An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation

The goal of this research study is to test the efficacy of a novel immunosuppressive agent, belumosudil, in allogeneic hematopoietic stem cell transplant (HSCT) recipients who have been newly diagnosed or have developing (early stage) bronchiolitis obliterans syndrome (BOS).
The name of the study drugs involved in this study are:
Belumosudil (an immunotherapy)
Fluticasone (an intranasal corticosteroid)
Azithromycin (an antibiotic)
Montelukast (a leukotriene receptor antagonist)
Prednisone (a corticosteroid)

Start Date31 May 2024

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+2]

NCT06290102 / RecruitingPhase 1

An Open Label, Single Dose, 3-Period, Crossover Study to Determine the Pharmacokinetic Profile and Safety of Fluticasone Propionate/Albuterol Sulfate (Fp/ABS) Multidose Dry Powder Inhaler With e-Module (eMDPI) Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Participants With Asthma (4 to 11 Years Old)

The primary objectives of this study are:
To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module [Fp/ABS eMDPI]) in participants with asthma
To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI)
To compare the PK profiles of ABS between the 2 different strengths of TEV-56248
The secondary objective is:
• To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI

Start Date07 May 2024

Sponsor / Collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

CTR20241831 / RecruitingNot Applicable

丙酸氟替卡松乳膏的人体生物等效性研究

[Translation] Study on the bioequivalence of fluticasone propionate cream in healthy volunteers

1、以健康受试者为研究对象，以参比制剂丙酸氟替卡松乳膏（商品名：Cutivate®，规格：0.05% 15g:7.5mg/支，GlaxoSmithKline (Ireland) Limited公司持证）为试验用药，通过观测收缩皮肤血管，致使皮肤变白的作用，探索达到半数最大效应（Emax）的剂量持续时间（ED50）；2、以健康受试者为研究对象，通过观测皮肤血管收缩，比较受试制剂丙酸氟替卡松乳膏（规格：0.05% 15g:7.5mg/支，浙江仙琚制药股份有限公司）与参比制剂丙酸氟替卡松乳膏（商品名：Cutivate®，规格：0.05% 15g:7.5mg/支，GlaxoSmithKline (Ireland) Limited公司持证）致使皮肤变白的作用，评价受试制剂与参比制剂是否具有生物等效性。

[Translation]

1. Healthy subjects were used as research subjects, and the reference preparation fluticasone propionate cream (trade name: Cutivate®, specification: 0.05% 15g: 7.5mg/tube, licensed by GlaxoSmithKline (Ireland) Limited) was used as the test drug. The effect of contracting skin blood vessels and causing skin whitening was observed to explore the dose duration (ED50) that reaches the half-maximal effect (Emax); 2. Healthy subjects were used as research subjects. The skin whitening effect of the test preparation fluticasone propionate cream (specification: 0.05% 15g: 7.5mg/tube, Zhejiang Xianju Pharmaceutical Co., Ltd.) and the reference preparation fluticasone propionate cream (trade name: Cutivate®, specification: 0.05% 15g: 7.5mg/tube, licensed by GlaxoSmithKline (Ireland) Limited) was compared by observing skin vasoconstriction to evaluate whether the test preparation and the reference preparation are bioequivalent.

Start Date20 Apr 2024

Sponsor / Collaborator

Zhejiang Xianju Pharmaceutical Co., Ltd.

100 Clinical Results associated with Fluticasone Propionate

100 Translational Medicine associated with Fluticasone Propionate

100 Patents (Medical) associated with Fluticasone Propionate

4,057

Literatures (Medical) associated with Fluticasone Propionate

01 Mar 2024·Advances in therapy

Effect of Individual Patient Characteristics and Treatment Choices on Reliever Medication Use in Moderate-Severe Asthma: A Poisson Analysis of Randomised Clinical Trials

Article

Author: Yorgancıoğlu, Arzu ; Majumdar, Anurita ; Pitrez, Paulo M ; Della Pasqua, Oscar ; Brusselle, Guy ; Fumali, Sourabh ; Oosterholt, Sean ; van Dijkman, Sven C ; Pavord, Ian

