COPD

GlaxoSmithKline and Theravance have initiated a global Phase III trial to assess the safety and efficacy of the ‘closed’ triple combination in patients with chronic obstructive pulmonary disease (COPD).

IMPACT is the first Phase III trial in a programme to assess a once-daily closed triple combination treatment of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist in COPD patients.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The triple combination comprises of FF (fluticasone furoate, an ICS), UMEC (umeclidinium, a LAMA) and VI (vilanterol, a LABA).

A total of 10,000 patients across 38 countries will be enrolled in the double-blind, three-arm, parallel group trial, which will evaluate whether the triple combination delivered in GSK‘s Ellipta inhaler can reduce the annual rate of moderate and severe exacerbations.

The trial will compare the triple combination with two approved once-daily COPD treatments; ICS/LABA combination Relvar/Breo Ellipta and Anoro Ellipta , which is a LAMA/LABA combination.

See Also:

GSK head of respiratory therapy area unit, R&D, Dave Allen said: "When developing our respiratory portfolio, we recognised the need to offer a range of molecules that could be co-formulated in different combinations to meet the needs of individual patients.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
"This Phase III programme has the potential to demonstrate the safety and efficacy profile of a new and important therapy."

"We know from the scientific literature and prescribing data that there are already COPD patients who receive three medicines in different inhalers, for whom a once-daily treatment in a single ‘closed’ device could be valuable.

"The IMPACT study will be important in advancing our understanding of how the combination of FF/UMEC/VI could be used in this setting when compared to dual combination therapy options."

Theravance chief executive officer Rick Winningham said: "The start of the IMPACT study marks a significant milestone in our development programme with GSK and we are excited about the potential opportunity for a triple combination treatment approach.

"This Phase III programme has the potential to demonstrate the safety and efficacy profile of a new and important therapy that could deliver additional benefits and convenience to the growing number of adults living with COPD worldwide."

In the trial, eligible patients will be randomly to receive either FF/UMEC/VI 100/62.5/25mcg, FF/VI 100/25mcg or UMEC/VI 62.5/25mcg once-daily for a period of 52 weeks.

Co-primary endpoints of the trial are the annual rate of moderate and severe exacerbations comparing FF/UMEC/VI with FF/VI, and the annual rate of moderate and severe exacerbations comparing FF/UMEC/VI with UMEC/VI.

Image: A chest X-ray demonstrating severe chronic obstructive pulmonary disease (COPD). Photo: courtesy of James Heilman.