Drugs / Beclomethasone
Beclomethasone
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed seasonal allergic rhinitis 2 milestones | |||||
| Filed | US (FDA) | QNASL | seasonal allergic rhinitis | 2014-05-13 | “FDA has accepted for review the company’s supplemental new drug application (sNDA) for a lower dose QNASL®” tevapharm.com ↗ |
| Filed | US (FDA) | QNASL | seasonal allergic rhinitis | 2011-05-24 | “FDA has accepted for filing Teva’s New Drug Application (NDA) for beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA)” tevapharm.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Trimbow | — | 2017-07-17 | europa.eu ↗ |
Trials 37
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05748977 | Feb 2023 → Feb 2024 | chronic obstructive pulmonary disease | Assiut University | Unknown | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT02119234 | Mar 2014 → Feb 2015 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02351180 | Feb 2017 → Jan 2021 | disease related to solid organ transplantation | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1/2 | NCT01176747 | Aug → Sep 2010 | asthma, chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT06482294 | Jun 2024 → May 2025 | asthma | Università degli Studi di Ferrara | Unknown | No outcome recorded |
| Phase 2 | NCT04179461 | Mar 2018 → Oct 2019 | childhood onset asthma | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT02063139 | Feb → Jun 2014 | asthma | Mundipharma Research Limited | Completed | No outcome recorded |
| Phase 2 | NCT01373008 | Jun 2011 → Jun 2016 | bronchopulmonary dysplasia | Bnai Zion Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT00788463 | Nov 2006 → Mar 2009 | nasal cavity polyp | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01244256 | Apr → Aug 2007 | folliculitis | Azidus Brasil | Suspended | No outcome recorded |
| Phase 312 trials · 5 met primary | ||||||
| Phase 3 | NCT03835871 | Feb → Dec 2019 | asthma | Adamis Pharmaceuticals Corporation | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03834012 | Feb → Nov 2019 | asthma | Adamis Pharmaceuticals Corporation | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT01570478 | Jul 2012 → Feb 2014 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT01245569 | Apr 2011 → Mar 2012 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT00861926 | Mar 2009 → Dec 2010 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT00497237 | Apr 2007 → Mar 2010 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT00476099 | Dec 2006 → Aug 2008 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | Mixed |
| Phase 3 | NCT00476268 | Feb 2004 → Jan 2005 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT00382889 | Aug 2002 → Sep 2004 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT00911547 | Mar 1995 → Apr 1996 | asthma | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00000578 | Apr 1994 → Oct 2000 | asthma, lung disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00000576 | Jun 1993 → Apr 1999 | bronchopulmonary dysplasia, respiratory distress syndrome in premature infants | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 414 trials · 1 missed | ||||||
| Phase 4 | NCT06571942 | Nov 2023 → Jan 2025 overdue | chronic obstructive pulmonary disease | National Institute of Respiratory Diseases, Mexico | Recruiting | No outcome recorded |
| Phase 4 | NCT04671355 | Oct → Dec 2021 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Withdrawn | No outcome recorded |
| Phase 4 | NCT03369847 | Sep 2017 → May 2019 | asthma, childhood acute lymphoblastic leukemia | New York City Health and Hospitals Corporation | Completed | No outcome recorded |
| Phase 4 | NCT02687100 | Oct 2016 → Aug 2017 | — | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Withdrawn | No outcome recorded |
| Phase 4 | NCT02577497 | Jun 2016 → Jul 2018 | asthma | University of Virginia | Completed | No outcome recorded |
| Phase 4 | NCT02526758 | Apr 2015 → May 2016 | chronic obstructive pulmonary disease | Zhujiang Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01656005 | Aug 2012 → Jul 2016 | chronic obstructive pulmonary disease | University of Dundee | Completed | No outcome recorded |
| Phase 4 | NCT01550471 | Mar 2012 → Aug 2015 | allergic rhinitis, asthma | West Penn Allegheny Health System | Completed | No outcome recorded |
| Phase 4 | NCT01520688 | Feb 2012 → Feb 2016 | asthma | West Penn Allegheny Health System | Completed | No outcome recorded |
| Phase 4 | NCT01466712 | Nov 2011 → Dec 2014 | pulmonary emphysema | KU Leuven | Unknown | No outcome recorded |
