CLINICAL TRIALS PROFILE FOR ANORO ELLIPTA

505(b)(2) Clinical Trials for Anoro Ellipta

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02691325 ↗	Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA Dry Powder Inhaler to Healthy Subjects	Completed	GlaxoSmithKline	Phase 1	2016-03-14	GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase delta inhibitor being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airway diseases. The study will be conducted at a single centre and in 3 Parts. The aim of Part A and B of the study are to assess the safety, tolerability and pharmacokinetics (PK) single and repeat doses of a new formulation of GSK2269557 administered via the ELLIPTA dry powder inhaler (DPI) to healthy subjects. This is the first study in which GSK2269557 will be administered via the ELLIPTA DPI. Part C of the study will investigate the proportion of the systemic exposure that post inhalation is due to the swallowed fraction of the inhaled dose. Part C will also be conducted using the ELLIPTA device and magnesium stearate formulation. Part A will be conducted first. Part B and Part C may be run sequentially or in parallel. Part A is a randomized, double blind, placebo controlled, single dose, dose escalating incomplete block 2-period crossover study in healthy subjects. Subjects will be randomized to receive either one dose strength of GSK2269557 and placebo utilizing placebo replacement, or will receive both active dose strengths. Part B is a randomized, double blind, placebo controlled, repeat dose study in healthy Subjects. Subjects will be randomized to receive either repeat doses of GSK2269557 or placebo for 10 days. Part C is a, randomized, open-label, crossover design to assess the systemic exposure of single doses of GSK2269557 administered via the ELLIPTA DPI to healthy subjects, with and without ingestion of activated charcoal. ELLIPTA is the registered trademark of GlaxoSmithKline groups of companies.
New Formulation	NCT03189589 ↗	Safety, Tolerability and Pharmacokinetics (PK) Study of GSK2269557 in Healthy Subjects	Completed	GlaxoSmithKline	Phase 1	2017-06-15	GSK2269557 is being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airways diseases. This is the first study using a new formulation of GSK2269557 in healthy subjects and will evaluate the safety, tolerability and PK of a single dose of GSK2269557. Data derived from this study will inform on the PK profile and systemic exposure expected during Phase 2b. Approximately twelve healthy subjects will be randomized to receive a single dose of GSK2269557 750 micrograms (µg) or a single dose of GSK2269557 500 µg via the ELLIPTA® dry powder inhaler (DPI) formulated in a blend containing 0.4 percent magnesium stearate (MgSt) in 1:1 ratio. This randomized, parallel group study will be carried out in 3 phases, including screening phase, treatment phase and follow-up phase. The total study duration for each subject will be up to 6 weeks. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.

All Clinical Trials for Anoro Ellipta

Trial ID	Title	Status	Sponsor	Phase	Start Date	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 Hav	Completed	GlaxoSmithKline	Phase 3	2014-09-15	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	2014-04-07	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	2014-10-28	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.

Clinical Trial Conditions for Anoro Ellipta

Condition Name

Condition Name for Anoro Ellipta
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	23
Asthma	18
COPD	4

Condition MeSH

Condition MeSH for Anoro Ellipta
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	25
Lung Diseases	25
Chronic Disease	21

Clinical Trial Locations for Anoro Ellipta

Trials by Country

Trials by Country for Anoro Ellipta
Location	Trials
United States	233
Germany	121
Italy	42
United Kingdom	41
Canada	31

Trials by US State

Trials by US State for Anoro Ellipta
Location	Trials
South Carolina	17
Florida	16
North Carolina	15
Texas	14
Ohio	12

Clinical Trial Progress for Anoro Ellipta

Clinical Trial Phase

Clinical Trial Phase for Anoro Ellipta
Clinical Trial Phase	Trials
Phase 4	22
Phase 3	16
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Anoro Ellipta
Clinical Trial Phase	Trials
Completed	31
Not yet recruiting	6
Withdrawn	5

Clinical Trial Sponsors for Anoro Ellipta

Sponsor Name

Sponsor Name for Anoro Ellipta
Sponsor	Trials
GlaxoSmithKline	40
Parexel	5
Swansea University	1

Sponsor Type

Sponsor Type for Anoro Ellipta
Sponsor	Trials
Industry	48
Other	8

Anoro Ellipta: Clinical Trials, Market Analysis, and Projections

Introduction

Anoro Ellipta, a combination bronchodilator treatment developed by GlaxoSmithKline (GSK) and Theravance, has been a significant player in the management of chronic obstructive pulmonary disease (COPD). This article delves into the clinical trials, market analysis, and future projections for Anoro Ellipta.

Clinical Trials and Efficacy

Approval and Indications

Anoro Ellipta was approved for the long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including those with chronic bronchitis and emphysema. It is not indicated for the relief of acute deterioration of COPD or for the treatment of asthma, and it is not recommended for use in children under 18 years of age[1].

Pivotal Studies

The efficacy of Anoro Ellipta was evaluated in three 24-week clinical Phase III studies. These included one randomized, double-blind, parallel-group, placebo-controlled study and two active comparator-controlled studies. The primary efficacy endpoint was the change from baseline in trough forced expiratory volume in 1 second (FEV1) at Day 169. The results supported the efficacy of Anoro Ellipta as a bronchodilator, showing significant improvements in lung function compared to placebo and active comparators[1].

