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Also known as BDP, breath-actuated inhaler
Beclomethasone dipropionate BAI · 1 trial · 1 indication
Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. Baseline was defined as baseline trough morning percent predicted FEV1. Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest ('best attempt') FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used.
| Arm | Type | Description |
|---|---|---|
| BDP 80 mcg BAI | EXPERIMENTAL | Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day). Placebo MDI twice daily for blinding. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study. |
| BDP 160 mcg BAI | EXPERIMENTAL | Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day). Placebo MDI twice daily for blinding. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study. |
| BDP 80 mcg MDI | ACTIVE_COMPARATOR | Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day). Placebo BAI twice daily for blinding. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study. |
| BDP 160 mcg MDI | ACTIVE_COMPARATOR | Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day). Placebo BAI twice daily for blinding. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study. |
| Placebo BAI and MDI | PLACEBO_COMPARATOR | Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study. |
| Name | Type | Description |
|---|---|---|
| Beclomethasone dipropionate BAI | DRUG | Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a breath-actuated inhaler (BAI) at levels of 40 mcg or 80 mcg per inhalation, twice each day. |
| Placebo BAI | DRUG | Placebo was delivered by a single inhalation using a breath-actuated inhaler (BAI) twice each day. |
| albuterol/salbutamol 90 mcg | 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. |
| Beclomethasone dipropionate MDI | DRUG | Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a metered-dose inhaler (MDI) at levels of 40 mcg or 80 mcg per inhalation, twice each day. |
| Placebo MDI | DRUG | Placebo was delivered by a single inhalation using a metered-dose inhaler (MDI) twice each day. |
Inclusion Criteria: * Written informed consent * Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National Institute of Health (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 medicatio...
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| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
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| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
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| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
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| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
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Beclomethasone dipropionate BAI is an inhaled asthma treatment being developed for persistent asthma in children ages 4 to 11 years old. It delivers beclomethasone dipropionate through a breath-actuated inhaler, a device that releases the drug when the patient inhales. It is a small molecule therapy in the respiratory area.
Beclomethasone dipropionate BAI is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program evaluating this breath-actuated inhaler formulation of beclomethasone dipropionate for asthma.
Beclomethasone dipropionate BAI is in Phase 3 development. It is an investigational product and has not been approved by the FDA. The Phase 3 trial evaluating it has been completed, and no trials for this asset are currently listed as active.
Beclomethasone dipropionate BAI was studied in one Phase 3 trial, NCT02040766, titled A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma. The trial is completed and enrolled 628 participants.
The Phase 3 trial NCT02040766 was a randomized, double-blind, placebo-controlled study of beclomethasone dipropionate delivered by breath-actuated inhaler or metered-dose inhaler in children ages 4 to 11 with persistent asthma. It enrolled 628 participants across the United States, Croatia, Mexico, Poland, and Ukraine, and is completed.