NCT02308098

To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product

Study Comparing Bronchodilator Efficacy of Two Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler; a Randomised, Double-blind, Double-dummy, Multicentre, Single Dose, Crossover Study in Asthmatic Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh
DRUG	Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh
DRUG	Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
DRUG	Symbicort Turbuhaler 320/9 ug/inhalation 1inh
DRUG	Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
DRUG	Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh
DRUG	Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh
DRUG	Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-12-04
• Last updated: 2015-06-30

Locations

1 site across 1 country: Bulgaria