Post-Hoc Analysis

A post-hoc analysis of Phase III data presented at the European Respiratory Society (ERS) International Congress showed that patients with moderate-to-severe COPD who received Anoro Ellipta had a reduced risk of experiencing clinically important deterioration compared to tiotropium or placebo over a 12-week treatment period[3].

Symptomatic Patients on Tiotropium

Data presented at the American Thoracic Society (ATS) 2016 International Conference demonstrated that patients with moderate COPD who remained symptomatic on tiotropium monotherapy showed improved lung function when switched to Anoro Ellipta. This dual bronchodilation approach was highlighted as beneficial for optimizing lung function in symptomatic patients[4].

Safety Profile

Clinical and Non-Clinical Data

Anoro Ellipta has an acceptable safety profile based on both non-clinical data and clinical studies. The identified safety issues are managed through appropriate warnings and precautions in the product monograph. However, it is important to note that, like other LABA-containing products, there is a risk associated with increased asthma-related deaths, as observed in a placebo-controlled trial with another LABA, salmeterol[1][3].

Market Analysis

Market Position and Competition

Anoro Ellipta competes directly with other major COPD treatments, such as Boehringer Ingelheim/Pfizer’s Spiriva. Despite Spiriva’s significant market presence, Anoro Ellipta is expected to be a blockbuster product, especially as Spiriva loses patent protection. The COPD market is anticipated to grow to nearly $16 billion by 2020, with new combination inhalers from Novartis, AstraZeneca, and Forest/Almirall also entering the market[2].

GSK’s Respiratory Franchise

GSK’s strategic shift from a volume-based to a value-based approach is crucial for the success of Anoro Ellipta. The company aims to align closely with customers, particularly primary care physicians and pulmonologists, to drive the adoption of its new respiratory products. GSK’s extensive unbranded direct-to-consumer (DTC) efforts in the asthma space also support the broader respiratory franchise, including Anoro Ellipta[2].

Market Projections

Global COPD Therapeutics Market

The global market for COPD therapeutics is expected to reach $44.1 billion by 2031, growing at a CAGR of 7.3%. New products, including GSK’s Incruse Ellipta and Boehringer’s Stiolto Respimat, are anticipated to gain market share during the forecast period. Anoro Ellipta, with its dual bronchodilation mechanism, is well-positioned to capture a significant share of this growing market[5].

Competitive Landscape

The introduction of new market entrants and the patent expiry of existing products will heighten competition in the COPD therapeutics market. However, Anoro Ellipta’s efficacy and safety profile, combined with GSK’s robust commercial strategy, are expected to help it maintain a strong market position. Other products like AstraZeneca’s Brimica Genuair and Novartis’s Utibron Neohaler will also contribute to the competitive landscape[5].

Key Takeaways

• Clinical Efficacy: Anoro Ellipta has demonstrated significant improvements in lung function in patients with COPD through multiple clinical trials.
• Safety Profile: The drug has an acceptable safety profile, with managed risks through appropriate labeling.
• Market Position: Anoro Ellipta is a key player in the COPD market, competing with established products like Spiriva.
• Market Growth: The global COPD therapeutics market is projected to grow significantly, with Anoro Ellipta poised to capture a substantial share.
• Competitive Landscape: The market will see increased competition from new entrants, but Anoro Ellipta’s dual bronchodilation mechanism and GSK’s commercial strategy position it for continued success.

FAQs

What are the active ingredients in Anoro Ellipta?

Anoro Ellipta contains umeclidinium (a long-acting muscarinic antagonist, LAMA) and vilanterol (a long-acting beta2-adrenergic agonist, LABA)[1].

What is the primary indication for Anoro Ellipta?

Anoro Ellipta is indicated for the long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema[1].

What were the key findings from the pivotal studies of Anoro Ellipta?

The pivotal studies showed significant improvements in trough FEV1 at Day 169, supporting the efficacy of Anoro Ellipta as a bronchodilator[1].

How does Anoro Ellipta compare to other COPD treatments like Spiriva?

Anoro Ellipta competes directly with Spiriva but offers a dual bronchodilation mechanism, which can provide additional benefits for symptomatic patients[2][4].

What is the projected market growth for COPD therapeutics, and how will Anoro Ellipta fit into this market?

The global COPD therapeutics market is expected to reach $44.1 billion by 2031, with Anoro Ellipta poised to capture a significant share due to its efficacy and GSK’s commercial strategy[5].

Sources

1. Health Canada: Summary Basis of Decision for Anoro Ellipta.
2. Pharmaceutical Executive: Deep Breadth: GSK Doubles Down on COPD and Asthma.
3. GSK: GSK presents post-hoc analysis of Anoro® Ellipta® data assessing markers of COPD deterioration compared to tiotropium or placebo using a novel composite endpoint.
4. GSK: GSK presents efficacy data for Anoro® Ellipta® in COPD patients who remained symptomatic on tiotropium.
5. iHealthcareAnalyst: Global Asthma and COPD Therapeutics Market $44.1 Billion by 2031.