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Clinical Trials/NCT00206154
NCT00206154CompletedPhase 3

A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients

AstraZeneca210 sites in 2 countries1,500 target enrollmentStarted: April 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
1,500
Locations
210
Primary Endpoint
Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •A clinical diagnosis of COPD with symptoms for more than 2 years
  • •Smoking history of 10 or more pack years
  • •A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.

Exclusion Criteria

  • •A history of asthma
  • •Patients taking oral steroids.
  • •Any significant disease or disorder that may jeopardize the safety of the patient

Outcomes

Primary Outcomes

Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period

Secondary Outcomes

  • Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
  • Health care utilization
  • Pharmacokinetics (subgroup)
  • Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
  • - all variables assessed over the 6 months treatment period

Investigators

Sponsor Class
Industry

Study Sites (210)

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