Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BDP
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...
Beclomethasone dipropionate breath-actuated inhaler is an investigational inhaled corticosteroid therapy being developed by Teva Pharmaceutical Industries Limited for persistent asthma. It delivers beclomethasone dipropionate through a breath-actuated inhaler device, a small molecule formulation studied in patients aged 12 years and older with persistent asthma.
It is being studied for the treatment of persistent asthma in patients 12 years of age and older. The Phase 3 program evaluated two dose levels, 80 and 160 mcg per day, delivered via the breath-actuated inhaler in a 12-week safety and efficacy study conducted in the United States.
Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA, is the developer of the beclomethasone dipropionate breath-actuated inhaler. The company sponsored the Phase 3 clinical program evaluating the product in persistent asthma.
Beclomethasone dipropionate breath-actuated inhaler is in Phase 3 development. The single Phase 3 trial in the program has been completed, and no trials are currently listed as active. It is an investigational product and has not been approved by the FDA for persistent asthma.
The program includes one completed Phase 3 trial, NCT02040779, titled a 12-week safety and efficacy study of beclomethasone dipropionate at 80 and 160 mcg per day delivered via breath-actuated inhaler in patients 12 years and older with persistent asthma. It enrolled 273 participants in the United States.
NCT02040779 was a randomized, double-blind, placebo-controlled Phase 3 study. It enrolled 273 patients aged 12 years and older with persistent asthma across sites in the United States and ran for 12 weeks, evaluating beclomethasone dipropionate at 80 and 160 mcg per day delivered by breath-actuated inhaler.