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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

Brief Summary:

This is a double blind (sponsor unblind), repeat dose, randomized, parallel group, placebo controlled study to assess the pharmacokinetic parameters, safety, tolerability, and clinical effect of topically applied umeclidinium following once daily topical administration to axilla for 14 days in subjects with primary axillary hyperhidrosis. This study will determine whether topically applied umeclidinium can decrease hyperhidrosis without systemic anticholinergic effects (ie. in the range or lower to those obtained after inhaled route) at the highest possible concentration.

Subjects will be dosed by site staff each night immediately before bedtime for 14 days. Subjects will complete gravimetric and Hyperhidrosis Disease Severity Scale (HDSS) measurements, patient reported outcomes (PRO), safety assessments, and/or pharmacokinetic sampling. Follow up visits will occur on days 15, 16, 19, 23 and 28. The total duration of the study will be approximately 6 to 8 weeks. The study is planned to enroll approximately 24 subjects.


Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: Umeclidinium Drug: Vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a Study to Evaluate the Pharmacokinetic, Safety, Tolerability and Clinical Effect of Topically Applied Umeclidinium/GSK573719 in Subjects With Primary Axillary Hyperhidrosis
Actual Study Start Date : November 23, 2015
Actual Primary Completion Date : February 25, 2016
Actual Study Completion Date : February 25, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Umeclidinium
Subjects will receive umeclidinium once daily before bedtime for 14 days.
Drug: Umeclidinium
Umeclidinium (GSK573719) 1.85% will be supplied as a clear, colorless solution, free from visible particulates, for topical application. This formulation will be available at a concentration of 18.5 milligrams (mg) umeclidinium parent per gram. 2 mg of this formulation will be applied per square centimeter of the axilla, once a day at night before going to bed for 14 days. The total amount of formulation applied daily to both axillae is expected to range between approximately 204 and 680 mg. Total daily dosage of the active pharmaceutical ingredient (umeclidinium parent) to both axillae will range between approximately 3.8 and 12.6 mg. If certain pre-specified criteria for safety and tolerability are met, consideration will be given to decreasing the dose by decreasing the concentration of the topical formulation to 1.15% for the remaining subjects. This lower strength formulation will contain 11.5 mg parent per gram.

Placebo Comparator: Vehicle
Subjects will receive vehicle once daily before bedtime for 14 days.
Drug: Vehicle
The vehicle will be supplied as a clear, colorless solution, free from visible particulates, for topical application. This formulation will be similar to the umeclidinium formulation except that it will be devoid of the umeclidinium parent. 2 mg of the vehicle will be applied per square centimeter of the axilla, once a day at night before going to bed for 14 days. The total amount of vehicle applied daily to both axillae is expected to range between approximately 204 and 680 mg.




Primary Outcome Measures :
  1. Mean Plasma Concentration After Repeat Dosing of Umeclidinium [ Time Frame: Day 12 to Day 16 ]
    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).

  2. Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) After Repeat Dosing of Umeclidinium [ 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) ]
    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.

  3. Mean Time to Reach Cmax (Tmax) of Umeclidinium After Repeat Dosing [ Time Frame: Day 14 to Day 16 ]
    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.

  4. Mean Terminal Plasma Elimination Rate Constant (Lambda Z) of Umeclidinium After Repeat Dosing [ Time Frame: Day 14 to Day 16 ]
    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).

  5. Terminal Phase Half-life (t1/2) of Umeclidinium After Repeat Dosing [ Time Frame: Day 14 to Day 16 ]
    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).

  6. 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 [ Time Frame: Day 14 to Day 16 ]
    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.

  7. Composite Population Pharmacokinetics Parameter: Volume of Distribution in Central Compartment (V1) and Volume of Distribution in Peripheral Compartment (V2) [ Time Frame: Day 12 to Day 16 ]
    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.

  8. Composite Population Pharmacokinetics Parameter: Elimination Clearance (CL) and Inter-compartmental Clearance (Q) [ Time Frame: Day 12 to Day 16 ]
    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.

  9. Composite Population Pharmacokinetics Parameter: Absorption Rate Constant (Ka) [ Time Frame: Day 12 to Day 16 ]
    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.

  10. 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]) [ Time Frame: Day 12 to Day 16 ]
    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.

  11. Composite Population Pharmacokinetics Parameter: Duration of the Zero Order Process and Lag Time for the First Order Absorption Process (ALAG1) [ Time Frame: Day 12 to Day 16 ]
    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.

  12. Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE) [ Time Frame: Over a period of 28 days ]
    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.

  13. Number of Participants With Abnormal Values of Potential Clinical for Electrocardiogram (ECG) [ Time Frame: Up to Day 28 ]
    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.

  14. Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance at Any Time on Treatment [ Time Frame: Up to day 28 ]
    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.

  15. Number of Participants With Clinical Hematology Abnormalities of Potential Clinical Importance at Any Time on Treatment. [ Time Frame: Up to Day 28 ]
    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.

  16. Number of Participants With Urinalysis Abnormalities of Potential Clinical Importance at Any Time on Treatment [ Time Frame: Up to Day 28 ]
    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.

