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Label indication 1. INDICATIONS AND USAGE QNASL Nasal Aerosol is a corticosteroid indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 4 years of age and older. ( 1.1 ) 1.1 Treatment of Nasal Symptoms of Allergic Rhinitis QNASL ® Nasal Aerosol is indicated for the treatment of the nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 4 years… FDA label
Also known as BDP HFA Nasal Aerosol, QNASL®
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 developed by Teva Pharmaceutical Industries Limited for allergic rhinitis and seasonal allergic rhinitis. It is delivered intranasally and is being studied in both adult and pediatric populations. BDP HFA is also known as BDP HFA Nasal Aerosol.
BDP HFA is being developed for the treatment of allergic rhinitis and seasonal allergic rhinitis. Clinical study NCT01307319 evaluated the nasal aerosol in children ages 6 to 11 with seasonal allergies, and NCT01537692 evaluated pharmacokinetics and safety in adults with allergic rhinitis.
BDP HFA is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program evaluating the nasal aerosol in allergic rhinitis and seasonal allergic rhinitis.
BDP HFA is in clinical development. A Phase 1 pharmacokinetics and safety study, NCT01537692, has been completed, and a Phase 3 study, NCT01307319, in children with seasonal allergic rhinitis has also been completed. The program remains investigational.
BDP HFA has been studied in two completed trials. NCT01537692 was a Phase 1 pharmacokinetics and safety study in 30 healthy adult volunteers with allergic rhinitis. NCT01307319 was a Phase 3 study of 715 children ages 6 to 11 with seasonal allergic rhinitis in the United States.
Yes. BDP HFA and BDP HFA Nasal Aerosol refer to the same investigational product from Teva Pharmaceutical Industries Limited. The nasal aerosol formulation is being studied for allergic rhinitis and seasonal allergic rhinitis.