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Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma

NCT00557440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2013-03-21

Study results available
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Summary

This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using fluticasone/salmeterol as an active control.

Conditions

Interventions

DRUG

fluticasone propionate/salmeterol

Fluticasone propionate/salmeterol 250/50 μg twice daily delivered via MDDPI.

DRUG

indacaterol maleate / mometasone furoate

Indacaterol maleate / mometasone furoate 500/400 μg once daily delivered via the TWISTHALER device.

DRUG

placebo to indacaterol/mometasone

Placebo to indacaterol maleate/mometasone furoate delivered via the TWISTHALER device.

DRUG

placebo to fluticasone propionate/salmeterol

Placebo to fluticasone propionate / salmeterol delivered via MDDPI.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharma · Novartis Pharmaceuticals

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
2007-11-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Belgium
  • Germany

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 NCT00557440 on ClinicalTrials.gov