A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Stu… (NCT00442117) | Clinical Trial Compass
CompletedPhase 3
A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)
180 participantsStarted 2007-06
Plain-language 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.
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 5…
What they're measuring
1
Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.