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Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01397890 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 793

Last updated 2015-03-27

Study results available
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Summary

This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD).

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Budesonide/formoterol (Symbicort® Turbuhaler®)

Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily

DRUG

Tiotropium (SpirivaTM)

Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily

Sponsors & Collaborators

Principal Investigators

  • Samuel Chen, M.D. · AstraZeneca Pharmaceutical Co., Ltd., Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • China
  • Hong Kong
  • Indonesia
  • South Korea
  • Thailand

Study Locations

More Related Trials

Entities

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 NCT01397890 on ClinicalTrials.gov