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COMPLETED
NCT02227394
PHASE2

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

Sponsor: Zambon SpA

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2014-08

Completion Date

2014-11

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

DRUG

Z7200

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)

DRUG

Symbicort® Turbohaler®

Total dose budesonide/formoterol is 320 mcg/9 mcg. At visit 2 or 3 (cross-over design)

Locations (1)

Antwerp University Hospital

Edegem, Antwerp, Belgium