INTRODUCTION:

Even though increased use of reliever medication, including short-acting beta agonists (SABA), provides an indirect measure of symptom worsening, there have been limited efforts to assess how different patterns of reliever use correlate with symptom control and future risk of exacerbations. Here, we evaluate the effect of individual baseline characteristics on reliever use in patients with moderate-severe asthma on regular maintenance therapy with fluticasone propionate (FP) or combination therapy with fluticasone propionate/salmeterol (FP/SAL) or budesonide/formoterol (BUD/FOR).

METHODS:

A drug-disease model describing the number of 24-h puffs and overnight occasions was developed with data from five clinical studies (N = 6212). The model was implemented using a nonlinear mixed effects approach and a Poisson function, considering clinical and demographic baseline characteristics. Goodness of fit and model predictive performance were assessed. Heatmaps were created to summarise the effect of concurrent baseline factors on reliever utilisation.

RESULTS:

The final model accurately described individual patterns of reliever use, which is significantly increased with time since diagnosis, smoking, higher Asthma Control Questionnaire (ACQ-5) score and higher body mass index (BMI) at baseline. Whilst the number of puffs decreases slowly after an initial drop relative to the start of treatment, exacerbating patients utilise significantly more reliever than those who do not exacerbate. The mean effect of FP/SAL (median dose: 250/50 μg BID) on reliever use was slightly higher than that of BUD/FOR (median dose: 160/4.5 μg BID), i.e. a 75.3% vs 69.3% reduction in reliever use, respectively.

CONCLUSIONS:

The availability of individual-level patient data in conjunction with a parametric approach enabled the characterisation of interindividual differences in the patterns of reliever use in patients with moderate-severe asthma. Taken together, individual demographic and clinical characteristics, as well as exacerbation history, can be considered an indicator of the degree of asthma control. High SABA reliever use suggests suboptimal clinical management of patients on maintenance therapy.

01 Feb 2024·Expert review of clinical pharmacology

Comparative effectiveness and safety of inhaled corticosteroid plus long-acting β ₂ -agonist fixed-dose combinations vs. long-acting muscarinic antagonist in bronchiectasis

Article

Author: Chou, Yueh-Ching ; Chou, Chian-Ying ; Hsu, Chia-Chen ; Chang, Yuh-Lih ; Su, Vincent Yi-Fong ; Hwang, Hsuen-En ; Ding, Ting-Lin

BACKGROUND:

This study aimed to evaluate the effectiveness and safety of fixed-dose combination (FDC) inhaled corticosteroids/long-acting β₂-agonists (ICS/LABA) in bronchiectasis.

RESEARCH DESIGN AND METHODS:

A retrospective cohort study analyzed electronic medical records of bronchiectasis patients initiating ICS/LABA FDC or LAMA between 2007 and 2021. All bronchiectasis diagnoses were made by radiologists using high-resolution computed tomography.

RESULTS:

Of the 1,736 patients, 1,281 took ICS/LABA FDC and 455 LAMA. Among the 694 propensity score matched patients, ICS/LABA FDC had comparable outcomes to LAMA, with HRs of 1.22 (95% CI 0.81-1.83) for hospitalized respiratory infection, 1.06 (95% CI 0.84-1.33) for acute exacerbation, and 1.06 (95% CI 0.66-1.02) for all-cause hospitalization. Beclomethasone/formoterol (BEC/FOR) or budesonide/formoterol (BUD/FOR) led to a lower risk of acute exacerbation compared to fluticasone/salmeterol (FLU/SAL) (BEC/FOR HR 0.59, 95% CI 0.43-0.81; BUD/FOR HR 0.68, 95% CI 0.50-0.93). BEC/FOR resulted in lower risks of hospitalized respiratory infection (HR 0.48, 95% 0.26-0.86) and all-cause hospitalization (HR 0.55, 95% 0.37-0.80) compared to FLU/SAL.

