Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomised, Double-blind, Double-dummy, Single Dose, Four Way Cross-over Study to Compare the Pharmacokinetics and Pharmacodynamics of GSK961081 and Fluticasone Propionate When Administered Alone, Concurrently and as a Combination Blend in Healthy Subjects
In the current study GSK961081 and fluticasone propionate will be administered in a blended formulation from a single device and compared with GSK961081 and fluticasone propionate administered alone and concurrently. This is a single centre, randomized, double-blind, double dummy, single dose, four way cross-over study investigating the pharmacokinetics and pharmacodynamics of GSK961081 and fluticasone propionate when administered alone, concurrently and as a combination blend in healthy subjects.
This will be the first time that GSK961081 and fluticasone propionate will be administered as
a blend in humans. In previous clinical studies conducted in Chronic Obstructive Pulmonary
Disease (COPD) patients, GSK961081 has been administered on a background of fluticasone
propionate without any observed systemic pharmacodynamic interaction. In this study GSK961081
and fluticasone propionate will be administered in a blended formulation from a single device
and compared with GSK961081 and fluticasone propionate administered alone and concurrently.
The aim of the study will be to investigate any differences in pharmacodynamics and/or
pharmacokinetics for GSK961081 and fluticasone propionate when administered as the blend,
concurrently or alone.
Pharmacokinetic, pharmacodynamic and safety information will be gathered to assess the
suitability of the GSK9610981/fluticasone propionate blend for further development.Each
subject will receive four treatments (GSK961081 alone, fluticasone propionate alone,
GSK961081 and fluticasone propionate concurrently, and GSK961081/fluticasone propionate
blend) in randomized order, in four treatment periods, each separated by a washout period of
at least a week. All treatments will be administered via a DISKUS inhaler.
Pharmacokinetics, pharmacodynamics and safety will be assessed by measurement of plasma
GSK961081, plasma fluticasone propionate, serum cortisol, urine cortisol, blood glucose,
serum potassium, Forced Expiratory Volume in one second (FEV1), heart rate, 12-lead
Electrocardiograms (ECGs), clinical laboratory tests and collection of adverse events (AEs).
;
| 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
|