Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07525375 | 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 | PHASE2 | RECRUITING | 69 | — | — | Apr 14, 2026 | May 23, 2029 | Apr 22, 2026 | 39 | United States, Argentina +5 |
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.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence ABC | EXPERIMENTAL | Participants will receive three treatments in sequence: Treatment A, Treatment B followed by Treatment C for 3 weeks each. |
| Treatment Sequence BCA | EXPERIMENTAL | Participants will receive three treatments in sequence: Treatment B, Treatment C followed by Treatment A for 3 weeks each. |
| Treatment Sequence CAB | EXPERIMENTAL | Participants will receive three treatments in sequence: Treatment C, Treatment A followed by Treatment B for 3 weeks each. |
| Treatment Sequence ACB | EXPERIMENTAL | Participants will receive three treatments in sequence: Treatment A, Treatment C followed by Treatment B for 3 weeks each. |
| Treatment Sequence BAC | EXPERIMENTAL | Participants will receive three treatments in sequence: Treatment B, Treatment A followed by Treatment C for 3 weeks each. |
| Treatment Sequence CBA | EXPERIMENTAL | Participants will receive three treatments in sequence: Treatment C, Treatment B followed by Treatment A for 3 weeks each. |
| Name | Type | Description |
|---|---|---|
| GP MDI | COMBINATION_PRODUCT | GP MDI will be administered via oral inhalation twice daily (BID). |
| BFF MDI | COMBINATION_PRODUCT | BFF MDI will be administered via oral inhalation BID. |
| Placebo MDI | COMBINATION_PRODUCT | Placebo MDI will be adminsitered via oral inhalation BID. |
Main Inclusion Criteria: * Participants who have a documented history of physician-diagnosed asthma * Participants who have been using a stable and regular inhaled corticosteroid plus one additional asthma controller medication. * Participants must have a Childhood Asthma Control Test score ≥ 19. *...