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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01256086 | Relative Potency of Formoterol Novolizer® 12 µg Compared to Formoterol Aerolizer® 12 µg | PHASE2 | COMPLETED | 44 | — | — | Dec 1, 2010 | Jul 1, 2011 | Feb 11, 2022 | 3 | United States |
The primary variable is the methacholine PC20 after inhalation of study medication; the PC20 is the concentration of methacholine that - despite protection by study medication - causes a 20% fall in FEV1 compared to the pre-methacholine (post-saline) level of the given study day.
| Arm | Type | Description |
|---|---|---|
| 24 µg Formoterol Novolizer | EXPERIMENTAL | 12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| 12µg Formoterol Novolizer | EXPERIMENTAL | 12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| 24 µg Formoterol Aerolizer | ACTIVE_COMPARATOR | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2 |
| 12µg Formoterol Aerolizer | ACTIVE_COMPARATOR | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2 |
| Name | Type | Description |
|---|---|---|
| Formatris 24µg | DRUG | 12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| Formatris 12µg | DRUG | 12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| Foradil P 24µg | DRUG | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2 |
| Foradil P 12µg | DRUG | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2 |
Inclusion Criteria: 1. Male or female patients aged from 18 to 60 years (inclusive). 2. Patients with asthma indicated by * history of asthma symptoms and * airway hyperresponsiveness to methacholine with a provocation concentration of methacholine that cause a 20% decrease in FEV1 (PC20) ≤8...