| Phase 4 | NCT00532584 | Feb → Aug 2011 | chronic obstructive pulmonary disease | Weill Medical College of Cornell University | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT00826748 | Nov 2010 → Dec 2014 | chronic obstructive pulmonary disease | Weill Medical College of Cornell University | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT01265342 | Oct 2010 → Mar 2012 | bronchial disorder, respiratory tract infectious disorder | Mario Negri Institute for Pharmacological Research | Completed | Missed primary |
| Phase 4 | NCT00395408 | Jun 2000 → Dec 2003 | asthma | Organon and Co | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00402207 | Aug 2005 → Oct 2006 | asthma | Maastricht University Medical Center | Completed | No outcome recorded |
| Comparator or background therapy27 trials | ||||||
| Phase 1/2 | NCT06871904 Background | Apr → Dec 2025 | oral submucous fibrosis | Ziauddin University | Completed | No outcome recorded |
| Phase 2 | NCT05970731 Comparator | Sep 2023 → Oct 2024 | long COVID-19 | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT04937543 Comparator | Jun → Oct 2021 | COVID-19 | UPECLIN HC FM Botucatu Unesp | Completed | No outcome recorded |
| Phase 2 | NCT04294641 Background | May 2021 → Jun 2024 | chronic graft versus host disease | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT02517099 Comparator | Jun 2015 → Aug 2018 | asthma | Imperial College London | Completed | No outcome recorded |
| Phase 2/3 | NCT06657066 Background | Dec 2021 → Apr 2022 | asthma | King Edward Medical University | Completed | No outcome recorded |
| Phase 2/3 | NCT00119496 Comparator | Jul 2005 → Jun 2007 | asthma | University of Glasgow | Completed | No outcome recorded |
| Phase 3 | NCT06234345 Comparator | Jan 2027 → Aug 2028 expected | chronic obstructive pulmonary disease | Eurofarma Laboratorios S.A. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06429475 Comparator | Jun 2024 → Dec 2028 expected | asthma | University of KwaZulu | Recruiting | No outcome recorded |
| Phase 3 | NCT03846570 Comparator | Jan 2019 → Jul 2022 | bronchiectasis | Erasmus Medical Center | Terminated | No outcome recorded |
| Phase 3 | NCT02113072 Background | Apr → Aug 2014 | asthma | Federal University of Pernambuco | Completed | No outcome recorded |
| Phase 3 | NCT01917331 Background | Mar 2014 → Jan 2016 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | Mixed |
| Phase 4 | NCT07052942 Comparator | Aug 2025 → Nov 2029 expected | acute asthma | DARTNet Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT06272370 Comparator | Feb → Sep 2024 | asthma, hypersensitivity reaction disease, obstructive lung disease, respiratory tract infectious disorder | DARTNet Institute | Completed | No outcome recorded |
| Phase 4 | NCT05352191 Comparator | Sep 2022 → Jan 2023 | — | Western Norway University of Applied Sciences | Unknown | No outcome recorded |
| Phase 4 | NCT02319564 Comparator | Apr → Oct 2016 | — | University of Calgary | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02345993 Comparator | Jan → May 2015 | acute asthma | National Institute of Respiratory Diseases, Mexico | Unknown | No outcome recorded |
| Phase 4 | NCT01741285 Comparator | Apr 2013 → Jul 2015 | asthma | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 4 | NCT01333800 Comparator | Jul → Dec 2010 | asthma | Grünenthal Colombiana S.A. | Completed | No outcome recorded |
| Phase 4 | NCT00962299 Comparator | May 2010 → Jan 2012 | asthma | Princess Amalia Children's Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01255579 Comparator | Jul 2007 → Dec 2008 | asthma | University of Brescia | Completed | No outcome recorded |
| — | NCT07329946 Background | Sep 2026 → Feb 2027 expected | chronic obstructive pulmonary disease | Pierachille Santus, MD, PhD | Not yet recruiting | No outcome recorded |
| — | NCT07267273 Comparator | Nov 2025 → Feb 2026 overdue | vitiligo | Cairo University | Recruiting | No outcome recorded |
| — | NCT07058259 Background | Nov 2024 → Jun 2025 overdue | chronic obstructive pulmonary disease | Istanbul Medeniyet University | Active not recruiting | No outcome recorded |
| — | NCT02790047 Background | Oct 2016 → Jan 2018 | chronic obstructive pulmonary disease | Khon Kaen University | Unknown | No outcome recorded |
| — | NCT01224951 Comparator | Jan 2011 → Feb 2015 | asthma | Universitaire Ziekenhuizen KU Leuven | Unknown | No outcome recorded |
| — | NCT00775489 Comparator | Jan → Jul 2010 | ocular hypertension | University Health Network, Toronto | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-07-31 | Chiesi Farmaceutici S.p.A. | Regulatory Chiesi receives European Marketing Authorisation for its Single Inhaler Triple Therapy delivered via NEXThaler® for the maintenance treatment of Asthma chiesi.com ↗
The EC approval follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in May 2026. |
| 2025-11-26 | Chiesi Farmaceutici S.p.A. | Results Chiesi Advanced Carbon Minimal Inhaler (CMI) Program with New Therapeutic Equivalence Data Presented at British Thoracic Society (BTS) Winter Meeting chiesi.com ↗
The two studies presented at BTS demonstrated therapeutic equivalence and similar safety profiles of Chiesi’s beclometasone dipropionate/ formoterol fumarate product formulated with next generation HFA-152a propellant, compared to the current HFA-134a formulation, in two different strengths 1 . |
| 2017-08-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of QVAR® RediHaler™ (Beclomethasone Dipropionate HFA) Inhalation Aerosol tevapharm.com ↗ |
| 2015-02-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present New Respiratory Data at 2015 Annual Meeting of the American Academy of Allergy, Asthma and Immunology tevapharm.com ↗
Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol Is Effective in Improving Total Nasal Symptom Scores (TNSS) in Children with Perennial Allergic Rhinitis (PAR) Regardless of Baseline Symptom Severity |
| 2014-12-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of QNASL® (Beclomethasone Dipropionate) Nasal Aerosol for Treatment of Children with Seasonal and Perennial Allergic Rhinitis tevapharm.com ↗
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that the U.S. Food and Drug Administration (FDA) approved QNASL® (beclomethasone dipropionate) 40 mcg for the treatment of nasal symptoms associated with allergic rhinitis (AR) in children 4-11 years of age. |
| 2014-11-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents Positive Safety and Efficacy Data for QNASL® (Beclomethasone Dipropionate) Nasal Aerosol in Treating Children with Perennial Allergic Rhinitis tevapharm.com ↗
today announced positive findings from a Phase III clinical study that examined the safety and efficacy of QNASL® (beclomethasone dipropionate) Nasal Aerosol 80 μg/day in children 4-11 years of age with perennial – or “year round” – allergic rhinitis (PAR). |
| 2014-05-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Received FDA Approval for QVAR® (beclomethasone dipropionate HFA) with Dose Counter tevapharm.com ↗ |
| 2014-05-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Acceptance of sNDA Filing for Pediatric Indication for QNASL® (Beclomethasone Dipropionate) Nasal Aerosol tevapharm.com ↗
the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental new drug application (sNDA) for a lower dose QNASL® (beclomethasone dipropionate) Nasal Aerosol |
| 2013-02-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Additional QNASL® (beclomethasone dipropionate) Nasal Aerosol Data to be Presented at Annual Allergy Meeting tevapharm.com ↗
Furthermore, the data also demonstrated nasal symptom relief in patients with SAR and PAR who received treatment with QNASL® 24 hours after dosing. |
| 2012-11-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Phase III Data for Teva’s QNASL® (beclomethasone dipropionate) Demonstrate Efficacy Profile in Pediatric Patients with Seasonal Allergic Rhinitis tevapharm.com ↗
Additional data reported today further support the efficacy of once-daily dosing with QNASL®. |
| 2012-03-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of QNASLTM (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis tevapharm.com ↗ |
| 2012-03-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Results QNASLTM Phase III Data Indicate Investigational Therapy with New Mode of Delivery has Positive Safety and Effective Profile in Treatment of Seasonal and Perennial Allergic Rhinitis tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced positive findings from four Phase III clinical studies that examined the efficacy and safety profile as well as impact on quality of life (QoL) of QNASLTM (beclomethasone dipropionate [BDP]) Nasal Aerosol. |
| 2011-10-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents New Data on QNASL™ at the 2011 American College of Allergy, Asthma and Immunology Annual Meeting tevapharm.com ↗
Findings from one Phase III clinical study being presented demonstrate the degree of patient satisfaction with QNASL™, while the others support the safety and efficacy profile for the product. |
| 2011-08-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives FDA Acceptance of Its New Drug Application for BDP Nasal HFA for the Treatment of Allergic Rhinitis tevapharm.com ↗ |
| 2011-02-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Results from A Phase III Study for QNAZE™ Nasal Aerosol in Perennial Allergic Rhinitis tevapharm.com ↗
Results of the study evaluating patients with PAR showed the once-daily, non-aqueous formulation achieved all primary and secondary efficacy endpoints, demonstrating significantly greater relief of nasal symptoms, including runny nose, nasal congestion, nasal itching and sneezing, compared with placebo. |
