drugset / Trial / NCT04078126

Study Comparing Dual Combination of Product (Budesonide and Formoterol) Given Via Two Different Inhalers. To See Which One Results in the Best Effect on Breathing.

NCT04078126 ↗

Phase 3 Completed 35 enrolled AstraZeneca
RandomizedCrossoverOpen-labelTreatment

Summary

Study comparing the same drugs as a dual combination product (budesonide and formoterol) given via two different inhalers. To see which one results in the best effect on breathing.

Timeline

Start
2019-09-10
Primary completion
2020-12-30
Completion
2020-12-30

Outcome

Missed primary endpoint

registry analysis (other test); BFF MDI vs Symbicort Turbuhaler; p = 0.3450; Mean Difference (Final Values) -0.017 (95% CI -0.054 to 0.020); ANCOVA NCT04078126 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 320 ug Inhaled
Subject Formoterol Other / unclassified 9 ug Inhaled
Subject Formoterol Other / unclassified 10 ug Inhaled