Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02837380

A Phase I Pharmacokinetic Study of Fluticasone Furoate /Umeclidinium Bromide/Vilanterol (100/62.5/25 Microgram [mcg]) After Single and Repeat Dose Administration From a Dry Powder Inhaler in Healthy Chinese Subjects

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:
An Open Label Study to Evaluate the Pharmacokinetics of Fluticasone Furoate /Umeclidinium Bromide/Vilanterol (100/62.5/25 mcg) After Single and Repeat Dose Administration From a Dry Powder Inhaler in Healthy Chinese Subjects

Clinical Trial Summary

This is an open-label study to evaluate the PK of FF/UMEC/VI in dose combinations of 100/62.5/25 mcg after single and repeat dose administration from a DPI in healthy Chinese subjects. This study will evaluate the systemic pharmacokinetics (PK), of FF/UMEC/VI in Chinese healthy population when administered using dry powder inhaler (DPI)as a blended combination of UMEC/VI in one strip and FF in the second strip in dose combinations of 100/62.5/25 mcg. The triple, fixed dose combination product Fluticasone furoate(FF)/ Vilanterol (VI) /Umeclidinium bromide (UMEC) with new configuration enables the delivery of inhaled long-acting muscarinic antagonist (LAMA), Long-acting beta2 agonist (LABA) and inhaled corticosteroid (ICS) from a single device. Approximately 16 subjects will be enrolled in the study. After taking into account the allowable time windows for screening, treatment and follow-up, a subject will be in the study for a maximum duration of 6-7 weeks.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02837380
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date September 2016
Completion date November 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT05043428 - The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD N/A
Completed NCT00528996 - An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler. Phase 2
Completed NCT03740373 - A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate Phase 1
Completed NCT05393245 - Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
Completed NCT05402020 - Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
Completed NCT04011735 - Re-usable Respimat® Soft MistTM Inhaler Study
Enrolling by invitation NCT03075709 - The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
Completed NCT03764163 - Image and Model Based Analysis of Lung Disease Early Phase 1
Completed NCT00515268 - Endotoxin Challenge Study For Healthy Men and Women Phase 1
Completed NCT04085302 - TARA Working Prototype Engagement Evaluation: Feasibility Study N/A
Completed NCT03691324 - Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study N/A
Completed NCT02236611 - A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT00153075 - Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT01017952 - A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT01009463 - A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT04882124 - Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD Phase 2
Completed NCT02853123 - Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients Phase 4
Completed NCT02619357 - Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma Phase 1
Recruiting NCT05858463 - High Intensity Interval Training and Muscle Adaptations During PR N/A
Not yet recruiting NCT05032898 - Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II