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Pharmacokinetic, Safety, Tolerability, and Clinical Effect of Topical Umeclidinium in Primary Axillary Hyperhidrosis

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ClinicalTrials.gov Identifier: NCT02563899
Recruitment Status : Completed
First Posted : September 30, 2015
Results First Posted : November 17, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hyperhidrosis
Interventions Drug: Umeclidinium
Drug: Vehicle
Enrollment 28
Recruitment Details The study conducted between 23 November 2015 to 25 February 2016. The data for population pharmacokinetic (PK) analysis was pooled from the earlier two studies including LHH117157 (NCT01934153) (6 participants from Cohort B) and AC4112008 (NCT01110018) (9 participants) with the data of the current study.
Pre-assignment Details A total of 28 participants randomized in this study. Because of a system configuration error, randomization numbers were assigned to 5 screen failure participants. However, these participants did not enter the study and not dosed, remaining 23 participants (18- Umeclidinium; 5- Placebo) included in Full Analysis Population.
Arm/Group Title 202093: Umeclidinium, 2 mg/cm^2 of 1.85%, OD 202093: Vehicle AC4112008: GSK573719 LHH117157: Cohort B
Hide Arm/Group Description Participants topically applied Umeclidinium 2 milligram per square centimeter (mg/cm^2) of the 1.85%, administered once daily (OD) to both axillae, at night before going to bed for 14 days. Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days. Each participant received single dose of treatment in the following order of intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. The washout was of 5 days between two consecutive periods. A single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% weight/ weight (w/w) solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 centimeter squared (cm^2) surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg).
Period Title: Overall Study
Started 18 5 10 6
Completed 17 5 9 6
Not Completed 1 0 1 0
Reason Not Completed
Protocol Violation             1             0             0             0
Withdrawal by Subject             0             0             1             0
Arm/Group Title 202093: Umeclidinium, 2 mg/cm^2 of 1.85%, OD 202093: Vehicle AC4112008: GSK573719 LHH117157: Cohort B Total
Hide Arm/Group Description Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days. Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days. Each participant received single dose of treatment in the following order of intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. The washout was of 5 days between two consecutive periods. A single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% (w/w) solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 (cm^2) surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg). Total of all reporting groups
Overall Number of Baseline Participants 18 5 10 6 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
19 to 64 Years Number Analyzed 18 participants 5 participants 10 participants 6 participants 39 participants
18
 100.0%
5
 100.0%
10
 100.0%
6
 100.0%
39
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 5 participants 10 participants 6 participants 39 participants
Female
9
  50.0%
4
  80.0%
0
   0.0%
0
   0.0%
13
  33.3%
Male
9
  50.0%
1
  20.0%
10
 100.0%
6
 100.0%
26
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 5 participants 10 participants 6 participants 39 participants
Hispanic or Latino
0
   0.0%
2
  40.0%
0
   0.0%
0
   0.0%
2
   5.1%
Not Hispanic or Latino
18
 100.0%
3
  60.0%
10
 100.0%
6
 100.0%
37
  94.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Mean Plasma Concentration After Repeat Dosing of Umeclidinium
Hide Description Pharmacokinetic blood sampling was done at the following time points: Day 12 (pre-dose), Day 13 (pre-dose), Day 14 (pre-dose), Day 15 (3 hours [h], 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Approximately 3 ml of blood was taken at each timepoint. Mean and standard deviation of the umeclidinium concentration was reported. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Day 12 to Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Population defined as all participants in the Safety population for whom at least one pharmacokinetic sample was obtained and analyzed. Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093)
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: picogram per millilitre (pg/ml)
DAY 12, Pre-dose Number Analyzed 12 participants
33.09  (23.206)
DAY 13, Pre-dose Number Analyzed 13 participants
29.86  (20.981)
DAY 14, Pre-dose Number Analyzed 15 participants
41.22  (42.465)
Day 14, 3 h Number Analyzed 16 participants
42.72  (57.839)
Day 14, 6 h Number Analyzed 16 participants
53.68  (69.157)
Day 14, 9 h Number Analyzed 16 participants
57.32  (74.719)
Day 14, 10 h Number Analyzed 16 participants
57.24  (77.945)
Day 14, 12 h Number Analyzed 15 participants
50.72  (63.468)
Day 14, 16 h Number Analyzed 16 participants
35.42  (37.727)
Day 14, 24 h Number Analyzed 16 participants
31.50  (29.458)
Day 14, 36 h Number Analyzed 16 participants
30.76  (46.979)
Day 14, 48 h Number Analyzed 16 participants
14.28  (14.739)
2.Primary Outcome
Title Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) After Repeat Dosing of Umeclidinium
Hide Description Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Cmax and Ctau was determined directly from the concentration-time data.
