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A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan

NCT01070784 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2014-04-29

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.

Conditions

Interventions

DRUG

Symbicort Turbuhaler (Budesonide/formoterol)

2 x 160/4.5 microgram, inhalation, bid, 52 weeks

DRUG

Drug: any available COPD treatment; investigator to decide

According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision

Sponsors & Collaborators

Principal Investigators

  • Tomas Andersson, MD · AstraZeneca, R&D, Lund, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Japan

Study Locations

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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 NCT01070784 on ClinicalTrials.gov