Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Beclomethasone dipropionate breath-actuated inhaler · 1 trial · 1 indication
The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-12wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit (Day 1), each treatment visit (Weeks 2, 4, 8 and 12) and any unscheduled visit (such as the early termination visit). This summary is based on observed values recorded as 'best attempt'. 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 |
|---|---|---|
| BDP 80 mcg BAI | EXPERIMENTAL | 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day. |
| BDP 160 mcg BAI | EXPERIMENTAL | 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day. |
| Placebo BAI | PLACEBO_COMPARATOR | Placebo breath-actuated inhaler (BAI) twice daily. |
| Name | Type | Description |
|---|---|---|
| Beclomethasone dipropionate breath-actuated inhaler | DRUG | Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order. |
| Placebo breath-actuated inhaler | DRUG | Placebo was provided in matching breath-actuated inhaler (BAI) devices. The placebo devices were identical to the devices used to deliver active drug. Placebo was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order. |
| albuterol/salbutamol | DRUG | Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period |
Inclusion Criteria: * Severity of Disease: The patient has persistent asthma, with an forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) reference values at screening visi...