drugset / Trial / NCT02227394

Study to Compare the Effects of Z7200 And Symbicort® Turbohaler on Respiratory Imaging Parameters in Asthmatic Patients

NCT02227394

Phase 2 Completed 20 enrolled Zambon SpA FLUIDDA nv · collab
RandomizedCrossoverTriple-blindTreatment

Summary

Primary objective: The primary objective of this study is to evaluate the effect of the products under investigation on functional respiratory imaging parameters and evaluate the particle deposition with Computational fluid dynamics (CFD). Secondary Objectives: The secondary objectives of this study were to assess the effect of test product and reference product on: * lung function (spirometry and body plethysmography), * exercise capacity (6-Minute Walking Test \[6MWT\] or equivalent method to measure exercise tolerance), * dyspnea (Borg Category \[C\] Ratio \[R\] 10 \[Borg CR10\] scale and Visual Analogue Scale \[VAS\] dyspnea). Furthermore, the safety of the test product and reference product was evaluated through monitoring of AEs throughout the study.

Timeline

Start
2014-08
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Symbicort Turbohaler Unknown Inhaled
Subject Z7200 Unknown Inhaled

Indications