A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared to BFF in Participants of 4 to Less Than 12 Years of Age With Asthma
Condition(s) studied
Investigational drug(s) / intervention(s)
GP MDI: GP MDI will be administered via oral inhalation twice daily (BID).
BFF MDI: BFF MDI will be administered via oral inhalation BID.
Placebo MDI: Placebo MDI will be adminsitered via oral inhalation BID.
Study summary
The purpose of this study is to evaluate the effect of 2 different GP metered dose inhaler (MDI) doses relative to placebo MDI as add-on treatment to BFF MDI on lung function in participants 4 to less than 12 years of age with asthma.
Eligibility
Primary outcome measure(s)
- Change from baseline in Forced Expiratory volume in one second (FEV1) at 1-hour post-dose measured at End of treatment (EoT) — at 3 weeks
Evaluate the effect of 2 different GP MDI doses relative to placebo MDI as an add-on treatment to BFF MDI on lung function in 4 to less than 12 years old participants with asthma.
Trial sites (44)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Bakersfield | California | Recruiting |
| Research Site | Lancaster | California | Recruiting |
| Research Site | Long Beach | California | Recruiting |
| Research Site | San Diego | California | Not Yet Recruiting |
| Research Site | Miami | Florida | Recruiting |
| Research Site | Pembroke Pines | Florida | Recruiting |
| Research Site | Saint Cloud | Florida | Recruiting |
| Research Site | Owensboro | Kentucky | Recruiting |
| Research Site | Lafayette | Louisiana | Recruiting |
| Research Site | Boston | Massachusetts | Not Yet Recruiting |
| Research Site | Columbia | Missouri | Recruiting |
| Research Site | Cincinnati | Ohio | Not Yet Recruiting |
| Research Site | Oklahoma City | Oklahoma | Recruiting |
| Research Site | Lewisville | Texas | Recruiting |
| Research Site | San Antonio | Texas | Recruiting |
| Research Site | Buenos Aires | Argentina | Recruiting |
| Research Site | CABA | Argentina | Recruiting |
| Research Site | La Plata | Argentina | Not Yet Recruiting |
| Research Site | Lanús Este | Argentina | Not Yet Recruiting |
| Research Site | Lobos | Argentina | Not Yet Recruiting |
| Research Site | Mar del Plata | Argentina | Not Yet Recruiting |
| Research Site | Mendoza | Argentina | Not Yet Recruiting |
| Research Site | Mendoza | Argentina | Recruiting |
| Research Site | Rosario | Argentina | Not Yet Recruiting |
| Research Site | Rosario | Argentina | Recruiting |
| Research Site | San Juan Bautista | Argentina | Not Yet Recruiting |
| Research Site | Santa Fe | Argentina | Not Yet Recruiting |
| Research Site | Brno | Czechia | Not Yet Recruiting |
| Research Site | Prague | Czechia | Not Yet Recruiting |
| Research Site | Budapest | Hungary | Not Yet Recruiting |
| Research Site | Debrecen | Hungary | Recruiting |
| Research Site | Orosháza | Hungary | Not Yet Recruiting |
| Research Site | Szeged | Hungary | Recruiting |
| Research Site | Székesfehérvár | Hungary | Not Yet Recruiting |
| Research Site | Szigetvár | Hungary | Recruiting |
| Research Site | Apodaca | Mexico | Not Yet Recruiting |
| Research Site | Guadalajara | Mexico | Not Yet Recruiting |
| Research Site | San Juan | Mexico | Not Yet Recruiting |
| Research Site | Lodz | Poland | Recruiting |
| Research Site | Tarnów | Poland | Not Yet Recruiting |
+ 4 more sites — see the full list on the official registry below.
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07525375 on ClinicalTrials.gov ↗ ← All trials in Poland