Time Frame Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
Cmax, Day 14 Number Analyzed 16 participants
44.79
(175.27%)
Ctau, Day 12 Number Analyzed 12 participants
27.94
(63.30%)
Ctau, Day 13 Number Analyzed 13 participants
25.81
(55.40%)
Ctau, Day 14 Number Analyzed 12 participants
39.60
(87.68%)
Ctau, Day 15 Number Analyzed 14 participants
29.63
(66.76%)
3.Primary Outcome
Title Mean Time to Reach Cmax (Tmax) of Umeclidinium After Repeat Dosing
Hide Description Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Tmax was determined directly from the concentration-time data.
Time Frame Day 14 to Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: h
10.25  (7.985)
4.Primary Outcome
Title Mean Terminal Plasma Elimination Rate Constant (Lambda Z) of Umeclidinium After Repeat Dosing
Hide Description Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Derivation of lambda-Z was planned. However, the parameter could not be derived for any of the participant included in the study because of insufficient data in the elimination phase (< 3 data points, coefficient of determination (R^2) was not adequate).
Time Frame Day 14 to Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Population
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Primary Outcome
Title Terminal Phase Half-life (t1/2) of Umeclidinium After Repeat Dosing
Hide Description Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Derivation of t1/2 was planned. However, the parameter could not be derived for any of the participant included in the study because of insufficient data in the elimination phase (< 3 data points, coefficient of determination (R^2) was not adequate).
Time Frame Day 14 to Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Population
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Mean Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Across All Treatments (0-t) and AUC Over the Dosing Interval (0-tau) of Umeclidinium After Repeat Dosing
Hide Description Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. Geometric mean of log-transformed values of AUC were reported.
Time Frame Day 14 to Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
AUC(0-t)
1036.90
(142.63%)
AUC(0-tau)
703.67
(108.61%)
7.Primary Outcome
Title Composite Population Pharmacokinetics Parameter: Volume of Distribution in Central Compartment (V1) and Volume of Distribution in Peripheral Compartment (V2)
Hide Description Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for V1 and V2 was reported as mean (estimate) with relative standard error (RSE). RSE= (Standard error of the estimate/ Final parameter estimate) X 100.
Time Frame Day 12 to Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population Pk parameter analysis.
Arm/Group Title Pooled Umeclidinium Population PK Arm
Hide Arm/Group Description:
This arm is consisted of pooled PK populations from study 202093, AC4112008 and LHH117157. In the study 202093 participants topically applied Umeclidinium 2 mg/cm^2 of 1.85%, administered OD to both axillae, at night before going to bed for 14 days. In the study AC411200 each participant received single dose of treatment in the following of order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. Washout was of 5 days between two consecutive periods. In the study LHH117157 a single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% w/w solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 cm^2 surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg)
Overall Number of Participants Analyzed 31
Mean (Standard Error)
Unit of Measure: Litre (L)
V1 7.44  (9.65)
V2 333  (22.6)
8.Primary Outcome
Title Composite Population Pharmacokinetics Parameter: Elimination Clearance (CL) and Inter-compartmental Clearance (Q)
Hide Description Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for CL and Q was reported as mean (estimate) with RSE. RSE= (Standard error of the estimate/ Final parameter estimate) X 100.
Time Frame Day 12 to Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population Pk parameter analysis.
Arm/Group Title Pooled Umeclidinium Population PK Arm
Hide Arm/Group Description:
This arm is consisted of pooled PK populations from study 202093, AC4112008 and LHH117157. In the study 202093 participants topically applied Umeclidinium 2 mg/cm^2 of 1.85%, administered OD to both axillae, at night before going to bed for 14 days. In the study AC411200 each participant received single dose of treatment in the following of order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. Washout was of 5 days between two consecutive periods. In the study LHH117157 a single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% w/w solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 cm^2 surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg)
Overall Number of Participants Analyzed 31
Mean (Standard Error)
Unit of Measure: L/h
CL 53.2  (11.1)
Q 43.1  (24.6)
9.Primary Outcome
Title Composite Population Pharmacokinetics Parameter: Absorption Rate Constant (Ka)
Hide Description Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for Ka was reported as mean (estimate) with RSE. RSE= (Standard error of the estimate/ Final parameter estimate) X 100.
Time Frame Day 12 to Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population Pk parameter analysis.
Arm/Group Title Pooled Umeclidinium Population PK Arm
Hide Arm/Group Description:
This arm is consisted of pooled PK populations from study 202093, AC4112008 and LHH117157. In the study 202093 participants topically applied Umeclidinium 2 mg/cm^2 of 1.85%, administered OD to both axillae, at night before going to bed for 14 days. In the study AC411200 each participant received single dose of treatment in the following of order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. Washout was of 5 days between two consecutive periods. In the study LHH117157 a single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% w/w solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 cm^2 surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg)
Overall Number of Participants Analyzed 31
Mean (Standard Error)
Unit of Measure: 1/h
0.012  (48.6)
10.Primary Outcome
Title Composite Population Pharmacokinetics Parameter: Absolute Plasma Bioavailability Following Administration to Axilae (FA) Fraction of the Bioavailable Drug Absorbed Through a Zero Order Process (F2 [FIXED])
Hide Description Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for FA and F2 (FIXED) was reported as mean (estimate) with RSE. RSE= (Standard error of the estimate/ Final parameter estimate) x 100.
Time Frame Day 12 to Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population PK parameter analysis.
Arm/Group Title Pooled Umeclidinium Population PK Arm
Hide Arm/Group Description:
This arm is consisted of pooled PK populations from study 202093, AC4112008 and LHH117157. In the study 202093 participants topically applied Umeclidinium 2 mg/cm^2 of 1.85%, administered OD to both axillae, at night before going to bed for 14 days. In the study AC411200 each participant received single dose of treatment in the following of order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. Washout was of 5 days between two consecutive periods. In the study LHH117157 a single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% w/w solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 cm^2 surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg)
Overall Number of Participants Analyzed 31
Mean (Standard Error)
Unit of Measure: Ratio
FA -5.05  (3.15)
F2 -2  (0)
11.Primary Outcome
Title Composite Population Pharmacokinetics Parameter: Duration of the Zero Order Process and Lag Time for the First Order Absorption Process (ALAG1)
Hide Description Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for ALAG1 was reported as mean (estimate) with RSE. RSE= (Standard error of the estimate/ Final parameter estimate) x 100.
Time Frame Day 12 to Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population PK parameter analysis.
Arm/Group Title Pooled Umeclidinium Population PK Arm
Hide Arm/Group Description:
This arm is consisted of pooled PK populations from study 202093, AC4112008 and LHH117157. In the study 202093 participants topically applied Umeclidinium 2 mg/cm^2 of 1.85%, administered OD to both axillae, at night before going to bed for 14 days. In the study AC411200 each participant received single dose of treatment in the following of order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. Washout was of 5 days between two consecutive periods. In the study LHH117157 a single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% w/w solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 cm^2 surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg)
Overall Number of Participants Analyzed 31
Mean (Standard Error)
Unit of Measure: h
2.56  (26.5)
12.Primary Outcome
Title Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE)
Hide Description AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time Frame Over a period of 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of study number 202093, LHH117157 (Cohort B) and AC4112008 were used to report AEs.