CONCLUSION:

Our findings provide important evidence on the effectiveness and safety of ICS/LABA FDC compared with LAMA for bronchiectasis. BEC/FOR and BUD/FOR were associated with better outcomes than FLU/SAL.

01 Feb 2024·Drug metabolism and pharmacokinetics

Quantification of fluticasone propionate in human plasma by LC–MS/MS and its application in the pharmacokinetic study of nasal spray at clinical doses

Article

Author: Furihata, Tomomi ; Adachi, Rena ; Yokokawa, Akitomo ; Shibasaki, Hiromi ; Yamagata, Aya

We developed a method for quantifying fluticasone propionate (FP) using general-purpose liquid chromatography-tandem mass spectrometry equipment to measure the plasma concentration of FP for the pharmacokinetic study of FP following the administration of a prescribed nasal spray dose (100 μg). Using ammonium acetate (0.01 M)-formic acid (pH 2.9; 499:1, v/v) and methanol as the mobile phase, 3 pg/mL of FP was quantified. The relative error and standard deviation of the lower limit of quantification were <3.1%. The intra- and interday assay reproducibility was <3.5%. After 15 min of administering 200 μg FP nasal spray as the first dose, the FP concentration detected in the plasma of the two participants was 3.99 and 3.69 pg/mL. Subsequent doses of 100 μg FP were administered twice daily. The area under the plasma concentration-time curve values after 8-10 days of repeated administration of 100 μg of FP were approximately 1.6-fold higher than those achieved following a single administration of 200 μg of FP, which confirmed drug accumulation. The bioavailability of nasal FP was estimated to be 2% and 4%. This knowledge might help in reducing anxiety among patients who avoid using FP nasal spray, fearing its adverse effects.

133

News (Medical) associated with Fluticasone Propionate

27 Jun 2024

·www.globenewswire.com

Expanded Access to XHANCE with Addition to National Commercial Formularies

YARDLEY, Pa., June 27, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that XHANCE® (fluticasone propionate) has been added to Express Scripts’ national formularies, including the National Preferred, Flex, and Basic formularies, among the largest commercial formularies in the U.S. with more than 24 million lives. “XHANCE is approved for treatment of chronic rhinosinusitis and, importantly, is the only medication approved for by far the most common type - without nasal polyps, so we are very pleased that Express Scripts has added XHANCE as a preferred option to these formularies,” said Ramy Mahmoud, MD, MPH, CEO of Optinose. “Our recently published landmark studies in chronic sinusitis, and the recent FDA approval, mark a breakthrough for doctors and patients who want safe and effective treatment for one the most common diagnoses in adult outpatient medicine. We look forward to seeing the addition of XHANCE to these Express Scripts national formularies result in increased patient access to the only evidence-based prescription treatment for this disease.” Chronic sinusitis (also referred as chronic rhinosinusitis) affects approximately 30 million adults in the United States. Research shows that the disease impairs quality of life to a similar degree as other serious chronic conditions, such as chronic obstructive pulmonary disease, sciatica, or migraine. The ReOpen clinical trial program was the first ever controlled trial program we are aware of to demonstrate significant improvement in both symptoms and inflammation inside the sinuses for patients with chronic sinusitis, regardless of whether nasal polyps are present, and to demonstrate significant reduction in the number of acute exacerbations.1 About OptinoseOptinose is a specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. To learn more, please visit www.optinose.com or follow us on X and LinkedIn. About XHANCEXHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also referred to as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for both the treatment of chronic rhinosinusitis without nasal polyps (also called chronic sinusitis) and chronic rhinosinusitis with nasal polyps (also called nasal polyps) in patients 18 years of age or older. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE. WARNINGS AND PRECAUTIONS: Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.Immunosuppression and infections can occur, including potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.Assess for decrease in bone mineral density initially and periodically thereafter. ADVERSE REACTIONS: Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, headache, and nasopharyngitis.Chronic rhinosinusitis with nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects.USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure.Please see full Prescribing Information, including Instructions for Use References James N. Palmer, Nithin D. Adappa, Rakesh K. Chandra, Greg E. Davis, Mahboobeh Mahdavinia, John Messina, Randall A. Ow, Zara M. Patel, Anju T. Peters, Harry Sacks, Rodney J. Schlosser, Raj Sindwani, Zachary M. Soler, Andrew A. White, Sarah K. Wise, Ramy A. Mahmoud, Efficacy of EDS-FLU for Chronic Rhinosinusitis: Two Randomized Controlled Trials (ReOpen1 and ReOpen2), The Journal of Allergy and Clinical Immunology: In Practice, Volume 12, Issue 4, 2024, Pages 1049-1061, ISSN 2213-2198, https://doi.org/10.1016/j.jaip.2023.12.016. (https://www.sciencedirect.com/science/article/pii/S221321982301365X) Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to the benefits of XHANCE for the treatment of chronic sinusitis (also called chronic rhinosinusitis) with and without nasal polyps; the potential for XHANCE to become a preferred option for the treatment of chronic sinusitis; the benefits of XHANCE being added to the Express Scripts’ national formularies; the benefits of the Exhalation Delivery System; and other statements regarding the Company's future operations, prospects, objectives, and other future events. Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: physician and patient acceptance of XHANCE for its new indication (treatment of adults with chronic rhinosinusitis without nasal polyps); the Company’s ability to maintain adequate third party reimbursement for XHANCE (including its new indication); potential for varying interpretation of clinical trial results of XHANCE; the prevalence of chronic sinusitis and market opportunities for XHANCE may be smaller than the Company expects; and the risks, uncertainties and other factors discussed under the caption "Item 1A. Risk Factors" and elsewhere in our most recent Form 10-K and Form 10-Q filings with the Securities and Exchange Commission - which are available at www.sec.gov. As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and we undertake no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise. Optinose Investor ContactJonathan Neelyjonathan.neely@optinose.com267.521.0531

