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Dose Ranging Study for Indacaterol in Japanese Asthma Patients

NCT00403754 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2011-08-17

Study results available
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Summary

This study was designed to provide data about the safety and efficacy of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or doses, could be chosen for testing in later studies.

Conditions

Interventions

DRUG

Indacaterol

In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).

DRUG

Placebo

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

DRUG

Salmeterol

Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals Japan · Novartis Pharmaceuticals Japan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
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 NCT00403754 on ClinicalTrials.gov