A Non-Interventional Study of Tiotropium/Olodaterol versus Any Triple Combination Therapy for Chronic Obstructive Pulmonary Disease: The EVELUT® Study Protocol.

Abstract

Background:

The Global Initiative for Chronic Obstructive Lung Disease 2020 report recommends that patients with chronic obstructive pulmonary disease (COPD) suffering from persistent dyspnea, despite long-acting β2-agonist (LABA)/inhaled corticosteroid (ICS) maintenance therapy, are switched to either a long-acting muscarinic antagonist (LAMA)/LABA combination regimen or LAMA/LABA/ICS triple therapy. However, to date, no studies have investigated the direct switch from LABA/ICS to LAMA/LABA therapy-instead of switching to triple therapy-in a prospective, real-world, non-interventional setting.

Methods:

EVELUT® (NCT03954132) is an ongoing, prospective, open-label, multicenter, non-interventional study comparing the once-daily fixed-dose combination of tiotropium and olodaterol (tio/olo) versus any triple therapy (LAMA/LABA/ICS) in patients with COPD who are symptomatic despite LABA/ICS maintenance therapy. Patients with acute or frequent COPD exacerbations are excluded from the study. Participants will receive LABA/ICS maintenance treatment until Visit 1, followed by switching of treatment to tio/olo or LAMA/LABA/ICS. The primary endpoints are changes in modified Medical Research Council (mMRC) and COPD Assessment Test (CAT®) scores after approximately 12 weeks of treatment. Secondary endpoints are change in the patients' general condition according to the Physician's Global Evaluation score, the proportion of responders with a change in mMRC score of ≥1 and in CAT® score of ≥2, and patient satisfaction with the inhaler and therapy. The study is expected to enroll approximately 900 patients.

Conclusion:

EVELUT results are expected to add to the current real-world evidence informing therapeutic decisions for COPD in everyday clinical practice.

Trial Registration:

The European Union electronic Register of Post-authorisation Studies (EU PAS Register): EUPAS29784; the Federal Institute for Drugs and Medical Devices (BfArM): NIS Study No 7305; Clinicaltrials.gov: NCT03954132.

• Authors: Roland Buhl, Michael Dreher, Stephanie Korn, Christian Taube, Christian Stock, Christoph M Zehendner, Anke Kondla, Claus F Vogelmeier
• Journal: International journal of chronic obstructive pulmonary disease (Int J Chron Obstruct Pulmon Dis) Vol. 15 Pg. 2601-2608 ( 2020) ISSN: 1178-2005 [Electronic] New Zealand
• PMID: 33122898 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: © 2020 Buhl et al.

Chemical References

• Adrenergic beta-2 Receptor Agonists
• Benzoxazines
• Bronchodilator Agents
• Muscarinic Antagonists
• olodaterol
• Tiotropium Bromide

Topics

• Administration, Inhalation
• Adrenergic beta-2 Receptor Agonists (adverse effects)
• Benzoxazines
• Bronchodilator Agents (adverse effects)
• Drug Therapy, Combination
• Humans
• Multicenter Studies as Topic
• Muscarinic Antagonists (adverse effects)
• Prospective Studies
• Pulmonary Disease, Chronic Obstructive (diagnosis, drug therapy)
• Tiotropium Bromide (adverse effects)