Drug ApprovalClinical Study

24 Jun 2024

·www.echemi.com

Respiratory Diseases Market Sees New Opportunities

Respiratory diseases, as a major challenge in the field of global public health, have always been the focus of the global medical community and the public. Among them, asthma and chronic obstructive pulmonary disease (COPD) as the two main types, not only affect billions of patients, but also bring a huge medical burden. However, with the deepening of medical research and the progress of science and technology, this field is ushering in unprecedented development opportunities. Traditional respiratory disease treatment methods, such as bronchodilation and anti-inflammatory treatment, can significantly alleviate the symptoms of patients in the short term, but often find it difficult to fundamentally solve the problem of chronic inflammation. Fortunately, with the in-depth study of the pathogenesis of the disease, especially the deepening understanding of the Th2 cell-mediated airway inflammation mechanism, we are now able to treat the root cause of the disease more accurately. For example, a number of targeted biological agents targeting inflammatory mediators such as IL-5 and IL-4/13 have been successively approved for marketing, providing new hope for patients with refractory asthma. These new drugs not only can more effectively control inflammation, but also reduce the side effects of traditional drugs, and improve the quality of life of patients. In the field of COPD treatment, there are also exciting developments. With the deeper understanding of the pathogenesis of COPD, new drug development has also made significant breakthroughs. For example, Brensocatib, a new drug from Insmed, has achieved success in phase 3 clinical trials. These new drugs not only can alleviate the symptoms of COPD patients, but also can improve lung function and quality of life. This breakthrough has undoubtedly brought new treatment options for COPD patients and new growth points for the respiratory disease market. However, with the expiration of patents, some well-established star drugs are facing fierce competition from generic drugs. Taking AstraZeneca's budesonide/formoterol and GlaxoSmithKline's salmeterol/fluticasone combination products as examples, these drugs have been the leaders in the respiratory disease market in recent years. However, with the expiration of patents, the influx of generic drugs has made the market competition increasingly fierce, and the sales of these well-established drugs have also shown a downward trend. This also means that the respiratory disease field will usher in a new round of reshuffle in the future. For pharmaceutical companies, this is undoubtedly a challenge. However, challenges and opportunities coexist. With the continuous deepening of disease awareness and the continuous enrichment of treatment methods, the respiratory disease market is showing vigorous vitality. In order to establish a foothold in this market, pharmaceutical companies need to continuously introduce innovative products and explore new treatment ideas. At the same time, they also need to respond reasonably to market competition after the expiration of patents, and maintain competitive advantages through improving product quality and reducing production costs. In addition, with the application of technologies such as big data and artificial intelligence, the treatment of respiratory diseases will also become more accurate and efficient. By analyzing patient data, doctors can more accurately determine the type and severity of the disease, and develop personalized treatment plans for patients. This will greatly improve the treatment effect, reduce medical costs, and bring better treatment experience for patients. In summary, the field of respiratory diseases is ushering in unprecedented development opportunities. Both internal and external companies in the industry should closely monitor market dynamics and technological progress, seize opportunities, and jointly promote the sustainable development of this field. In the future, we have reason to believe that the treatment of respiratory diseases will become more accurate, efficient and humanized.

