At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double Blind, Double Dummy, Randomized, Two Way Cross-over Study to Compare the Effects of Z7200 and Symbicort® Turbohaler on Functional Respiratory Imaging Parameters in Asthmatic Patients.
In Brief
A Phase 2 clinical trial evaluating Z7200 and Symbicort® Turbohaler® for Asthma and 3 related conditions. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Total dose budesonide/formoterol is 160 mcg/4.5 mcg) to be administered only with the inhaler device (RS-01). At visit 2 or 3 (cross-over design)
Total dose budesonide/formoterol is 320 mcg/9 mcg. At visit 2 or 3 (cross-over design)