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...
Beclomethasone Dipropionate 640 is being developed for the treatment of persistent asthma in adolescent and adult patients 12 years of age and older. It is a small molecule therapy in the respiratory therapeutic area. The clinical program studied its use in patients with persistent asthma in the United States.
Beclomethasone Dipropionate 640 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical development program for this asthma therapy.
Beclomethasone Dipropionate 640 is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 3 trial evaluating it in persistent asthma has been completed.
Beclomethasone Dipropionate 640 has been studied in one Phase 3 clinical trial, NCT02513160, titled a study to assess the efficacy and safety of beclomethasone dipropionate in adolescent and adult patients 12 years of age and older with persistent asthma. The trial enrolled 713 patients and has been completed.
The Phase 3 trial NCT02513160 was a randomized, double-blind, placebo-controlled study. It enrolled 713 patients aged 12 years and older with persistent asthma in the United States. The trial has been completed, and it did not select patients based on a biomarker.