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Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control

NCT00393458 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1732

Last updated 2011-08-18

Study results available
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Summary

This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.

Conditions

Interventions

DRUG

Indacaterol

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

DRUG

Formoterol

Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).

DRUG

Placebo to indacaterol

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

DRUG

Placebo to formoterol

Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).

Sponsors & Collaborators

Principal Investigators

  • Novartis Investigator Site · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Argentina
  • Chile
  • Colombia
  • Czechia
  • Denmark
  • Ecuador
  • Egypt
  • Estonia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Peru
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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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 NCT00393458 on ClinicalTrials.gov