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Also known as beclomethasone dipropionate (QVAR), BDP, QNASL(TM), QNASL®, BDP Nasal Aerosol
Beclomethasone dipropionate · 6 trials · 5 indications
Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. The baseline pulmonary function measurement was defined as the measurement obtained at randomization visit (Day 1). 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 FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 5 attempts) was used. Baseline-adjusted FEV1 AUEC(0-12wk) were calculated using the trapezoidal rule. The standardized baseline-adjusted FEV1 AUEC(0-12 wk) accommodates participants who dropped out of the study. Baseline-adjusted FEV1 AUEC(0-t weeks)/t, where t =12 weeks for patients who complete the FEV1 assessment at Week 12. For participants who dropped out early, t \<12 weeks (2, 4, or 8 weeks).
Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an "other pre-specified" outcome.
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping). The rTNSS (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement.
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.
| Arm | Type | Description |
|---|---|---|
| BDP 320 mcg BAI | EXPERIMENTAL | Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily. |
| BDP 640 mcg BAI | EXPERIMENTAL | Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily. |
| BDP 320 mcg MDI | ACTIVE_COMPARATOR | Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. |
| BDP 640 mcg MDI | ACTIVE_COMPARATOR | Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. |
| Placebo BAI and MDI | PLACEBO_COMPARATOR | Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily. |
| Placebo | PLACEBO_COMPARATOR | Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone. |
| BDP HFA 320 µg/day | EXPERIMENTAL | Participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone. |
| Prednisone | ACTIVE_COMPARATOR | Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule. |
| Name | Type | Description |
|---|---|---|
| Beclomethasone dipropionate | DRUG | - |
| Placebo | DRUG | - |
| Albuterol/salbutamol | 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. |
| Placebo Nasal Aerosol | DRUG | Placebo nasal aerosol administered daily for 42 days of treatment |
| Prednisone capsules | DRUG | Prednisone 10 mg capsule taken each day on the last 7 days of treatment |
| Placebo Prednisone Capsules | DRUG | Placebo prednisone capsule taken each day on the last 7 days of treatment |
| beclomethasone dipropionate (QVAR) | DRUG | - |
Inclusion Criteria: * Severity of disease: The patient has persistent asthma, with a forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) (Hankinson et al 1999) reference va...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 27 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | tilrekimig and rHuPH20, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Beclomethasone dipropionate is used to treat asthma, perennial allergic rhinitis, and seasonal allergic rhinitis. It is a small molecule therapy in the respiratory therapeutic area. Clinical development has covered patients aged 12 years and older across these allergic and inflammatory airway conditions.
Beclomethasone dipropionate is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company has sponsored Phase 3 clinical trials of the drug in asthma and allergic rhinitis indications.
Beclomethasone dipropionate is in Phase 3 clinical development. All four listed trials are Phase 3 studies, and all have been completed. The program includes randomized, double-blind, placebo-controlled trials in asthma and allergic rhinitis.
Beclomethasone dipropionate has been studied in completed Phase 3 trials including NCT02031640 in persistent asthma, NCT01133626 in perennial allergic rhinitis, NCT01024608 in seasonal allergic rhinitis, and NCT00988247 in allergic rhinitis. Total enrollment across these studies was 1,968 participants aged 12 years and older.
Yes, beclomethasone dipropionate is also known as beclomethasone dipropionate (QVAR). QVAR is an alternative name used for this Teva Pharmaceutical Industries Limited product, which has been evaluated in Phase 3 trials for asthma and allergic rhinitis.