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Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00403845 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-08-17

Study results available
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Summary

The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD) so that optimal dose(s) could be chosen for testing in later studies.

Conditions

Interventions

DRUG

Indacaterol 150 μg

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

DRUG

Indacaterol 300 μg

Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals Japan · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
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 NCT00403845 on ClinicalTrials.gov