MedTrace Logo

Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00794157 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2011-08-17

Study results available
· View outcomes & findings →

Summary

This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \[od\]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Indacaterol 150 μg capsules

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

DRUG

Indacaterol 300 μg capsules

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

DRUG

Placebo capsules

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

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
2008-11-30
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • Hong Kong
  • India
  • Japan
  • Singapore
  • South Korea
  • 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 NCT00794157 on ClinicalTrials.gov