Phase 3Drug ApprovalClinical Result

12 Jun 2024

·www.biospace.com

Teva Loses Inhaler Patent Case Against Amneal, Must Delete or Amend Orange Book Listing

Pictured: Facade of a U.S. courthouse/iStock, PierreDesrosiers A New Jersey federal court on Monday ruled against Teva Pharmaceuticals, finding that five key patents for its inhaler product ProAir HFA (albuterol sulfate) are “improperly listed” on the FDA’s Orange Book. District Judge Stanley Chesler agreed with the plaintiffs—Amneal Pharmaceuticals, with the backing of the FTC—that Teva’s patents only apply to the inhaler device of ProAir HFA and not to its albuterol sulfate drug formulation. The judge ruled that Teva’s inhaler patents do not claim a “finished dosage form” of albuterol, allowing Amneal to develop a generic version of the drug. “It is undisputed that no claim in any of the Inhaler Patents discloses albuterol sulfate,” Chesler wrote in his decision, adding that Teva must either “correct or delete” its patent listings in the FDA’s Orange Book to reflect the court’s judgement. Amneal in July 2023 submitted an Abbreviated New Drug Application (ANDA) for a generic version of ProAir HFA, though its filing specifically focused on inhalable albuterol sulfate. Teva in 2023 sued Amneal, claiming that the ANDA infringed on its patent protection for its drug-device combination product. Amneal filed a countersuit soon after claiming that Teva’s patents should not have been listed on the Orange Book in the first place. Teva’s lawsuit focuses on five key patents, dubbed the ‘712, ‘289, ‘587, ‘808 and ‘889 patents. Together, these patents protect aspects of Teva’s inhaler device and its metered dose system. However, in its suit, the pharma sought to expand this coverage to also include the albuterol formulation that the inhaler delivers. In his opinion, Chesler agreed with Teva that the term “drug” has a “broad scope” and could include devices or other components “intended for use for the treatment of disease.” However, the Orange Book’s listing statute modifies this definition with the restrictive phrase “for which the applicant submitted the application,” which Chesler argues nullifies Teva’s argument. “The fact that the statutory definition of ‘drug’ expressly includes devices for treating disease, and their components, does not nullify the restrictive action of the modifying phrase, ‘for which the applicant submitted the application,’” Chesler wrote. Monday’s ruling comes as the FTC is ramping up its scrutiny of “junk” patents listed on the FDA’s Orange Book. The antitrust watchdog launched its initial salvo in November 2023, challenging more than 100 patents by companies including AbbVie, GSK and Teva. The FTC’s opening campaign included a wide range of pharmaceutical products, including autoinjectors and inhalers. In April 2024, the FTC sent a warning letter to Novo Nordisk calling into question the patent of its blockbuster diabetes drug Ozempic (semaglutide). The federal agency also wrote to GSK to raise concerns about its asthma inhaler Trelegy Ellipta (fluticasone, umeclidinium, vilanterol). Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Patent Infringement

100 Deals associated with Fluticasone Propionate

External Link

KEGG	Wiki	ATC	Drug Bank
D01708	Fluticasone Propionate	R03BA05 D07AC17 R01AD08	DB00588

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Chronic sinusitis	US	OptiNose US, Inc.	15 Mar 2024
Nasal Obstruction	US	Haleon US Capital LLC	23 Jul 2014
Sneezing	US	Haleon US Capital LLC	23 Jul 2014
Dermatitis, Atopic	US	Fougera Pharmaceuticals, Inc.	31 Mar 2005
Dermatitis, Contact	JP	GSK Plc	02 Oct 2001
Dermatitis, Seborrheic	JP	GSK Plc	02 Oct 2001
Eczema	JP	GSK Plc	02 Oct 2001
Erythema	JP	GSK Plc	02 Oct 2001
Lichen Planus	JP	GSK Plc	02 Oct 2001
Lupus Erythematosus, Discoid	JP	GSK Plc	02 Oct 2001
Nasal Polyps	JP	GSK Plc	02 Oct 2001
Neurodermatitis	JP	GSK Plc	02 Oct 2001
Prurigo	JP	GSK Plc	02 Oct 2001
Pruritus	JP	GSK Plc	02 Oct 2001
Psoriasis	JP	GSK Plc	02 Oct 2001
Asthma	US	GSK Plc	27 Mar 1996
Anaphylaxis	US	Haleon US Capital LLC	19 Oct 1994
Rhinitis	US	Haleon US Capital LLC	19 Oct 1994
Rhinitis, Allergic	JP	GlaxoSmithKline KK	01 Jul 1994
Rhinitis, Vasomotor	JP	GlaxoSmithKline KK	01 Jul 1994

