Exacerbation Study

NCT00845728 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3439

Last updated 2013-11-19

Study results available
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Summary

This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks

Conditions

Interventions

DRUG

Indacaterol 150 µg

Indacaterol 150 µg o.d. delivered via SDDPI

DRUG

Tiotropium

Tiotropium 18 µg o.d. delivered via handihaler®

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
2009-03-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Colombia
  • Costa Rica
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Iceland
  • India
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom
  • Venezuela

Study Locations

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Entities

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 NCT00845728 on ClinicalTrials.gov