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

NCT02308098 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2015-06-30

No results posted yet for this study

Summary

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

Conditions

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 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

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Hristo Metev, MD · Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Bulgaria

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 NCT02308098 on ClinicalTrials.gov