drugset / Trial / NCT03055988

Cardiovascular Function in COPD Patients

NCT03055988 ↗

Phase 4 Completed 76 enrolled Boehringer Ingelheim
RandomizedCrossoverDouble-blindTreatment

Summary

The objectives of the study are to explore the effect of treatment with tiotropium + olodaterol fixed dose combination (FDC) compared to fluticasone propionate + salmeterol FDC on: * reversal of left ventricular diastolic dysfunction assessed with cardiac magnetic resonance (CMR) imaging, * measures of arterial stiffness assessed by CMR and pulse wave analysis (PWA), * reduction of hyperinflation assessed with body plethysmography and * post dose spirometry.

Timeline

Start
2017-03-29
Primary completion
2018-03-05
Completion
2018-03-26

Outcome

Missed primary endpoint

registry analysis (superiority test); Fluticasone Propionate + Salmeterol FDC (F+S 1000/100) vs Tiotropium + Olodaterol FDC (T+O 5/5); p = 0.6331 NCT03055988 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone propionate Other / unclassified — Inhaled
Subject Olodaterol Small molecule — Inhaled
Comparator Salmeterol Other / unclassified — Inhaled
Subject Tiotropium Other / unclassified — Inhaled