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Trial record 27 of 186 for:    GLYCOPYRROLATE

Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02948582
Recruitment Status : Completed
First Posted : October 28, 2016
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Sunovion Respiratory Development Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Glycopyrrolate Inhalation Solution12.5μg
Drug: Glycopyrrolate Inhalation Solution 50μg
Drug: Glycopyrrolate Inhalation Solution 100μg
Drug: Glycopyrrolate Inhalation Solution 200μg
Drug: Glycopyrrolate Inhalation Solution 400μg
Drug: Placebo 0.5mL
Enrollment 42
Recruitment Details  
Pre-assignment Details All enrolled subjects were randomized. all randomized subjects received at least one dose of study medication
Arm/Group Title Treatment Group 1 Treatment Group 2 Treatment Group 3 Treatment Group 4 Treatment Group 5 Treatment Group 6
Hide Arm/Group Description subjects received placebo, glycopyrrolate 400mcg, glycopyrrolate 50 mcg, glycopyrrolate 12.5 mcg, glycoyrrolate 200mcg, or glycopryrrolate 100mcg subjects received glycopyrrolate 12.5 mcg, glycopyrrolate 50 mcg, glycopryrrolate 100mcg, placebo, glycopyrrolate 200mcg, glycoyrrolate 400mcg, or placebo subjects received glycopyrrolate 50 mcg, Placebo, glycopyrrolate 200 mcg, glycopryrrolate 100mcg, glycopyrrolate 12.5mcg, or glycoyrrolate 400mcg subjects received glycopyrrolate 100 mcg, glycopyrrolate 200 mcg, glycopryrrolate 400mcg, placebo, glycopyrrolate 50mcg, or glycoyrrolate 12.5mcg subjects received glycopyrrolate 200 mcg, glycopyrrolate 12.5 mcg, placebo, glycopryrrolate 400mcg, placebo, glycopyrrolate 100mcg, or glycoyrrolate 50mcg subjects received glycopyrrolate 400 mcg, glycopyrrolate 100 mcg, glycopryrrolate 12.5mcg, glycopyrrolate 50mcg, placebo or glycoyrrolate 200mcg
Period Title: Treatment Period 1
Started 7 7 7 7 7 7
Completed 7 7 7 7 7 7
Not Completed 0 0 0 0 0 0
Period Title: Washout Period 1
Started 7 7 7 7 7 7
Completed 7 5 7 7 7 6
Not Completed 0 2 0 0 0 1
Reason Not Completed
Adverse Event             0             2             0             0             0             0
Protocol Violation             0             0             0             0             0             1
Period Title: Treatment Period 2
Started 7 5 7 7 7 6
Completed 7 5 7 7 7 6
Not Completed 0 0 0 0 0 0
Period Title: Washout Period 2
Started 7 5 7 7 7 6
Completed 7 4 7 6 7 6
Not Completed 0 1 0 1 0 0
Reason Not Completed
Adverse Event             0             1             0             0             0             0
personal reasons             0             0             0             1             0             0
Period Title: Treatment Period 3
Started 7 4 7 6 7 6
Completed 7 4 7 6 7 6
Not Completed 0 0 0 0 0 0
Period Title: Washout Period 3
Started 7 4 7 6 7 6
Completed 7 4 7 6 7 6
Not Completed 0 0 0 0 0 0
Period Title: Treatment Period 4
Started 7 4 7 6 7 6
Completed 7 4 7 6 7 6
Not Completed 0 0 0 0 0 0
Period Title: Washout Period 4
Started 7 4 7 6 7 6
Completed 6 4 6 6 7 6
Not Completed 1 0 1 0 0 0
Reason Not Completed
Adverse Event             1             0             1             0             0             0
Period Title: Treatment Period 5
Started 6 4 6 6 7 6
Completed 6 4 6 6 7 6
Not Completed 0 0 0 0 0 0
Period Title: Washout Period 5
Started 6 4 6 6 7 6
Completed 6 4 6 6 7 6
Not Completed 0 0 0 0 0 0
Period Title: Treatment Period 6
Started 6 4 6 6 7 6
Completed 6 4 6 6 7 6
Not Completed 0 0 0 0 0 0
Period Title: Wshout Period 6
Started 6 4 6 6 7 6
Completed 6 4 6 6 7 6
Not Completed 0 0 0 0 0 0
Arm/Group Title Total Participants
Hide Arm/Group Description Intent to treat population same as safety population -not full analysis set
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
Intent to treat population same as safety population -not full analysis set
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
  69.0%
>=65 years
13
  31.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
62.0  (6.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
15
  35.7%
Male
27
  64.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
42
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
41
  97.6%
More than one race
1
   2.4%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United Kingdom Number Analyzed 42 participants
42
1.Primary Outcome
Title Trough FEV1 (Change From Baseline)
Hide Description

Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.

Trough FEV1 was defined as the mean of FEV1 values obtained at 23 hours 30 minutes and 24 hours post-dose of each Treatment Visit.

Time Frame 24hr post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent-to-treat analysis.
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Placebo 0.5mL via e-flow nebulizer, once daily

Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily

Overall Number of Participants Analyzed 38 38 37 37 37 37
Mean (Standard Deviation)
Unit of Measure: liters
-0.093  (0.1189) 0.0114  (0.1308) 0.0447  (0.1548) 0.0542  (0.1779) 0.0292  (0.1468) -0.0612  (0.1233)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glycopyrrolate Inhalation Solution12.5μg, Placebo 0.5mL
Comments

An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.

A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1257
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.033
Confidence Interval (2-Sided) 95%
-0.009 to 0.075
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glycopyrrolate Inhalation Solution 50μg, Placebo 0.5mL
Comments

An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.

A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.072
Confidence Interval (2-Sided) 95%
0.030 to 0.113
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Glycopyrrolate Inhalation Solution 100μg, Placebo 0.5mL
Comments

An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.

A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.102
Confidence Interval (2-Sided) 95%
0.061 to 0.144
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Glycopyrrolate Inhalation Solution 200μg, Placebo 0.5mL
Comments

An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.

A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.108
Confidence Interval (2-Sided) 95%
0.066 to 0.150
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Glycopyrrolate Inhalation Solution 400μg, Placebo 0.5mL
Comments

An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.

A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.098
Confidence Interval (2-Sided) 95%
0.056 to 0.140
Estimation Comments [Not Specified]
2.Primary Outcome
Title Standardized FEV1AUC0-12 Area Under the FEV1 Curve From 0 to 12 Hours Post-dose ( Actual and Change From Baseline).
Hide Description Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.. The standardized actual FEV1 AUC(0-12) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-12) was also calculated similarly, using the change from pre-dose FEV1.
Time Frame 0-12h post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Placebo 0.5mL via e-flow nebulizer, once daily

Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily

Overall Number of Participants Analyzed 39 38 37 37 37 37
Mean (Standard Deviation)
Unit of Measure: liters
actual standardized FEV1 AUC0_12 1.259  (0.409) 1.311  (0.422) 1.335  (0.394) 1.374  (0.391) 1.390  (0.423) 1.180  (0.427)
change from baseline standardized FEV1 AUC0_12 0.055  (0.113) 0.126  (0.112) 0.136  (0.134) 0.184  (0.134) 0.170  (0.110) -0.024  (0.095)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glycopyrrolate Inhalation Solution12.5μg, Placebo 0.5mL
Comments An analysis of covariance was used with change from baseline in standardized FEV1 AUC0_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.086
Confidence Interval (2-Sided) 95%
0.050 to 0.123
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glycopyrrolate Inhalation Solution 50μg, Placebo 0.5mL
Comments An analysis of covariance was used with change from baseline in standardized FEV1 AUC0_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.151
Confidence Interval (2-Sided) 95%
0.114 to 0.187
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Glycopyrrolate Inhalation Solution 100μg, Placebo 0.5mL
Comments An analysis of covariance was used with change from baseline in standardized FEV1 AUC0_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.156
Confidence Interval (2-Sided) 95%
0.120 to 0.193
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Glycopyrrolate Inhalation Solution 200μg, Placebo 0.5mL
Comments An analysis of covariance was used with change from baseline in standardized FEV1 AUC0_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.202
Confidence Interval (2-Sided) 95%
0.165 to 0.239
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Glycopyrrolate Inhalation Solution 400μg, Placebo 0.5mL
Comments An analysis of covariance was used with change from baseline in standardized FEV1 AUC0_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.199
Confidence Interval (2-Sided) 95%
0.162 to 0.235
Estimation Comments [Not Specified]
3.Primary Outcome
Title Standardized FEV1AUC12-24 Area Under the FEV1 Curve From 12 to 24 Hours Post- Dose (Actual and Change From Baseline).
Hide Description Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized actual FEV1 AUC(12-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(12-24) was also calculated similarly, using the change from pre-dose FEV1.
Time Frame 12-24h post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Placebo 0.5mL via e-flow nebulizer, once daily

Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily

Overall Number of Participants Analyzed 39 38 37 37 37 37
Mean (Standard Deviation)
Unit of Measure: liters
acutal standardized FEV1 AUC0_12 1.165  (0.377) 1.203  (0.404) 1.227  (0.369) 1.253  (0.346) 1.259  (0.396) 1.123  (0.392)
change from baseline standardized FEV1 AUC0_12 -0.038  (0.132) 0.018  (0.135) 0.028  (0.138) 0.063  (0.178) 0.039  (0.135) -0.082  (0.120)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glycopyrrolate Inhalation Solution12.5μg, Placebo 0.5mL
Comments An analysis of covariance was used with change from baseline in standardized FEV1 AUC12_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0028
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.058
Confidence Interval (2-Sided) 95%
0.021 to 0.095
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo 0.5mL
Comments An analysis of covariance was used with change from baseline in standardized FEV1 AUC12_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method least squares mena
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.100
Confidence Interval (2-Sided) 95%
0.063 to 0.137
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Glycopyrrolate Inhalation Solution 100μg, Placebo 0.5mL
Comments An analysis of covariance was used with change from baseline in standardized FEV1 AUC12_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.105
Confidence Interval (2-Sided) 95%
0.068 to 0.142
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Glycopyrrolate Inhalation Solution 200μg, Placebo 0.5mL
Comments An analysis of covariance was used with change from baseline in standardized FEV1 AUC12_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.135
Confidence Interval (2-Sided) 95%
0.098 to 0.173
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo 0.5mL
Comments An analysis of covariance was used with change from baseline in standardized FEV1 AUC12_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method least squares mean
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.128
Confidence Interval (2-Sided) 95%
0.091 to 0.166
Estimation Comments [Not Specified]
4.Primary Outcome
Title Standardized FEV1 AUC0-24 Area Under the FEV1 Curve From 0 to 24 Hours Post-dose (Actual and Change Baseline)
Hide Description Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The standardized actual FEV1 AUC(0-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-24) was also calculated similarly, using the change from pre-dose FEV1.
Time Frame 0 to 24h
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Placebo 0.5mL via e-flow nebulizer, once daily

Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily

Overall Number of Participants Analyzed 39 38 37 37 37 37
Mean (Standard Deviation)
Unit of Measure: liters
Actual standardized FEV1 AUC0_12 1.212  (0.391) 1.257  (0.411) 1.281  (0.379) 1.313  (0.364) 1.325  (0.407) 1.151  (0.408)
change from baseline standardized FEV1 AUC0_12 0.009  (0.114) 0.072  (0.115) 0.082  (0.128) 0.123  (0.146) 0.105  (0.113) -0.053  (0.102)
5.Primary Outcome
Title Peak FEV1 (Change From Baseline and Percent Change)
Hide Description spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The peak FEV1 was defined as the highest post-dose FEV1 value within 4 hrs after the dose. Percent change from baseline was calculated as 100 times the difference of peak FEV1 minus baseline FEV1 divided by baseline FEV1.
Time Frame 0-4h post dose
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Hide Analysis Population Description
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
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
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Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Placebo 0.5mL via e-flow nebulizer, once daily

Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily

Overall Number of Participants Analyzed 39 38 37 37 37 37
Mean (Standard Deviation)
Unit of Measure: liters
Change from baseline 0.165  (0.113) 0.229  (0.113) 0.260  (0.151) 0.292  (0.120) 0.272  (0.125) 0.061  (0.102)
percent change from baseline 15.30  (11.37) 21.05  (11.87) 24.14  (20.69) 26.73  (12.56) 25.44  (15.10) 5.24  (8275)
6.Secondary Outcome
Title Cmax; Maximum Observed Plasma Concentration
Hide Description Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Time Frame 0 to 12 hour
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Hide Analysis Population Description
All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg
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Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Overall Number of Participants Analyzed 2 13 12 12 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
59.25
(78.49%)
74.48
(62.24%)
144.58
(52.53%)
316.05
(48.35%)
504.93
(55.67%)
7.Secondary Outcome
Title Tmax; Time to Maximum Observed Plasma Concentration
Hide Description Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Time Frame 0 to 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Overall Number of Participants Analyzed 2 13 12 12 12
Median (Full Range)
Unit of Measure: hours
0.165
(0.150 to 0.180)
0.320
(.0150 to 0.350)
0.260
(0.150 to 0.330)
0.275
(0.150 to 0.380)
0.180
(0.150 to 0.320)
8.Secondary Outcome
Title t1/2; Plasma Half-life
Hide Description Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Time Frame 0 to 12 hour
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Overall Number of Participants Analyzed 0 2 4 7 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
0.8949
(2.3707%)
3.0137
(50.7557%)
3.1663
(45.4839%)
4.1238
(63.5353%)
9.Secondary Outcome
Title AUC0-t; Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Drug Concentration.
Hide Description Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Time Frame 0 to 12 hour
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Overall Number of Participants Analyzed 2 13 12 12 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg.h/ml
135.87
(209.27%)
67.18
(143.22%)
237.80
(98.45%)
677.24
(66.34%)
1481.36
(82.17%)
10.Secondary Outcome
Title AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity
Hide Description Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Time Frame 0 to 12 hour
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Overall Number of Participants Analyzed 0 2 4 7 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg.h/ml
246.84
(37.49%)
634.65
(34.28%)
772.59
(26.30%)
1367.76
(76.70%)
11.Secondary Outcome
Title Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE
Hide Description AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
Time Frame Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects who received at least one dose of study drug were included in the safety analysis
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Placebo 0.5mL via e-flow nebulizer, once daily

Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily

Overall Number of Participants Analyzed 39 38 37 37 37 37
Measure Type: Number
Unit of Measure: participants
subjects who died 0 0 0 0 0 0
subjects with treatment emergent SAEs 0 0 1 0 0 0
Subjects whodiscontinued due to an AE 2 2 2 0 0 0
subjects with treatment emergent AEs 16 14 17 15 13 14
12.Secondary Outcome
Title Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study
Hide Description Vital signs were measured at screening and at each Treatment Visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment.
Time Frame 0-24 h
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects who received at least one does of study drug were included in the safety analysis
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Placebo 0.5mL via e-flow nebulizer, once daily

Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily

Overall Number of Participants Analyzed 39 38 37 37 37 37
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Clinically Significant Abnormal Laboratory Results Reported During the Study
Hide Description Clinical safety lab parameters were collected at screening and at the post study assessment. Any laboratory values that were out of range of normal reference values were evaluated by the Investigators.
Time Frame Day -14, Day 69
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects who received at least one dose of study drug were included in the safety analysis
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Placebo 0.5mL via e-flow nebulizer, once daily

Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily

Overall Number of Participants Analyzed 39 38 37 37 37 37
Measure Type: Number
Unit of Measure: number of events
0 0 0 0 0 0
14.Secondary Outcome
Title Number of Subjects With Clinically Significant ECG Parameters Reported During the Study
Hide Description ECGs were recorded at screening and at each study treatment visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment.
Time Frame 0 to 24h
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects who received at least one dose of study drug were included in the safety analysis
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Placebo 0.5mL via e-flow nebulizer, once daily

Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily

Overall Number of Participants Analyzed 39 38 37 37 37 37
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0 0 0 0
15.Secondary Outcome
Title Percentage of Subjects With Treatment Emergent AEs
Hide Description AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
Time Frame Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects who received at least one dose of study drug were included in the safety analysis
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Placebo 0.5mL via e-flow nebulizer, once daily

Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily

Overall Number of Participants Analyzed 39 38 37 37 37 37
Measure Type: Number
Unit of Measure: percentage of participants
41.0 36.8 45.9 40.5 35.1 37.8
Time Frame 0-69 days
Adverse Event Reporting Description AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
 
Arm/Group Title Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
Hide Arm/Group Description

Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily

Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

Placebo 0.5mL via e-flow nebulizer, once daily

Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily

All-Cause Mortality
Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      0/38 (0.00%)      1/37 (2.70%)      0/37 (0.00%)      0/37 (0.00%)      0/37 (0.00%)    
General disorders             
groin pain  1  0/39 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  2 0/37 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glycopyrrolate Inhalation Solution12.5μg Glycopyrrolate Inhalation Solution 50μg Glycopyrrolate Inhalation Solution 100μg Glycopyrrolate Inhalation Solution 200μg Glycopyrrolate Inhalation Solution 400μg Placebo 0.5mL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/39 (33.33%)      9/38 (23.68%)      10/37 (27.03%)      10/37 (27.03%)      10/37 (27.03%)      10/37 (27.03%)    
Injury, poisoning and procedural complications             
skin injury  1  0/39 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0 2/37 (5.41%)  2
Nervous system disorders             
headache  1  6/39 (15.38%)  7 5/38 (13.16%)  6 5/37 (13.51%)  8 7/37 (18.92%)  9 6/37 (16.22%)  8 4/37 (10.81%)  5
Respiratory, thoracic and mediastinal disorders             
chronic obstructive pulmonary disease  1  2/39 (5.13%)  2 1/38 (2.63%)  1 0/37 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
cough  1  3/39 (7.69%)  3 2/38 (5.26%)  2 5/37 (13.51%)  5 3/37 (8.11%)  3 3/37 (8.11%)  4 5/37 (13.51%)  5
dyspnoea  1  3/39 (7.69%)  3 2/38 (5.26%)  2 1/37 (2.70%)  1 1/37 (2.70%)  2 1/37 (2.70%)  1 2/37 (5.41%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Respiratory Medical Director
Organization: Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
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Responsible Party: Sunovion Respiratory Development Inc.
ClinicalTrials.gov Identifier: NCT02948582     History of Changes
Other Study ID Numbers: EP-101-02
2010-018987-17 ( EudraCT Number )
First Submitted: October 26, 2016
First Posted: October 28, 2016
Results First Submitted: January 2, 2018
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018