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Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

NCT01609478 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2015-01-27

Study results available
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Summary

To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.

Conditions

Interventions

DRUG

indacaterol

indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler

DRUG

placebo

placebo delivered via Concept 1 inhaler

DRUG

mometasone furoate

via Twisthaler inhaler

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Bulgaria
  • Canada
  • Germany
  • Japan
  • Netherlands
  • Poland
  • Slovakia
  • South Korea

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 NCT01609478 on ClinicalTrials.gov