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

NCT02227394 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-01-27

Study results available
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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.

Conditions

  • Asthma
  • Asthma Chronic
  • Asthma Bronchial
  • Asthmatic

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)

Sponsors & Collaborators

  • FLUIDDA nv

    collaborator INDUSTRY

  • Zambon SpA

    lead INDUSTRY

Principal Investigators

  • Wilfried De Backer, MD, PhD · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02227394 on ClinicalTrials.gov