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A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma

NCT00545272 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2013-01-18

Study results available
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Summary

This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

Conditions

Interventions

DRUG

indacaterol

Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

DRUG

formoterol

Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.

DRUG

placebo to indacaterol

Placebo TWISTHALER® device

DRUG

placebo to formoterol

Placebo AEROLIZER® device

DRUG

short acting β2-agonist

100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharma · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Belgium
  • Czechia
  • Germany
  • Hungary
  • Israel
  • Poland
  • Russia
  • South Africa
  • Spain
  • 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 NCT00545272 on ClinicalTrials.gov