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Generated: June 22, 2018

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CLINICAL TRIALS PROFILE FOR ANORO ELLIPTA

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Clinical Trials for ANORO ELLIPTA

Trial ID Title Status Sponsor Phase Summary
NCT01899742 The Purpose of the This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotropium 18mcg Once Daily Over a a 12-week Treatment Period in Subjects With COPD Who Continue to Have Completed GlaxoSmithKline Phase 3 The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects with COPD who have received tiotropium and continue to have symptoms while on tiotropium.
NCT02105974 Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Completed GlaxoSmithKline Phase 3 This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on lung function (as measured by trough forced expiratory volume in one second [FEV1]) of FF 100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD. ELLIPTA™ is a registered trademark of GlaxoSmithKline.
NCT02218723 Pharmacokinetic Profile of Four Formulations of Fluticasone Furoate (FF) Using Unit Dose Dry Powder Inhaler (UD-DPI) Compared With FF ELLIPTA® Presentation Completed GlaxoSmithKline Phase 1 This is an open-label, five- period, cross-over, randomized, single dose, single centre study in healthy subjects. This is the second clinical study for the UD-DPI. This study will ascertain whether the Pharmacokinetics (PK) systemic exposure [in terms of area under the plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax)] of FF delivered via the UD-DPI is comparable to the systemic exposure of FF delivered via the ELLIPTA Dry Powder Inhaler (DPI). For this reason four treatment doses consisting of three dose strengths and 2 percentage blends will be assessed when delivered via the UD-DPI. This study is designed to compare the pharmacokinetic profile of various doses and blends of FF administered via UD-DPI and relative to FF administered via ELLIPTA DPI. Subjects will be screened 28 days prior to study initiation. During each treatment period, subjects will be at study site from evening prior to dosing until completion of the 48 hour post-dose PK sample collection on Day 3. Minimum 7 days washout will be between treatments after completion of all five treatments and the follow-up visit will be conducted 7-14 days post last dose. Duration of study is 13 weeks. ELLIPTA is a registered trademark of the GSK group of companies.
NCT02257372 A Study to Evaluate the Effect of Umeclidinium (UMEC) as Combination Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Completed GlaxoSmithKline Phase 4 This is a multicenter, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of the addition of UMEC (62.5 microgram[mcg]) when administered once-daily via dry powder inhaler (DPI) to Inhaled corticosteroid/ Long-acting beta2-agonist (ICS/LABA) twice-daily compared with placebo via DPI added to the ICS/LABA therapy over a treatment period of 12 weeks in subjects with COPD. This study is designed to investigate the addition of UMEC to ICS/LABA combinations at approved doses and frequencies for the treatment of COPD including SERETIDE™ 500/50 mcg twice daily, Fluticasone Propionate/Salmeterol Combination (FSC) 500/50 twice daily generic products such as AIRFLUSAL FORSPIRO inhaler 500/50 mcg twice daily or ROLENIUM ELPENHALER inhaler 500/50 mcg twice daily and SYMBICORT TURBUHALER inhaler at doses of 200/6 mcg twice daily and 400/12 mcg twice daily, over 12 weeks in subjects with COPD. Albuterol/salbutamol metered-dose-inhaler (MDI) or nebules will be issued throughout the study for use as-needed (prn). Subjects who meet the eligibility criteria will be randomly assigned to one of the following blinded study treatment regimens in equal proportion (1:1): UMEC 62.5 mcg once-daily and Placebo once-daily. Approximately 230 subjects (115 subjects per treatment) will be randomized in order to complete at least 206 evaluable subjects. The total duration of the study will be approximately 14 weeks for each subject. UMEC is a Long-acting Muscarinic Antagonist (LAMA) currently under development as a monotherapy, as a combination product with a LABA, vilanterol (VI), for the treatment of COPD, and as a combination product with an ICS, fluticasone furoate (FF), for the treatment of asthma. The UMEC/VI combination 62.5/25 .mcg once-daily has been approved in the United States (U.S.) and Canada for COPD under the trade name ANORO™ ELLIPTA™ and is under regulatory review in other countries. SERETIDE, ANORO, and ELLIPTA are trade marks of the GlaxoSmithKline Group of Companies. Other company or product names mentioned herein may be the property of their respective owners.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for ANORO ELLIPTA

Condition Name

Condition Name for ANORO ELLIPTA
Intervention Trials
Pulmonary Disease, Chronic Obstructive 15
Asthma 11
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Condition MeSH

Condition MeSH for ANORO ELLIPTA
Intervention Trials
Chronic Disease 15
Pulmonary Disease, Chronic Obstructive 15
Lung Diseases 15
Asthma 9
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Clinical Trial Locations for ANORO ELLIPTA

Trials by Country

Trials by Country for ANORO ELLIPTA
Location Trials
United States 91
Germany 66
United Kingdom 10
Mexico 10
Canada 9
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Trials by US State

Trials by US State for ANORO ELLIPTA
Location Trials
South Carolina 10
Florida 8
Oregon 7
Maryland 6
North Carolina 6
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Clinical Trial Progress for ANORO ELLIPTA

Clinical Trial Phase

Clinical Trial Phase for ANORO ELLIPTA
Clinical Trial Phase Trials
Phase 4 8
Phase 3 12
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for ANORO ELLIPTA
Clinical Trial Phase Trials
Completed 14
Recruiting 5
Not yet recruiting 4
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Clinical Trial Sponsors for ANORO ELLIPTA

Sponsor Name

Sponsor Name for ANORO ELLIPTA
Sponsor Trials
GlaxoSmithKline 24
University of Saskatchewan 1
Mundipharma Research Limited 1
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Sponsor Type

Sponsor Type for ANORO ELLIPTA
Sponsor Trials
Industry 25
Other 2
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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Colorcon
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Medtronic
McKesson
Deloitte
Fuji
Express Scripts
Queensland Health

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