MedTrace Logo

Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma

NCT00529529 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 805

Last updated 2011-08-29

Study results available
· View outcomes & findings →

Summary

This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily \[od\]), compared with salmeterol (50 μg twice a day \[b.i.d.\]), over 26 weeks, in patients with moderate to severe persistent asthma.

Conditions

Interventions

DRUG

Indacaterol 300 μg

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

DRUG

Salmeterol 50 μg

Salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.

DRUG

Placebo to indacaterol

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

DRUG

Placebo to salmeterol

Placebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States
  • Argentina
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Peru
  • Slovakia
  • Spain
  • 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 NCT00529529 on ClinicalTrials.gov