Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.)

NCT01555138 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 581

Last updated 2015-04-28

Study results available
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Summary

The purpose of this study is to compare the effectiveness and safety of indacaterol with salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone propionate.

Conditions

Interventions

DRUG

Indacaterol

Indacaterol is delivered via a SDDPI.

DRUG

Salmeterol

Salmeterol/fluticasone is delivered via a MDDPI

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Argentina
  • Colombia
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

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 NCT01555138 on ClinicalTrials.gov