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Efficacy and Safety of Two Dry Power Inhalers (DPIs) Used for the Application of Mometasone in the Treatment of Asthma

NCT00975741 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2009-09-11

No results posted yet for this study

Summary

Mometasone furoate (MF) is a new potent synthetic corticosteroid. Internationally, MF is administered by a breath-actuated DPI and supplied in multidose devices. Capsules to be administered through a monodose device that would offer an alternative to MF DPI multidose treatment in terms of cost-effectiveness were developed in Brazil. The aim of the present non-inferiority clinical study was to evaluate both devices in terms of efficacy and safety.

Conditions

Interventions

DEVICE

OXIMAX

DEVICE

ASMANEX TWISTHALER

Sponsors & Collaborators

  • Mantecorp Industria Quimica e Farmaceutica Ltd.

    lead INDUSTRY

Principal Investigators

  • Carlos Alberto C Pereira, MD, PhD · Hospital do Servidor Público Estadual, São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Completion
2003-08-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

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 NCT00975741 on ClinicalTrials.gov