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic rhinosinusitis with nasal polyps	Phase 3	US	OptiNose, Inc.	01 Sep 2013
Multiple Hamartoma Syndrome	Phase 3	US	OptiNose, Inc.	01 Sep 2013
Rhinitis, Allergic, Seasonal	Phase 3	US	GSK Plc	01 Dec 2012
Severe asthma	Phase 3	CN	Glaxosmithkline Australia Pty Ltd.	27 Sep 2012
Severe asthma	Phase 3	CN	GlaxoSmithKline (China) Investment Co., Ltd.	27 Sep 2012
Asthma, Exercise-Induced	Phase 3	-	GSK Plc	01 Jan 2012
Persistent asthma	Phase 3	US	GSK Plc	01 Feb 2007
Persistent asthma	Phase 3	AU	GSK Plc	01 Feb 2007
Persistent asthma	Phase 3	CA	GSK Plc	01 Feb 2007
Persistent asthma	Phase 3	CL	GSK Plc	01 Feb 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01966692 (CTgov)	Phase 1	Asthma	24	Fluticasone Propionate (Fluticasone Propionate Formulation 1 (A-4.5 µm))	ftxttcnhnm(qtjrniwqbh) = mglqjxhegs eispreqvkd (toajrzqhbk, tgbtkqlczu - zycvltevor) View more	-	06 May 2024
				Fluticasone Propionate (Fluticasone Propionate Formulation 2 (B-3.8 µm))	ftxttcnhnm(qtjrniwqbh) = fsqiswdyjm eispreqvkd (toajrzqhbk, gihepfbfhw - xkzhgswydo) View more
NCT03960580 (CTgov)	Phase 3	Chronic sinusitis \| Nasal Polyps	223	OPN-375 (Placebo)	tcayryvjyi(jtzywrqckg) = qxgrgorbsv sdjupmibef (oclyxyztzg, iraaabkvuk - wxczmxbzct) View more	-	21 Dec 2023
				OPN-375 (OPN-375 186 μg BID)	tcayryvjyi(jtzywrqckg) = baqurooson sdjupmibef (oclyxyztzg, poekfwznvk - wmfhgsqpkh) View more
NCT03781804 (CTgov)	Phase 3	Nasal Polyps \| Chronic sinusitis	332	OPN-375 (OPN-375 186 μg BID)	hymfvqfkyu(hrxurfdqvu) = xpfxxtxtgb hrxmdgynze (incrpacnkz, cjqlledqbu - alkexczigf) View more	-	18 Sep 2023
				OPN-375 (OPN-375 372 μg BID)	hymfvqfkyu(hrxurfdqvu) = jbirhcouxq hrxmdgynze (incrpacnkz, rexnsdonmu - zbrykzkmfh) View more
NCT04120402 (EP-104IAR-201, Biospace) Manual	Phase 2	Osteoarthritis	318	EP-104IAR	lqogwdisjp(mbbxgvafpg): P-Value = 0.004 Met View more	Positive	26 Jun 2023
				placebo
NCT02246920 (CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	1,474	Fluticasone propionate (Investigational Test Product)	aqkmaqnsaj(hwuductfxp) = tdcdxdjvur cacwmkjcqe (qqvmqvytld, wouybiafzq - fgllsjtrvr) View more	-	08 Jun 2023
				Flonase® (Reference Listed Drug)	aqkmaqnsaj(hwuductfxp) = oiokbkztxg cacwmkjcqe (qqvmqvytld, upcczweamc - ejtmuyvlcy) View more
NCT03926026 (CTgov)	Phase 2	Blepharitis	36	Fluticasone Propionate (NCX 4251 QD)	safyzlgcnw(rkratixhjo) = qlagkhhqhv xotxbizvdi (erasfuetue, vvglxknzvv - dbukcohzki) View more	-	19 Jan 2023
				Placebo (Placebo QD)	safyzlgcnw(rkratixhjo) = qdluhrapdx xotxbizvdi (erasfuetue, ruuizaxjvc - ywgmykkrfg) View more
NCT04675242 (CTgov)	Phase 2	Blepharitis	224	NCX 4251 (NCX 4251)	ldvcxyuvta(qldjrrxpak) = yimxztmuus yrxmgjayqu (fzzmbsseag, dobrcwslip - bxynuwofdz) View more	-	14 Dec 2022
				Placebo (Placebo)	ldvcxyuvta(qldjrrxpak) = moamrkbnwh yrxmgjayqu (fzzmbsseag, fcikpkjalb - qinbovlojd) View more
NCT03191864 (FLUTE, Pubmed) Manual	Phase 2	Eosinophilic Esophagitis	106	APT-1011	ggdjbmydsy(ehfhpuojjy) = Histologic response rates were 0% for placebo, 80% for APT-1011 3 mg twice daily (BID), 67% for 3 mg at bedtime (HS), 86% for 1.5 mg BID, 48% for 1.5 mg HS emqrcssfhp (jvtqezbnhx ) View more	Positive	15 Feb 2022
				Placebo
NCT03756883 (CTgov)	Phase 3	Asthma	999	fluticasone propionate+Salmeterol Inhalation Powder (Test)	wxjykmxnnv(dkelmcvcmj) = bhvrapdzgj ciliupsmum (dkaoewbxwd, mgwrjubivd - rwlreqhqhi) View more	-	24 Sep 2021
				fluticasone propionate+Salmeterol Inhalation Powder (Reference)	wxjykmxnnv(dkelmcvcmj) = txzxeujdcr ciliupsmum (dkaoewbxwd, uqurdolqim - jyhcmgonbx) View more
NCT02740543 (CTgov)	Phase 2	Allergic asthma	18	Fluticasone propionate HFA 220 (Allergic Asthma (AA))	fowdusjkdy(keakbbgqfd) = fbjrougden fafjuadowd (bbspsfdvyu, obttibsgiq - hsbsdwevtf) View more	-	13 Sep 2021
				fluticasone propionate HFA (Control)	fowdusjkdy(keakbbgqfd) = suioiruogj fafjuadowd (bbspsfdvyu, kplvitixzq - fjyckvhopg) View more

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