  17. Number of Participants With Abnormal Values of Potential Clinical for Vital Signs [ Time Frame: Up to 28 days ]
    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.

  18. Number of Participants With Local Tolerability Assessment Score Over 28 Days [ Time Frame: Days 1, 2, 4, 5, 6, 7, 8, 9, 10, 13, 14, 15, 16, and 23 ]
    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).


Secondary Outcome Measures :
  1. Change From Baseline in Amount of Sweat Produced at Day 15 [ Time Frame: Baseline (Pre-dose, Day 1) and Day 15 ]
    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.

  2. Percentage of Participants With Cut-points for Percent Change From Baseline in Sweat Production at Day 15 [ Time Frame: Baseline (Pre-dose, Day 1) and Day 15 ]
    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.

  3. Change in Hyperhidrosis Disease Severity Scale (HDSS) at Day 15 [ Time Frame: Baseline (Pre-dose, Day 1) and Day 15 ]
    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.

  4. Percentage of Participants With 2-point Decrease From Baseline to Day 15 in HDSS Score [ Time Frame: Baseline (Pre-dose, Day 1) and Day 15 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 18 and 65 years of age inclusive, at the time of signing the informed consent.
  • A Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4.
  • A diagnosis of primary, axillary hyperhidrosis, defined as excessive, bilateral, axillary sweating of at least 6 months duration without apparent cause and with at least 1 of the following characteristics: subject has a positive family history of hyperhidrosis, hyperhidrosis is bilateral and relatively symmetrical, subject experienced first episode of hyperhidrosis before 25 years of age, subject experiences cessation of focal sweating during sleep.
  • A baseline gravimetric assessment of at least 50 milligrams sweat produced at rest by each axilla during a period of 5 minutes (measurements can be repeated up to 2 times on two different days, screening and baseline visits, but subjects need to qualify on at least one occasion).
  • Male.
  • A female is eligible to enter and participate in the study if she is of:

Non-child bearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, > 45 years, in the absence of hormone replacement therapy. In questionable cases for women < 60 years of age, a blood sample with simultaneous follicle stimulating hormone and estradiol falling into the central laboratory's postmenopausal reference range is confirmatory.

OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician) for the duration of the study: abstinence; oral contraceptive, either combined or progestogen alone; injectable progestogen; implants of levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device (IUD) or intrauterine system (IUS) that meets the standard operating procedure effectiveness criteria as stated in the product label; male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject; double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository

  • If subjects have shaved axilla or removed hair by other means within the last 2 weeks, there should be minimal to no irritation.
  • Capable of giving signed informed consent which includes compliance with the pre-specified requirements and restrictions.

Exclusion Criteria:

  • Unstable or life threatening cardiac disease. In the opinion of the investigator, use should only be considered if the benefit is likely to outweigh the risk in conditions such as: myocardial infarction or unstable angina in the last 6 months, unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months, New York Heart Association (NYHA) Class IV heart failure.
  • Diagnosis of narrow-angle glaucoma, urinary retention, prostatic hypertrophy or bladder neck obstruction that in the opinion of the study investigator or GlaxoSmithKline (GSK) Medical Monitor would prevent use of an anticholinergic and therefore study participation.
  • Irritation or active infection of axillary area, including sweat glands.
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones that the investigator deems clinically significant).
  • Alanine aminotransferase (ALT) > 2 x Upper Limit of Normal (ULN) and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) at screening.
  • Corrected QT Interval (QTc) > 450 milliseconds (ms) or QTc > 480 ms in subjects with Bundle Branch Block.

The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read.

The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial.

For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used.

  • Prior surgical procedure for hyperhidrosis.
  • Axillary treatment with radiofrequency and microwave devices.
  • Treatment with axillary iontophoresis within 4 weeks prior to Baseline/Day 1.
  • Menopausal women who have had symptoms of menopause such as sweating or flushing within 3 years of the study.
  • Used any prohibited medication within the indicated washout period.
  • Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, sympathomimetic.
  • Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
  • A positive pre-study drug/alcohol screen at screening.
  • A positive test for Human Immunodeficiency Virus (HIV) antibody at screening.
  • The subject has participated in a clinical trial and has received an investigational product within the following time periods prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day.
  • Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study (e.g., subjects with renal failure).
  • Subjects with clinically significant abnormalities in laboratory values for which, according to the investigator, study participation would put the subject at undue risk.
  • Abnormal findings on screening electrocardiogram (ECG) deemed clinically significant by the Investigator.
  • Women who are pregnant or lactating or are planning on becoming pregnant during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563899


Locations
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United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78759
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02563899     History of Changes
Other Study ID Numbers: 202093
First Posted: September 30, 2015    Key Record Dates
Results First Posted: November 17, 2017
Last Update Posted: October 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com
Keywords provided by GlaxoSmithKline:
Primary Axillary Hyperhidrosis
GSK573719
Hyperhidrosis Disease Severity Scale (HDSS)
Topical
PRO
Hyperhidrosis Symptom Severity Measure (HSSM)
Umeclidinium
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases