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

Phase 3

Completed

• Conditions: Asthma
• Interventions: 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 Symbicort Turbuhaler 320/9 ug/inhalation 1 inh; Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh; Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh

• Registration Number: NCT02308098
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-04
• Status Verified: 2015-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh	Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh	Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh	Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh	Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh	Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh	Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh
Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh	Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh	Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh
Symbicort Turbuhaler 320/9 ug/inhalation 4 inh	Symbicort Turbuhaler 320/9 ug/inhalation 4 inh	Symbicort Turbuhaler 320/9 ug/inhalation 4 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh
Symbicort Turbuhaler 320/9 ug/inhalation 4 inh	Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh	Symbicort Turbuhaler 320/9 ug/inhalation 4 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh
Symbicort Turbuhaler 320/9 ug/inhalation 1 inh	Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh	Symbicort Turbuhaler 320/9 ug/inhalation 1 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh
Symbicort Turbuhaler 320/9 ug/inhalation 1 inh	Symbicort Turbuhaler 320/9 ug/inhalation 1inh	Symbicort Turbuhaler 320/9 ug/inhalation 1 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh

Primary Outcome Measures

Name	Time	Method
Average FEV1	12 h	FEV1 determined from serial spirometry and calculated on the basis of area under the curve

Secondary Outcome Measures

Name	Time	Method
Maximum FEV1	12 h	Maximum FEV1 over the 12-hour serial assessments
FEV1 at 12 h	12 h	FEV1 at 12 hours post-dose

Trial Locations

Locations (1)

Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD; 🇧🇬 Ruse, Bulgaria