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Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

NCT00567996 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1002

Last updated 2011-08-18

Study results available
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Summary

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Indacaterol 150 μg

Indacaterol 150 μg once daily (o.d) inhaled

DRUG

Salmeterol 50 μg

Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler

DRUG

Placebo to Indacaterol

Placebo to Indacaterol inhaled via SDDPI.

DRUG

Placebo to Salmeterol

Placebo to salmeterol delivered via a proprietary dry powder inhaler

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharma AG · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-01-31

Countries

  • Canada
  • Colombia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Iceland
  • India
  • Italy
  • Peru
  • Russia
  • Slovakia
  • Taiwan

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 NCT00567996 on ClinicalTrials.gov