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Beclomethasone dipropionate hydrofluoroalkane HFA · 1 trial · 1 indication
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \& PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
| Arm | Type | Description |
|---|---|---|
| BDP HFA 320 µg/day | EXPERIMENTAL | During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. |
| Placebo | PLACEBO_COMPARATOR | During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily. |
| Name | Type | Description |
|---|---|---|
| Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol | DRUG | Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol |
| Placebo Nasal Aerosol | DRUG | HFA Vehicle Aerosol |
Inclusion Criteria: * Informed Consent * Documented history of perennial allergic rhinitis * A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test. * Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a po...
Beclomethasone dipropionate hydrofluoroalkane HFA is being developed for perennial allergic rhinitis, a year-round allergic nasal condition. It is formulated as a nasal aerosol. The program is in Phase 3 development, and the single completed trial enrolled adults and adolescents 12 years of age and older with perennial allergic rhinitis.
Beclomethasone dipropionate hydrofluoroalkane HFA is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva sponsored the Phase 3 study of the nasal aerosol in perennial allergic rhinitis.
Beclomethasone dipropionate hydrofluoroalkane HFA is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The drug is investigational and is not approved for perennial allergic rhinitis.
Beclomethasone dipropionate hydrofluoroalkane HFA has been studied in one Phase 3 trial, NCT01134705, titled Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis). The trial was completed, enrolled 474 participants, was randomized, double blind, and placebo controlled, and was conducted in the United States.
The Phase 3 trial NCT01134705 evaluated beclomethasone dipropionate hydrofluoroalkane HFA in adults and adolescents with perennial allergic rhinitis. It was randomized, double blind, and placebo controlled, enrolled 474 participants, included both sexes, and required a minimum age of 12 years. It did not enroll healthy volunteers.