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26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00463567 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 2059

Last updated 2011-08-18

Study results available
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Summary

Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD

Conditions

  • Pulmonary Disease, Chronic Obstructive
  • COPD
  • Lung Diseases, Obstructive

Interventions

DRUG

Indacaterol

In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).

DRUG

Formoterol (12 µg b.i.d.)

Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.

DRUG

Tiotropium (18 µg o.d.)

Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.

DRUG

Placebo to Indacaterol

In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).

DRUG

Placebo to Formoterol

In the morning and in the evening, placebo to formoterol delivered via Aerolizer.

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
2007-04-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States
  • Argentina
  • Canada
  • Germany
  • India
  • Italy
  • Puerto Rico
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

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 NCT00463567 on ClinicalTrials.gov