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Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01069289 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1293

Last updated 2012-10-25

Study results available
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Summary

The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.

Conditions

Interventions

DRUG

Budesonide/formoterol (Symbicort Turbuhaler)

2x160/4.5 microgram, inhalation, twice daily, 12 weeks

DRUG

Formoterol (Oxis Turbuhaler)

2 X 4.5 microgram, inhalation, twice daily, 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Lars-Göran Carlsson, MD · AstraZeneca R&D, Lund, Sweden

  • Yoshinosuke Fukuchi, M.D., PhD · Department of Respiratory medicine, Juntendo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • India
  • Japan
  • Philippines
  • Poland
  • Russia
  • South Korea
  • Taiwan
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01069289 on ClinicalTrials.gov