Last reviewed · How we verify

NCT01899638

Pharmacokinetics Of Umeclidinium and Vilanterol in Healthy Chinese, a Randomized, Open Label, 3 Crossover Study.

Completed Phase 1 Last updated 7 June 2017
What this trial tests

Phase 1 trial testing UMEC/VI 125/25 mcg in Pulmonary Disease, Chronic Obstructive in 20 participants. Completed in 25 July 2013.

Timeline
20 May 2013
Primary endpoint
25 July 2013
25 July 2013

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment20
Start date20 May 2013
Primary completion25 July 2013
Estimated completion25 July 2013
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 45, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg and 125µg) and VI (25µg) as monotherapies and combinations in healthy Chinese subjects.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pharmacokinetics and tolerability of inhaled umeclidinium and vilanterol alone and in combination in healthy Chinese subjects: a randomized, open-label, crossover trial.
    Hu C, Jia J, Dong K, Luo L, et al · · 2015 · cited 12× · PMID 25816315 · DOI 10.1371/journal.pone.0121264
  2. Evidence-based review of data on the combination inhaler umeclidinium/vilanterol in patients with COPD.
    Albertson TE, Bowman WS, Harper RW, Godbout RM, et al · · 2019 · cited 3× · PMID 31239659 · DOI 10.2147/copd.s191845

Verify or expand the search:

Other recruiting trials for Pulmonary Disease, Chronic Obstructive

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01899638.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing