Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy

Completed

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk

Key facts

Study ID

NCT04184297

Run by

Boehringer Ingelheim

People needed

27190

Starts

2019-11-01

Expected to finish

2019-11-04

Last updated by the study team

2021-11-15

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• New users of Tio+Olo on the same date or of LABA, LAMA and ICS, either as a fixed-dose combination (LABA/LAMA/ICS) or free combination (LABA/ICS + LAMA, etc), on the same date between January 2013 and March 2019.
• Diagnosis of COPD prior to first maintenance inhaler and age ≥ 40 years at index date

You may not qualify if…

• Less than one year of medical history information prior to the date of combined treatment initiation (index date)
• Lung cancer, interstitial lung disease, or lung transplantation at any time prior to the index date
• Asthma diagnosis within one year prior to the index date

Where it is running

• HealthCore, Inc. — Andover, Massachusetts, United States

Full record on ClinicalTrials.gov

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