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Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU

NCT00628862 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 613

Last updated 2012-10-25

Study results available
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Summary

The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.

Conditions

Interventions

DRUG

Formoterol Turbuhaler® 4.5mg

4.5 mg inhaled twice daily

DRUG

Formoterol Turbuhaler® 9 mg

9 mg inhaled twice daily

DRUG

Turbuhaler® placebo

placebo inhaled twice daily

Sponsors & Collaborators

Principal Investigators

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

  • Miron A Bogdan, MD · Clinica Medic Or, Calea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Bulgaria
  • Japan
  • Romania
  • Russia
  • Ukraine

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 NCT00628862 on ClinicalTrials.gov