Status:

COMPLETED

A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium

Lead Sponsor:

AstraZeneca

Conditions:

Chronic Obstructive Pulmonary Disease

Eligibility:

All Genders

40-80 years

Phase:

PHASE2

Brief Summary

The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function an...

Eligibility Criteria

Inclusion

  • Diagnosis of COPD with symptoms over 1 year
  • Smokers or ex-smokers
  • Males or post-menopausal females between 40 and 80 years old
  • Able to use electronic devices

Exclusion

  • Past history or current evidence of clinically significant heart disease
  • Current diagnosis of asthma
  • Patients who require long term oxygen therapy
  • Treatment with antibiotics within 4 weeks of study visit 1b

Key Trial Info

Start Date :

July 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2010

Estimated Enrollment :

838 Patients enrolled

Trial Details

Trial ID

NCT00949975

Start Date

July 1 2009

End Date

August 1 2010

Last Update

August 3 2012

Active Locations (105)

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Page 1 of 27 (105 locations)

1

Research Site

Fullerton, California, United States

2

Research Site

Valparaiso, Indiana, United States

3

Research Site

Council Bluffs, Iowa, United States

4

Research Site

Hickory, North Carolina, United States