Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BDP HFA · 2 trials · 3 indications
Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale: * 0 = absent (no sign/symptom present) * 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) * 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization.
* Area under the plasma concentration time curve until the last measurable value (AUClast) for 17-BMP * Maximum plasma concentration (Cmax) for 17-BMP
| Arm | Type | Description |
|---|---|---|
| BDP HFA 80 mcg/day | EXPERIMENTAL | Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. |
| BDP HFA 160 mcg/day | EXPERIMENTAL | Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. |
| Placebo nasal aerosol once daily | PLACEBO_COMPARATOR | Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days. |
| BDP HFA Nasal Aerosol 80 mcg/d | EXPERIMENTAL | single dose, intranasal aerosol |
| BDP HFA Nasal Aerosol 320 mcg/d | EXPERIMENTAL | single dose, intranasal aerosol |
| BDP HFA Inhalation Aerosol 320 mcg/d | ACTIVE_COMPARATOR | single dose, orally inhaled aerosol |
| Name | Type | Description |
|---|---|---|
| BDP HFA | DRUG | BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm. |
| Placebo nasal aerosol | DRUG | Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period. |
| BDP HFA Nasal Aerosol | DRUG | BDP HFA Nasal 80mcg |
| BDP HFA Inhalation Aerosol (QVAR) | DRUG | BDP HFA Oral 320mcg |
Inclusion Criteria: * Male or female subjects 6 to 11 years of age, as of the Screening Visit (SV) * A documented history of SAR to a relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV). * A demonstrated sensitivity to at le...
BDP HFA is an investigational small molecule nasal aerosol being developed by Teva Pharmaceutical Industries Limited (TEVA) for the treatment of allergic rhinitis, including seasonal allergic rhinitis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BDP HFA is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker symbol TEVA. The drug is an investigational small molecule nasal aerosol intended for respiratory conditions such as allergic rhinitis.
BDP HFA is currently in Phase 1 clinical development. Although a Phase 3 trial has been completed, the drug remains investigational and has not received regulatory approval. Teva is continuing to study its safety and pharmacokinetics in early-stage trials.
BDP HFA has been studied in two clinical trials. NCT01307319 was a Phase 3 study in children aged 6-11 with seasonal allergic rhinitis, enrolling 715 participants. NCT01537692 was a Phase 1 pharmacokinetics and safety study in healthy adults with allergic rhinitis, enrolling 30 participants.
BDP HFA is a nasal aerosol formulation of beclomethasone dipropionate, a corticosteroid commonly used to treat allergic rhinitis. While it shares the active ingredient with some approved products, BDP HFA itself is an investigational formulation that has not been approved for marketing.