Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Budesonide HFA · 1 trial · 1 indication
Provocative concentration of methacholine is that causing a 20% fall in FEV1. The methacholine challenge test entailed the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 had been reduced by 20%. The ratio of Methacholine concentration measured at 2 weeks to that at Baseline.
| Arm | Type | Description |
|---|---|---|
| Budesonide Hydrofluoroalkane (HFA) 100 | ACTIVE_COMPARATOR | Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks |
| Budesonide HFA 400 | ACTIVE_COMPARATOR | Budesonide HFA 400 mcg twice daily for 2 weeks |
| Budesonide Chlorofluorocarbon (CFC) 100 | ACTIVE_COMPARATOR | Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks |
| Budesonide CFC 400 | ACTIVE_COMPARATOR | Budesonide CFC 400 mcg twice daily for 2 weeks |
| Name | Type | Description |
|---|---|---|
| Budesonide HFA | DRUG | standard daily inhaled dose |
| Budesonide CFC | DRUG | standard daily inhaled dose |
Inclusion Criteria: * Patients suffering from stable, persistent, mild to moderate asthma as defined by Global Initiative for Asthma (GINA) Guidelines and for whom FEV1 \> 60 % * ICS taking ≤ 1000 μg BDP per day, or equivalent * Methacholine PC20 \< 4 mg/mL Exclusion Criteria: * Known or suspecte...