A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD
NCT01192191 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 187
Last updated 2017-01-11
Summary
The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD.
Conditions
- Pulmonary Disease, Chronic Obstructive
Interventions
- DRUG
-
Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
- DRUG
-
Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-08-31
- Primary Completion
- 2012-01-31
- Completion
- 2012-01-31
Countries
- Japan
Study Locations
More Related Trials
-
Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01054885 ·Status: COMPLETED ·Phase: PHASE3
-
A 24-week Study of Fluticasone Furoate/Vilanterol Inhalation Powder in Subjects of Asian Ancestry With COPD
NCT01376245 ·Status: COMPLETED ·Phase: PHASE3
-
An Investigation of the Pharmacokinetics of GSK961081 and Fluticasone Propionate in Healthy Volunteers
NCT01449799 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate and Fluticasone Propionate in People With Asthma
NCT01436110 ·Status: COMPLETED ·Phase: PHASE3
-
Long-term Safety Study for GSK573719/GW642444 in Japanese
NCT01376388 ·Status: COMPLETED ·Phase: PHASE3
-
Enhancement of in-Vitro GC Function in Patients With COPD
NCT00241631 ·Status: COMPLETED ·Phase: PHASE2
-
Change in Symptom and Quality of Life in COPD by Budesonide/Glycopyrronium/Formoterol Fumarate Pressurized Metered Dose Inhaler (BGF pMDI)
NCT05219630 ·Status: COMPLETED
-
A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease
NCT00774761 ·Status: COMPLETED ·Phase: PHASE2
-
A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01168310 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma
NCT01573624 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With a Next-Generation Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
NCT05573464 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Show That Flutiform is Well Tolerated and Effective in the Treatment of COPD
NCT01946620 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD
NCT03256552 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
NCT03836677 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT01047553 ·Status: COMPLETED ·Phase: PHASE3
-
Long-term Safety Study for GSK573719 in Japanese
NCT01702363 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))
NCT01342913 ·Status: COMPLETED ·Phase: PHASE3
-
PK of BDP/FF/GB Single-inhaler Triple Therapy in Japanese vs. Caucasians
NCT03859414 ·Status: COMPLETED ·Phase: PHASE1
-
Establish FeNO Cut-off Value for Predicting Budesonide-formoterol Response in Chronic Cough Suggestive of CVA Patients.
NCT06590740 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Japanese Patients With COPD
NCT00824382 ·Status: COMPLETED ·Phase: PHASE2
-
GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
NCT00269087 ·Status: COMPLETED ·Phase: PHASE3
-
A Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Fluticasone Propionate/Salmeterol (FSC) 250/50 Microgram (mcg) Through a Capsule-Based Inhaler and a Multi-Dose Inhaler Administered Twice Daily (BID) in Adults With Chronic Obstructive Pulmonary Disease (COPD)
NCT01978145 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01323621 ·Status: COMPLETED ·Phase: PHASE3
-
A 24-week Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 125/25 mcg and 62.5/25mcg Inhalation Powder Compared With Placebo in Subjects With COPD
NCT01636713 ·Status: COMPLETED ·Phase: PHASE3
-
The Effects of Inhaled Budesonide-formoterol-glycopyrronium in Moderate-to-severe COPD
NCT04675463 ·Status: UNKNOWN ·Phase: NA