Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Beclomethasone Dipropionate 640 · 1 trial · 1 indication
The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-6wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit, each treatment visit (Weeks 2, 4 and 6) and any unscheduled visit (such as the early termination visit). The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used. The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment.
| Arm | Type | Description |
|---|---|---|
| Beclomethasone dipropionate BAI 320 | EXPERIMENTAL | Beclomethasone Dipropionate Delivered via Breath-Actuated Inhaler (BAI) at 320 mcg/day (40 mcg/inhalation, 4 inhalations twice daily) Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods. |
| Beclomethasone dipropionate BAI 640 | EXPERIMENTAL | Beclomethasone Dipropionate Delivered via Breath-Actuated Inhaler (BAI) at 640 mcg/day (80 mcg/inhalation, 4 inhalations twice daily) Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods. |
| Beclomethasone dipropionate MDI 320 | ACTIVE_COMPARATOR | Beclomethasone dipropionate Metered Dose Inhaler (MDI) 320 mcg/day (40 mcg/inhalation, 4 inhalations twice daily) Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods. |
| Placebo | PLACEBO_COMPARATOR | Pooled breath-actuated inhaler (BAI) or metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods. |
| Name | Type | Description |
|---|---|---|
| Beclomethasone Dipropionate 640 | DRUG | Beclomethasone Dipropionate 640 mcg BAI |
| Placebo | DRUG | Placebo, taken in the morning and evening each day, was provided in matching BAI and MDI devices. The placebo devices were identical to the devices used to deliver active drug. |
| Beclomethasone dipropionate via 320 mcg BAI | DRUG | Beclomethasone dipropionate treatment administered via breath-actuated inhaler (BAI) (320 mcg/day). |
| albuterol/salbutamol | DRUG | Each patient's current rescue medication was replaced with study-supplied albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent during the run-in and double-blind study periods. |
| Beclomethasone dipropionate via 320 mcg MDI | DRUG | Beclomethasone dipropionate treatment administered via metered-dose inhaler (MDI) (320 mcg/day). |
Inclusion Criteria: * The patient has a diagnosis of asthma as defined by the NIH. The asthma diagnosis * has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in medication) for at least 30 days. * The patient has been maintained on stable doses...