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Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)

NCT00424008 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 722

Last updated 2024-05-20

Study results available
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Summary

This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.

Conditions

Interventions

DRUG

Mometasone furoate/formoterol (MF/F) MDI

MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks.

DRUG

Fluticasone propionate/salmeterol (F/SC) DPI

Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

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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 NCT00424008 on ClinicalTrials.gov