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vehicle AC4112008: GSK573719 LHH117157: Cohort B
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
Each participants received single dose of treatment in the following order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. The washout was of 5 days between two consecutive periods.
A single dose of topically applied [14C] umeclidinium administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% (w/w) solution Umeclidinium (equivalent to a 2.2% Umeclidinium bromide solution) applied to 40 (cm^2) surface area of occluded axilla (resulting in a calculated net amount of active Umeclidinium of 3.06 mg).
Overall Number of Participants Analyzed 18 5 10 6
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
9
  50.0%
2
  40.0%
6
  60.0%
2
  33.3%
Any SAE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
13.Primary Outcome
Title Number of Participants With Abnormal Values of Potential Clinical for Electrocardiogram (ECG)
Hide Description Single 12-lead ECGs was obtained at Day 1, Day 14 and Day 28 during the study. The standard ECG criteria of potential clinical importance were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) absolute PR Interval, <110 msec, 3) absolute QRS Interval, < 75 msec and 4) increase from baseline in QTc > 60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vehicle
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 18 5
Measure Type: Count of Participants
Unit of Measure: Participants
Low QRS
3
  16.7%
0
   0.0%
High QRS
2
  11.1%
0
   0.0%
High QTcB
1
   5.6%
1
  20.0%
Low PR interval
0
   0.0%
1
  20.0%
14.Primary Outcome
Title Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance at Any Time on Treatment
Hide Description The clinical chemistry parameters analyzed were albumin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, bicarbonate, blood urea nitrogen, calcium, chloride, creatinine, gamma glutamyl transferase, glucose, potassium, sodium, total and direct bilirubin, total protein, uric acid. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important clinical chemistry findings at any visit were reported.
Time Frame Up to day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vehicle
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 18 5
Measure Type: Count of Participants
Unit of Measure: Participants
High, alanine aminotransferase
1
   5.6%
1
  20.0%
High, aspartate aminotransferase
1
   5.6%
1
  20.0%
High, glucose
1
   5.6%
1
  20.0%
15.Primary Outcome
Title Number of Participants With Clinical Hematology Abnormalities of Potential Clinical Importance at Any Time on Treatment.
Hide Description The hematology parameters analyzed were basophils, eosinophils, erythrocyte mean corpuscular hemoglobin concentration, erythrocyte mean corpuscular hemoglobin, erythrocyte mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets, and reticulocytes. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important hematology findings at any visit were reported.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vehicle
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 18 5
Measure Type: Count of Participants
Unit of Measure: Participants
Low, Neutrophils
1
   5.6%
0
   0.0%
High, Hematocrit
1
   5.6%
0
   0.0%
16.Primary Outcome
Title Number of Participants With Urinalysis Abnormalities of Potential Clinical Importance at Any Time on Treatment
Hide Description The urinalysis parameters analyzed were specific gravity, pH, glucose, protein, blood and ketones by dipstick, microscopic examination. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important urinalysis findings at any visit were reported.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vehicle
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 18 5
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
0
   0.0%
17.Primary Outcome
Title Number of Participants With Abnormal Values of Potential Clinical for Vital Signs
Hide Description The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vehicle
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 18 5
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
0
   0.0%
18.Primary Outcome
Title Number of Participants With Local Tolerability Assessment Score Over 28 Days
Hide Description The investigator or designated evaluator assessed skin tolerability at each visit using the 5-point tolerability scale. Tolerability of the topical application was assessed and scored as, 0- none (no evidence of local intolerance), 1-mild (minimal erythema and/or edema, slight glazed appearance), 2-moderate (definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology), 3-severe (erythema, edema glazing with fissures, few vesicles or papules), 4- very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions).
