Study to Compare the Effects of Z7200 And Symbicort® Turbohaler on Respiratory Imaging Parameters in Asthmatic Patients
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
Summary
This study will be conducted as a randomized, double blind, double dummy two-period crossover
study in stable asthma patients treated in accordance with the Global Initiative for Asthma
(GINA) guidelines, will be included.
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).The secondary objectives of this study are
to assess the effect of Z7200 and Symbicort® on lung function (spirometry and body
plethysmography), on exercise capacity (6MWT)and on dyspnea (Borg CR10 Scale and VAS
dyspnea). Furthermore the safety of the 2 products under investigation will be evaluated
through monitoring of adverse events throughout the study.
Phase:
Phase 2
Details
Lead Sponsor:
Zambon SpA
Collaborator:
FLUIDDA nv
Treatments:
Budesonide Budesonide, Formoterol Fumarate Drug Combination Formoterol Fumarate