CompletedPhase 2

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

United States, Canada28 participantsStarted 2015-11-23

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 case…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Plasma Concentration After Repeat Dosing of Umeclidinium

Timeframe: Day 12 to Day 16

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

Timeframe: 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)

Mean Time to Reach Cmax (Tmax) of Umeclidinium After Repeat Dosing

Timeframe: Day 14 to Day 16

Mean Terminal Plasma Elimination Rate Constant (Lambda Z) of Umeclidinium After Repeat Dosing

Timeframe: Day 14 to Day 16

Terminal Phase Half-life (t1/2) of Umeclidinium After Repeat Dosing

Timeframe: Day 14 to Day 16

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

Timeframe: Day 14 to Day 16

Trial details

NCT IDNCT02563899

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-02-25

Results submitted2017-03-16

View on ClinicalTrials.gov More Hyperhidrosis trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean Plasma Concentration After Repeat Dosing of Umeclidinium

Timeframe: Day 12 to Day 16

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

Timeframe: 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)

Mean Time to Reach Cmax (Tmax) of Umeclidinium After Repeat Dosing

Timeframe: Day 14 to Day 16

Mean Terminal Plasma Elimination Rate Constant (Lambda Z) of Umeclidinium After Repeat Dosing

Timeframe: Day 14 to Day 16

Terminal Phase Half-life (t1/2) of Umeclidinium After Repeat Dosing

Timeframe: Day 14 to Day 16