Time Frame Days 1, 2, 4, 5, 6, 7, 8, 9, 10, 13, 14, 15, 16, and 23
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vehicle
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 18 5
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1, Mild, n= 18, 5 Number Analyzed 18 participants 5 participants
2
  11.1%
0
   0.0%
Day 2, Mild, n= 18, 5 Number Analyzed 18 participants 5 participants
2
  11.1%
2
  40.0%
Day 4, Moderate, n= 18, 5 Number Analyzed 18 participants 5 participants
1
   5.6%
0
   0.0%
Day 5, Mild, n= 17, 5 Number Analyzed 17 participants 5 participants
2
  11.8%
0
   0.0%
Day 6, Mild, n= 17, 5 Number Analyzed 17 participants 5 participants
2
  11.8%
1
  20.0%
Day 7, Mild, n= 18, 5 Number Analyzed 18 participants 5 participants
2
  11.1%
0
   0.0%
Day 8, Mild, n= 15, 5 Number Analyzed 15 participants 5 participants
3
  20.0%
0
   0.0%
Day 9, Mild, n= 16, 5 Number Analyzed 16 participants 5 participants
1
   6.3%
0
   0.0%
Day 10, Mild, n= 16, 5 Number Analyzed 16 participants 5 participants
0
   0.0%
1
  20.0%
Day 13, Mild, n= 17, 5 Number Analyzed 17 participants 5 participants
2
  11.8%
1
  20.0%
Day 13, Moderate, n= 17, 5 Number Analyzed 17 participants 5 participants
1
   5.9%
0
   0.0%
Day 14, Mild, n= 17, 5 Number Analyzed 17 participants 5 participants
2
  11.8%
0
   0.0%
Day 15, Mild, n= 17, 5 Number Analyzed 17 participants 5 participants
1
   5.9%
0
   0.0%
Day 16, Mild, n= 17, 5 Number Analyzed 17 participants 5 participants
1
   5.9%
1
  20.0%
Day 23, Mild, n= 17, 5 Number Analyzed 17 participants 5 participants
2
  11.8%
0
   0.0%
19.Secondary Outcome
Title Change From Baseline in Amount of Sweat Produced at Day 15
Hide Description Amount of sweat produced was determined by gravimetry analysis for axilla. Filter paper in a sealed container was weighed. After drying the axillary surface, the filter paper was removed from the container and applied to the axilla. The paper was covered with plastic wrap and tape around the edges with paper tape. The filter paper was left in contact with the axilla for a period of 5 minutes as measured by a stopwatch. The filter paper was then replaced in the sealed container and re-weighed. Rate of sweat production was calculated in milligrams/minute (mg/min). Participants remained at rest for 20-30 minute before the measurements in order to reduce external interference. Measurements were carried out in a climate-controlled environment (21-24°C). Assessments conducted at Day 1, Pre-dose time point (average pre-dose measurements for both left and right measurements) were considered as Baseline values. Change from baseline was calculated as Day 15 value minus Baseline value.
Time Frame Baseline (Pre-dose, Day 1) and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis population comprised of participants receiving study medication and having at least 1 post baseline visit. Only those participants available at the specified time points were analyzed.
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vehicle
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 17 5
Mean (Standard Deviation)
Unit of Measure: mg/ min
-0.0571  (0.09402) -0.0164  (0.01735)
20.Secondary Outcome
Title Percentage of Participants With Cut-points for Percent Change From Baseline in Sweat Production at Day 15
Hide Description Amount of sweat produced was determined by gravimetry analysis for axilla. Filter paper in a sealed container was weighed. After drying the axillary surface, the filter paper was removed from the container and applied to the axilla. The paper was covered with plastic wrap and tape around the edges with paper tape. The filter paper was left in contact with the axilla for a period of 5 minutes as measured by a stopwatch. The filter paper was then replaced in the sealed container and re-weighed. Rate of sweat production was calculated in milligrams/minute. Assessments conducted at Day 1, Pre-dose time point (average pre-dose measurements for both left and right measurements) were considered as Baseline values. Percent change from Baseline= 100 x ( Day 15 value – Baseline value) / Baseline value. The percentage of participants with cutpoints (-30%, -50, -75%) for percent change from Baseline in sweat production were presented.
Time Frame Baseline (Pre-dose, Day 1) and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vehicle
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 18 5
Measure Type: Number
Unit of Measure: Percentage of participants
<=-30% 59 60
<=-50% 41 40
<=-75% 29 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Umeclidinium, 2 mg/cm^2 of 1.85%, OD, Vehicle
Comments Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vs Vehicle: <=-30%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference in treatment
Estimated Value -1
Confidence Interval (2-Sided) 95%
-42.2 to 39.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Umeclidinium, 2 mg/cm^2 of 1.85%, OD, Vehicle
Comments Umeclidinium, 2 mg/cm^2 of 1.85%, OD vs Vehicle: <=-50%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference in treatment
Estimated Value 1
Confidence Interval (2-Sided) 95%
-39.9 to 42.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Umeclidinium, 2 mg/cm^2 of 1.85%, OD, Vehicle
Comments Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vs Vehicle: <=-70%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference in treatment
Estimated Value 9
Confidence Interval (2-Sided) 95%
-25.2 to 44.0
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change in Hyperhidrosis Disease Severity Scale (HDSS) at Day 15
Hide Description The HDSS is a 4-point scale which used to assess the impact of disease. The scores were define as, 1- My (underarm) sweating is never noticeable and never interferes with my daily Activities; 2- My (underarm) sweating is tolerable but sometimes interferes with my daily activities; 3- My (underarm) sweating is barely tolerable and frequently interferes with my daily activities; 4- My (underarm) sweating is intolerable and always interferes with my daily activities. Average score of both left and right underarms were used for analysis. The possible average score range from 1 (minimum) to 4 (maximum). The reduction in score on the scale presents betterment and increase in the score represents worsening. Assessments conducted at Day 1, pre-dose time point (average pre-dose measurements for both left and right underarm measurements) were considered as Baseline values. Change from baseline was calculated as Day 15 Visit Value minus Baseline values.
Time Frame Baseline (Pre-dose, Day 1) and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vehicle
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 17 5
Mean (Standard Error)
Unit of Measure: Score on Scale
-1.4  (1.00) -0.6  (0.89)
22.Secondary Outcome
Title Percentage of Participants With 2-point Decrease From Baseline to Day 15 in HDSS Score
Hide Description HDSS is a 4-point scale which used to assess the impact of disease. The scores are define as, 1- My (underarm) sweating is never noticeable and never interferes with my daily Activities; 2- My (underarm) sweating is tolerable but sometimes interferes with my daily activities; 3- My (underarm) sweating is barely tolerable and frequently interferes with my daily activities; 4- My (underarm) sweating is intolerable and always interferes with my daily activities. Average score of both left and right underarms were used for analysis. The possible average score range from 1 (minimum) to 4 (maximum). Increase in score on scale represents worsening. Assessments conducted at Day 1, pre-dose time point (average pre-dose measurements for both left and right underarm measurements) were considered as Baseline values. Change from baseline was calculated as Day 15 Visit Value minus Baseline values. Percentage of participants with 2-point decrease from Baseline to Day 15 in HDSS score were reported.
Time Frame Baseline (Pre-dose, Day 1) and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vehicle
Hide Arm/Group Description:
Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
Overall Number of Participants Analyzed 17 5
Measure Type: Number
Unit of Measure: Percentage of participants
47 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Umeclidinium, 2 mg/cm^2 of 1.85%, OD, Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference in treatment
Estimated Value 27
Confidence Interval (2-Sided) 95%
-8.5 to 62.6
Estimation Comments [Not Specified]
Time Frame AEs were collected up to end of the follow-up. The end of the follow-up duration for the study 202093 was Day 28, for the study AC4112008 was Day 50 and for the study LHH117157 Day 18.
Adverse Event Reporting Description Safety population of study number 202093, LHH117157 (Cohort B) and AC4112008 were used to report SAEs and nSAEs.
 
Arm/Group Title 202093:Umeclidinium 202093:Vehicle AC4112008: GSK573719 LHH117157: Cohort B
Hide Arm/Group Description Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days. Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days. Each participants received single dose of treatment in the following order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. The washout was of 5 days between two consecutive periods. A single dose of topically applied [14C] umeclidinium administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% (w/w) solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 (cm^2) surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg).
All-Cause Mortality
202093:Umeclidinium 202093:Vehicle AC4112008: GSK573719 LHH117157: Cohort B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/5 (0.00%)      0/10 (0.00%)      0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
202093:Umeclidinium 202093:Vehicle AC4112008: GSK573719 LHH117157: Cohort B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/5 (0.00%)      0/10 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
202093:Umeclidinium 202093:Vehicle AC4112008: GSK573719 LHH117157: Cohort B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/18 (50.00%)      2/5 (40.00%)      6/10 (60.00%)      2/6 (33.33%)    
Ear and labyrinth disorders         
Ear pain  1  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Eye disorders         
Abnormal sensation in eye  1  0/18 (0.00%)  1/5 (20.00%)  0/10 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders         
Nausea  1  0/18 (0.00%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Flatulence  1  0/18 (0.00%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Gastrointestinal sounds abnormal  1  0/18 (0.00%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
General disorders         
Application site pain  1 [1]  3/18 (16.67%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Application site pruritus  1 [1]  2/18 (11.11%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Application site erythema  1 [1]  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Application site exfoliation  1 [1]  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Application site paraesthesia  1 [1]  0/18 (0.00%)  1/5 (20.00%)  0/10 (0.00%)  0/6 (0.00%) 
Chest pain  1 [1]  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Asthenia  1  0/18 (0.00%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Application site iiritation  1  0/18 (0.00%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Application site dryness  1  0/18 (0.00%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Catheter site inflammation  1  0/18 (0.00%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Infections and infestations         
Bronchitis  1  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Nasopharyngitis  1  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders         
Limb discomfort  1  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Pain in extrmity  1  0/18 (0.00%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Nervous system disorders         
Headache  1  4/18 (22.22%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Dizziness  1  1/18 (5.56%)  0/5 (0.00%)  2/10 (20.00%)  0/6 (0.00%) 
Presyncope  1  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Lethargy  1  0/18 (0.00%)  0 0/5 (0.00%)  2/10 (20.00%)  0/6 (0.00%) 
Sensory disturbance  1  0/18 (0.00%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Psychiatric disorders         
Anxiety  1  0/18 (0.00%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Renal and urinary disorders         
Urinary hesitation  1  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  1/18 (5.56%)  1/5 (20.00%)  0/10 (0.00%)  0/6 (0.00%) 
Epistaxis  1  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Paranasal sinus discomfort  1  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Nasal congestion  1  0/18 (0.00%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Blister  1  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Dermatitis atopic  1  1/18 (5.56%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Rash papular  1  0/18 (0.00%)  1/5 (20.00%)  0/10 (0.00%)  0/6 (0.00%) 
Dermatitis contact  1  0/18 (0.00%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Vascular disorders         
Thrombophlebitis  1  0/18 (0.00%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
1
Term from vocabulary, MedDRA, Version 18.1
Indicates events were collected by systematic assessment
[1]
General disorders and administration site conditions
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02563899     History of Changes
Other Study ID Numbers: 202093
First Submitted: September 28, 2015
First Posted: September 30, 2015
Results First Submitted: March 16, 2017
Results First Posted: November 17, 2017
Last Update Posted: October 11, 2018