A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)

NCT00900731 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1598

Last updated 2011-08-19

Study results available
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Summary

This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.

Conditions

Interventions

DRUG

Indacaterol 150 μg

Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

DRUG

Tiotropium 18 μg

Tiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).

DRUG

Placebo to indacaterol

Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

DRUG

Placebo to tiotropium

Placebo to tiotropium was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Colombia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Norway
  • Poland
  • Russia
  • Slovakia
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • 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 NCT00900731 on ClinicalTrials.gov