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A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

NCT00615459 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2011-08-17

Study results available
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Summary

The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Indacaterol

Indacaterol 150 μg or 300 μg, delivered via SDDPI

DRUG

Tiotropium

Tiotropium 18 μg once daily delivered via inhalation device

DRUG

Placebo

Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharma · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Australia
  • Germany
  • Netherlands
  • New Zealand
  • Poland
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Drugs
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 NCT00615459 on ClinicalTrials.gov