The Role of Inhaler Device in the Treatment Persistence with Dual Bronchodilators in Patients with COPD

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30839
• EU PAS number:
  EUPAS30838
• Study ID:
  30839
• Official title and acronym:
  The Role of Inhaler Device in the Treatment Persistence with Dual Bronchodilators in Patients with COPD
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Stiolto® Respimat®, a combination of Olodaterol and Tiotropium Bromide delivered via soft mist inhaler (SMI), was approved in May 2015 in the US and July 2015 in the EU (marketed as Spiolto in the EU). Anoro® Ellipta®, a combination of Umeclidinium and Vilanterol delivered via dry powder inhaler (DPI), was approved in December 2013 in the US and in February 2014 in the EU. Both products are maintenance therapies consisting of a combination of long-acting muscarinic antagonists (LAMA) and long-acting beta agonists (LABA). However, the question of whether different devices (DPI and SMI) play a role in treatment persistence remains to be answered. This study seeks to compare the treatment persistence of two drugs in same drug class (LAMA/LABA as a fixed dose combination FDC) delivered through different devices (a DPI and a SMI) within an administrative claims database in the US.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Aetion

Spain

Study timelines

Date when funding contract was signed

Planned: 26/02/2019

Actual: 26/02/2019

Study start date

Planned: 10/06/2019

Actual: 10/06/2019

Data analysis start date

Planned: 11/06/2019

Actual: 11/06/2019

Date of final study report

Planned: 30/03/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable