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Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

NCT00975195 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2488

Last updated 2015-02-10

Study results available
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Summary

This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

tiotropium inhalation

DRUG

salmeterol xinafoate

DRUG

fluticasone propionate

DRUG

placebo matched for fluticasone propionate

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • China
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • New Zealand
  • Philippines
  • Poland
  • Russia
  • South Africa
  • Spain
  • Taiwan
  • Tunisia
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

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 NCT00975195 on ClinicalTrials.gov