| 2010-11-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Highlights QNAZE™ HFA Phase III Data at the 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology tevapharm.com ↗
The results, presented at the 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Phoenix, Ariz., showed that the non-aqueous formulation met all primary and secondary efficacy endpoints, and that the product demonstrated safety similar to placebo. |
| 2009-03-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Study Demonstrates that Qvar® is More Likely to Achieve Successful Asthma Control with Less Exacerbations tevapharm.com ↗
This real life analysis showed that the choice of ICS may impact overall asthma control under actual living conditions, including asthma exacerbation rates. |
All press releases naming this drug 19 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | beclomethasone | “participants will use either a combination of budesonide/formoterol or mometasone/formoterol as both controller and rescue therapy or a stand alone inhaled steroid...” NCT06272370 ↗50“Beclomethasone Dipropionate 100 mcg/Formoterol Fumarate dihydrate 6 mcg/Glycopyrronium Bromide 12.5 mcg in pharmaceutical form aerosol solution in pressurized metered dose...” NCT06234345 ↗ “The study evaluated the efficacy of beclomethasone dipropionate/formoterol fumarate (BDP/FF) extrafine combination versus fluticasone propionate/salmeterol (FP/S) combination...” PMID 24621109 ↗ Mar 2014 “Foster® NEXThaler® (beclomethasone dipropionate 100 µg plus formoterol 6 µg per actuation), 2 inhalations b.i.d. (daily dose of BDP 400 µg plus FF 24 µg)” NCT01570478 ↗ “Any therapy that is prescribed as per asthma guidelines i.e. beclomethasone, budesonide and salbutamol, montelukast etc” NCT06429475 ↗ “a stand alone inhaled steroid (beclomethasone, budesonide, fluticasone, mometasone, ciclesodine) of their choice” NCT07052942 ↗ “Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function” NCT01466712 ↗ “Beclomethasone is a topical corticosteroid that reduces inflammation and provides symptomatic relief in OSF.” NCT06871904 ↗ “Inhaled Fenotereol,Ipratroium Plus Beclomethasone Versus Salmeterol,Tiotropium Plus Fluticasone” NCT05748977 ↗ “inhaled therapy of beclomethasone/formoterol/glycopyrronium (BFG) (100/6/12.5mcg)” NCT04937543 ↗ “Intervention: Drug: Beclomethasone 400 µg HFA per day” NCT03835871 ↗ |
| Known as | BDP | “BACKGROUND: This study evaluated the lung deposition and the distribution pattern in the airways of a fixed combination of beclometasone dipropionate (BDP) and formoterol...” PMID 29989511 ↗ Jul 2018 |
| Known as | Beclometasone | “Lung Deposition of the Dry Powder Fixed Combination Beclometasone Dipropionate Plus Formoterol Fumarate Using NEXThaler(®) Device in Healthy Subjects, Asthmatic Patients, and...” PMID 29989511 ↗ Jul 201811“Triple Therapy (LABA + LAMA + ICS): Patients receive the above combination of LABA and LAMA plus an inhaled corticosteroid (ICS) such as Budesonide, Fluticasone, or Beclometasone.” NCT07058259 ↗ “a corticosteroid (beclometasone) plus a rapid-onset, long-acting β2 agonist (formoterol)” PMID 24321801 ↗ Mar 2013 “beclometasone/formoterol/glycopyrronium 87/5/9 mcg” NCT07329946 ↗ |
| Known as | beclometasone, dipropionate | “BACKGROUND: This study evaluated the lung deposition and the distribution pattern in the airways of a fixed combination of beclometasone dipropionate (BDP) and formoterol...” PMID 29989511 ↗ Jul 20181“Tiotropium 18 µg/dose once daily (handihaler device) + formoterol, fumarate 6µg + beclometasone, dipropionate 100µg / dose (Pressurised inhaler): 2 puffs bid, for one month.” NCT01466712 ↗ |
| Known as | beclometasone/formoterol (100/6µg) pMDI | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00476268 ↗ |
| Known as | beclomethasone (dipropionate) | “formoterol (fumarate dihydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler” NCT03846570 ↗ |
| Known as | Beclomethasone Dipropionate,BDP | “Beclomethasone Dipropionate,BDP” NCT02526758 ↗ |
| Known as | QVAR | “Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)” NCT01373008 ↗1“beclomethasone/QVAR, or budesonide/Pulmicort” NCT06272370 ↗ |
| Known as | QVAR 80 HFA | “The treatment with inhaled beclomethasone will be administered to Group A from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of...” NCT00532584 ↗1“The treatment with inhaled beclomethasone will be administered to Group A from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of...” NCT00826748 ↗ |
| Modality | Small molecule | “Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection” NCT02351180 ↗ |
| Route | Inhaled | “To test if inhaled glucocorticoids, early in the course of respiratory failure in premature infants, permit normal lung growth and differentiation” NCT00000576 ↗ |