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 range
12 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.