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A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880) | Clinical Trials | Clareo Health

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A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)

A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Mild Persistent and Moderate Persistent Asthmatic Patients

NCT00442117•Organon and Co

View on ClinicalTrials.gov

Summary

This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated with inhaled corticosteroids (ICS) or without ICS with diagnosed mild persistent or moderate persistent asthma (classified as Global Initiative For Asthma, 2005) in the previous 4 weeks. The primary efficacy endpoint is percent change from baseline in FEV1.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must be 12 years of age or older of either gender, who (and their parent/guardian if the subject is under the age of 20) must demonstrate their willingness to sign and write informed consent.
•Subjects must have had a history of asthma for at least 6 months.
•The subject must be diagnosed mild persistent or moderate persistent asthma and his/her FEV1 must be \>= 60% of predicted normal at both the Screening and Baseline visits, when short-acting inhaled beta agonists have been withheld for at least six hours and long-acting inhaled beta agonists have been withheld for at least 12 hours.
•Subjects must demonstrate an increase in absolute FEV1 of \>= 12%, with an absolute volume increase of at least 200 mL, after reversibility testing at the Screening visit, or historically within the past 12 months; Subjects without documented absolute FEV1 of \>= 12% in reversibility test within the past 12 months need to demonstrate a positive result in Methacholine challenge test.
•If Subjects with ICS treatment have been using ICS on a daily basis for at least 4 weeks prior to Screening. For the two weeks prior to Screening, subjects must have been on a stable regimen of ICS. Each ICS dose is shown in following:
•* Flunisolide between 1000 to 2000 mcg/day
•* Budesonide between 400 to 800 mcg/day
•* Triamcinolone acetonide between 600 to 1600 mcg/day
•* Beclomethasone Dipropionate between 252 to 840 mcg/day
•* Fluticasone propionate between 200 to 500 mcg/day
+3 more criteria

Exclusion Criteria

•Female subjects who are pregnant, breast-feeding, or are pre-menarcheal.
•Subjects who are heavy smokers (more than 10 pack years) or who smoked within previous 6 months.
•Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 14 days during the 3 months immediately prior to the Screening visit, and/or subjects who have required a course of systemic corticosteroids within the previous month.
•Subjects who used Leukotriene modifiers within 2 weeks of screening.
•Subjects who took immunosuppressive agents within the previous 3 months.
•Subjects who use daily nebulized ß2-adrenergic agonists.
•Subjects who have had either an asthma exacerbation or a clinically relevant change in asthma medication within the last 4 weeks.
•Subjects who have been admitted to the hospital for asthma control within the previous 3 months or have needed emergency service for asthma more than once within the previous 6 months.
•Subjects who have required ventilator support for respiratory failure secondary to their asthma within the last 5 years.
•Subjects who have used any investigational drug in the 30 days prior to Baseline, or subjects who have been treated with any investigational antibody for asthma in the 90 days prior to Baseline.
+3 more criteria

Key Dates

Start Date

June 1, 2007

Primary Completion Date

July 1, 2009

Completion Date

July 1, 2009

Last Updated

May 20, 2024

Enrollment

180

ACTUAL participants

Conditions

Asthma

Interventions

mometasone furoate dry powder inhaler

DRUG

Budesonide DPI

DRUG

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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