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Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD

NCT02055352 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2017-04-18

Study results available
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Summary

To demonstrate the free combination of budesonide and indacaterol is as efficacious as fluticasone and salmeterol in patients with COPD

Conditions

Interventions

DRUG

Budesonide

Budesonide 400 mcg twice a day via Breezhaler® device

DRUG

Fluticasone

Fluticasone 250 mcg twice daily via Accuhaler® device

DRUG

Indacaterol

Indacaterol 150 mcg once daily via Breezhaler® device

DRUG

Salmeterol

Salmeterol 50 mcg twice daily via Diskus® device

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-30
Primary Completion
2016-01-26
Completion
2016-01-26

Countries

  • Argentina
  • Brazil
  • Chile
  • Dominican Republic
  • Ecuador
  • Honduras
  • Mexico
  • Panama

Study Locations

More Related Trials

Entities

Diseases
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 NCT02055352 on ClinicalTrials.gov