Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BD MDI 320 µg · 1 trial · 1 indication
Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.
| Arm | Type | Description |
|---|---|---|
| BD MDI 320 µg | EXPERIMENTAL | Budesonide metered dose inhaler (BD MDI) 320 µg (PT008) administered as 2 inhalations BID |
| BD MDI 160 µg | EXPERIMENTAL | BD MDI 160 µg (PT008) administered as 2 inhalations BID |
| BD MDI 80 µg | EXPERIMENTAL | BD MDI 80 µg (PT008) administered as 2 inhalations BID |
| BD MDI 40 µg | EXPERIMENTAL | BD MDI 40 µg (PT008) administered as 2 inhalations BID |
| Placebo MDI | PLACEBO_COMPARATOR | Placebo MDI administered as 2 inhalations BID |
| Name | Type | Description |
|---|---|---|
| BD MDI 320 µg | DRUG | Budesonide Inhalation Aerosol administered as 2 inhalations BID |
| BD MDI 160 µg | DRUG | Budesonide Inhalation Aerosol administered as 2 inhalations BID |
| BD MDI 80 µg | DRUG | Budesonide Inhalation Aerosol administered as 2 inhalations BID |
| BD MDI 40 µg | DRUG | Budesonide Inhalation Aerosol administered as 2 inhalations BID |
| Placebo MDI | DRUG | Placebo MDI administered as 2 inhalations BID |
Inclusion Criteria: * ≥ 18 - 65 years of age * Diagnosis of mild to moderate persistent asthma, diagnosed at least 6 months prior to screening * Currently receiving treatment with a low to medium dose of an inhaled corticosteroid (ICS) OR a combination of controller medications for at least 4 weeks...
BD MDI 320 µg is an investigational small molecule being developed for the treatment of asthma. It is a metered-dose inhaler formulation of budesonide, a corticosteroid, intended for use in adult patients with mild to moderate persistent asthma. The drug is currently in clinical development and has not been approved by regulatory authorities.
BD MDI 320 µg is being developed by cbdMD, Inc., a company publicly traded under the ticker symbol YCBD on the stock market. The company is conducting clinical research to evaluate the safety and efficacy of this investigational asthma treatment.
BD MDI 320 µg is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug remains investigational and has not received FDA approval for any use.
BD MDI 320 µg has been studied in one completed Phase 2 clinical trial with the identifier NCT02105012. This trial, titled 'Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma,' enrolled 147 participants in the United States.
BD MDI 320 µg is a formulation of budesonide, a corticosteroid medication. The clinical trial for BD MDI 320 µg was conducted under the name PT008, which is another designation for the same investigational drug. It is delivered via a metered-dose inhaler for the treatment of asthma.