Characteristics and Treatment Patterns of Patients with Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance Therapies in the US and the UK: A Retrospective Claims Database Study.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31941
• EU PAS number:
  EUPAS31940
• Study ID:
  31941
• Official title and acronym:
  Characteristics and Treatment Patterns of Patients with Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance Therapies in the US and the UK: A Retrospective Claims Database Study.
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom

  United States
• Study description:
  Chronic obstructive pulmonary disease (COPD) is a common disease characterized by airway obstruction confirmed by spirometry, often including small airway obstruction and emphysema.For patients who are diagnosed with COPD, maintenance treatments often include bronchodilators, primarily long-acting muscarinic antagonists (LAMA), long-acting beta agonists (LABA), and inhaled corticosteroids (ICS) alone or in combination with each other and corticosteroids. Sp(t)iolto® Respimat®, a LAMA+LABA combination, was approved in May 21, 2015 in the US and July 1, 2015 in the EU (marketed as Stiolto in the US and Spiolto in the EU, referred to here as Tio+Olo). Selective prescribing according to patient characteristics, known as channeling, can lead to bias in comparative studies where drugs with similar therapeutic indications are prescribed to groups of patients with prognostic differences. Claimed advantages of a new drug may be distorted if they are channeled to patients with special pre-existing morbidity, with the consequence that disease states can be incorrectly attributed to use of the drug. Therefore, it is important to identify clinical and socio-demographic characteristics of patients who initiate each treatment as opposed to other available maintenance treatments in COPD patients.
• Study status:
  Planned

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: 15/11/2019

Date of final study report

Planned: 30/04/2020

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