if a Single Dose of an Approved Drug Product (Glycopyrrolate Inhalation Solution) Reduces Trapped Air in the Lungs of Participants With Chronic Obstructive Pulmonary Disease. (NCT NCT04155047)
NCT ID: NCT04155047
Last Updated: 2021-05-10
Results Overview
Change from baseline in Residual Volume (Residual Volume is defined as the volume of gas that remains in lungs after maximal exhalation) at 6 hours postdose.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
6 hours post dose
Results posted on
2021-05-10
Participant Flow
There were 44 subjects enrolled in the study. There were 22 subjects that screen failed and did not participate in the study. There were 22 subjects that started the study.
Participant milestones
| Measure |
Glycopyrrolate Inhalation Solution (GIS) First, Then Placebo Inhalation Solution (PIS)
Treatment sequence AB: Single dose of GIS 25 mcg (Treatment A) to matching PIS (Treatment B)
|
Placebo Inhalation Solution (PIS) First, Then Glycopyrrolate Inhalation Solution (GIS)
Treatment sequence BA: Matching PIS (Treatment B) to single dose of GIS 25 mcg (Treatment A)
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Glycopyrrolate Inhalation Solution (GIS) First, Then Placebo Inhalation Solution (PIS)
Treatment sequence AB: Single dose of GIS 25 mcg (Treatment A) to matching PIS (Treatment B)
|
Placebo Inhalation Solution (PIS) First, Then Glycopyrrolate Inhalation Solution (GIS)
Treatment sequence BA: Matching PIS (Treatment B) to single dose of GIS 25 mcg (Treatment A)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
COVID-19: SUBJECT REFUSED STUDY VISITS DUE TO COVID-19 THREAT
|
1
|
0
|
Baseline Characteristics
Among the 11 participants in treatment sequence AB, 2 participants received Treatment A (GIS 25mcg) in period 1 and did not continue into period 2. Therefore, there were only 9 participants with baseline measures for Treatment B (PIS).
Baseline characteristics by cohort
| Measure |
Glycopyrrolate Inhalation Solution (GIS) First, Then Placebo Inhalation Solution (PIS)
n=11 Participants
Treatment sequence AB: Single dose of GIS 25 mcg (Treatment A) to matching PIS (Treatment B)
|
Placebo Inhalation Solution (PIS) First, Then Glycopyrrolate Inhalation Solution (GIS)
n=11 Participants
Treatment sequence BA: Matching PIS (Treatment B) to single dose of GIS 25 mcg (Treatment A)
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
12 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=11 Participants
|
6 Participants
n=11 Participants
|
10 Participants
n=22 Participants
|
|
Age, Continuous
|
65.4 Years
STANDARD_DEVIATION 8.03 • n=11 Participants
|
66.5 Years
STANDARD_DEVIATION 8.12 • n=11 Participants
|
65.9 Years
STANDARD_DEVIATION 7.9 • n=22 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
12 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=11 Participants
|
6 Participants
n=11 Participants
|
10 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
22 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
22 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Weight (kg)
|
96.69 kg
STANDARD_DEVIATION 22.683 • n=11 Participants
|
92.65 kg
STANDARD_DEVIATION 23.808 • n=11 Participants
|
94.67 kg
STANDARD_DEVIATION 22.785 • n=22 Participants
|
|
Height (cm)
|
166.4 cm
STANDARD_DEVIATION 12.18 • n=11 Participants
|
175.1 cm
STANDARD_DEVIATION 8.94 • n=11 Participants
|
170.8 cm
STANDARD_DEVIATION 11.33 • n=22 Participants
|
|
BMI (kg/m^2)
|
34.67 kg/m^2
STANDARD_DEVIATION 6.131 • n=11 Participants
|
30.14 kg/m^2
STANDARD_DEVIATION 7.086 • n=11 Participants
|
32.4 kg/m^2
STANDARD_DEVIATION 6.87 • n=22 Participants
|
|
Baseline Residual Volume for GIS 25 mcg
|
3.132 L
STANDARD_DEVIATION 0.5631 • n=11 Participants
|
3.696 L
STANDARD_DEVIATION 0.7570 • n=11 Participants
|
3.414 L
STANDARD_DEVIATION 0.7123 • n=22 Participants
|
|
Baseline Residual Volume for Placebo
|
3.174 L
STANDARD_DEVIATION 0.5669 • n=9 Participants • Among the 11 participants in treatment sequence AB, 2 participants received Treatment A (GIS 25mcg) in period 1 and did not continue into period 2. Therefore, there were only 9 participants with baseline measures for Treatment B (PIS).
|
3.592 L
STANDARD_DEVIATION 0.6915 • n=11 Participants • Among the 11 participants in treatment sequence AB, 2 participants received Treatment A (GIS 25mcg) in period 1 and did not continue into period 2. Therefore, there were only 9 participants with baseline measures for Treatment B (PIS).
|
3.404 L
STANDARD_DEVIATION 0.6575 • n=20 Participants • Among the 11 participants in treatment sequence AB, 2 participants received Treatment A (GIS 25mcg) in period 1 and did not continue into period 2. Therefore, there were only 9 participants with baseline measures for Treatment B (PIS).
|
PRIMARY outcome
Timeframe: 6 hours post dosePopulation: Efficacy Population : all subjects who were randomized, received at least one dose of study treatment, and have a baseline and at least one post-baseline RV measurement within the same period.
Change from baseline in Residual Volume (Residual Volume is defined as the volume of gas that remains in lungs after maximal exhalation) at 6 hours postdose.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo Inhalation Solution (PIS) administered by Magair
|
GIS 25 mcg Single Dose
n=22 Participants
Glycopyrrolate Inhalation Solution (GIS) 25 mcg administered by Magnair
|
|---|---|---|
|
Change From Baseline in Residual Volume (RV) at 6 Hours Postdose
|
0.004 L
Standard Error 0.1392
|
-0.319 L
Standard Error 0.1313
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GIS 25 mcg Single Dose
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 |
Placebo
n=20 participants at risk
Placebo Inhalation Solution (PIS) administered by Magair
|
GIS 25 mcg Single Dose
n=22 participants at risk
Glycopyrrolate Inhalation Solution (GIS) 25 mcg administered by Magnair
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/20 • 2 weeks
|
4.5%
1/22 • Number of events 1 • 2 weeks
|
Additional Information
Respiratory Medical Director
Sunovion Respiratory Development Inc.
Phone: 1-866-503-6351
Email: [email protected]
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