Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease

NCT02157935 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2026

Last updated 2017-11-07

Study results available
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Summary

Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD).

Conditions

  • COPD Patients

Interventions

DRUG

Symbicort

Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses

DRUG

Formoterol turbohaler

Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses

OTHER

Placebo for Symbicort pMDI

pMDI, aerosol for oral inhalation, placebo, 120 doses

OTHER

Placebo for Formoterol Turbohaler

PLacebo powder for oral inhalation, 60 doses

Sponsors & Collaborators

Principal Investigators

  • Gary T Ferguson, MD · Pulmonary Research Insititute of Southeast Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-27
Primary Completion
2016-02-08
Completion
2016-02-08

Countries

  • United States
  • Argentina
  • Bulgaria
  • Chile
  • Czechia
  • Germany
  • Mexico
  • Poland
  • Puerto Rico
  • South Africa
  • Spain

Study Locations

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Entities

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 NCT02157935 on ClinicalTrials.gov