Tracleer (bosentan) / J&J, Roche 
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 135 Diseases   28 Trials   28 Trials   1184 News 


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  • ||||||||||  sildenafil / Generic mfg., methotrexate / Generic mfg., Tracleer (bosentan) / J&J, Roche
    [VIRTUAL] A new method to estimate the long-term effect of immunosuppressants and vasodilator therapies on lung function outcomes in systemic sclerosis patients (Pre-congress content) -  Jul 15, 2020 - Abstract #ERS2020ERS_2091;    
    A positive and stable treatment effect could only be expected during the first 20 years from the time of diagnosis. 2) Vasodilators have greater effect on TLC and TLCO than Immunosupressor (0.048 vs -0.034 for TLC, -0.06 vs -0.17 for TLCO); while Immunosupressor's averaged effect was better on Spirometry outcome (0.07 vs -0.01 for FVC ) Conclusion : The debiasing machine learning framework is a promising method for the optimisation of personalized therapies in chronic lung diseases.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Trial completion date, Trial primary completion date:  MoD: Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Jul 13, 2020   
    P3,  N=100, Not yet recruiting, 
    2) Vasodilators have greater effect on TLC and TLCO than Immunosupressor (0.048 vs -0.034 for TLC, -0.06 vs -0.17 for TLCO); while Immunosupressor's averaged effect was better on Spirometry outcome (0.07 vs -0.01 for FVC ) Conclusion : The debiasing machine learning framework is a promising method for the optimisation of personalized therapies in chronic lung diseases. Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2026
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Enrollment closed, Trial completion date, Trial primary completion date:  End-Stress: Endothelin Receptor Function and Acute Stress (clinicaltrials.gov) -  Jul 9, 2020   
    P=N/A,  N=320, Active, not recruiting, 
    Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2026 Recruiting --> Active, not recruiting | Trial completion date: Apr 2020 --> Sep 2020 | Trial primary completion date: Apr 2020 --> Sep 2020
  • ||||||||||  [VIRTUAL] Delayed Diagnosis of Alveolar Capillary Dysplasia with Misalignment of the Pulmonary Vein in a Term Infant (ATS 2020 Virtual) -  Jul 6, 2020 - Abstract #ATSI2020ATS-I_5735;    
    She was started on sildenafil, treprostinil, diuretics, and a five-day course of methylprednisolone (2 mg/kg/day)...During her third admission at sixteen months of age, she was intubated for acute respiratory failure and had refractory pulmonary hypertension despite iNO, iloprost, treprostinil, bosentan, and sildenafil...Broad phenotypic differences have been reported for other FOXF1 mutations. Given her mild presentation and relatively prolonged survival, this variant may be characterized by a less severe presentation but no less fatal outcome.
  • ||||||||||  sildenafil / Generic mfg., Tracleer (bosentan) / J&J, Roche, tadalafil / Generic mfg.
    [VIRTUAL] Novel Intronic TBX4 Mutation Associated with Lung Disease, Pulmonary Arterial Hypertension and Skeletal Abnormalities with Variable Penetrance in a Single Family (ATS 2020 Virtual) -  Jul 6, 2020 - Abstract #ATSI2020ATS-I_3337;    
    He was treated with inhaled nitric-oxide and later transitioned to sildenafil...Over the subsequent 2 years, his lung disease progressed; most recent follow-up (at age 5) was notable for a 4L oxygen requirement and moderate-severe pulmonary arterial hypertension requiring tadalafil and bosentan...Neither the patient's mother nor older sister carried the TBX4 variant; both were healthy and did not have skeletal or respiratory findings. Our study characterizes a novel intronic variant in TBX4 associated with pulmonary hypertension, a lung development disorder, and limb abnormalities in a single family with variable penetrance.
  • ||||||||||  Opsumit (macitentan) / Nippon Shinyaku, J&J, Tracleer (bosentan) / J&J, Roche
    Journal:  Bosentan or Macitentan Therapy in Chronic Thromboembolic Pulmonary Hypertension? (Pubmed Central) -  Jul 4, 2020   
    Our study characterizes a novel intronic variant in TBX4 associated with pulmonary hypertension, a lung development disorder, and limb abnormalities in a single family with variable penetrance. CTEPH patients receiving bosentan or macitentan have improved clinical outcomes till 2-year follow-up, without significant differences in outcomes between both therapies.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Journal:  Biventricular repair of double-outlet right ventricle with noncommitted ventricular septal defect using intraventricular conduit. (Pubmed Central) -  Jun 25, 2020   
    The new model holds considerable potential for future, more complex analyses, when emerging experimental data may enable modelling of membrane transport mechanisms. Biventricular repair with intraventricular conduit is a relatively simple and safe procedure for patients aged more than 2 years with double-outlet right ventricle with noncommitted ventricular septal defect, with excellent early and midterm outcomes.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Journal:  From an innocent heart murmur to pulmonary arterial hypertension. (Pubmed Central) -  Jun 9, 2020   
    Currently, pulmonary arterial hypertension persists, for which Bosentan (Actelion, USA) has been implemented as a long-term treatment...Therefore, it has become an essential diagnostic tool to reduce morbidity and mortality. Although the surgical correction of congenital heart disease with pulmonary arterial hypertension is feasible in some patients, its subsequent management is complex and has an adverse impact on the quality of life.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    [VIRTUAL] THE IMMUNOMODULATORY AND ANTI-INFLAMMATORY EFFECTS OF BOSENTAN IN SYSTEMIC SCLEROSIS () -  May 22, 2020 - Abstract #EULAR2020EULAR_1963;    
    The observed difference response to therapy between the two cohorts of patients was attributed to influence of ET-1 levels on the relative expression of ET-1 receptors on immune cells surface. Interestingly Bosentan, beside the already-known effect on promoting antigen presenting cells apoptosis, seem to exert its immunomodulatory activity also by deregulating functions that mainly involves the T cells and by promoting their apoptosis, which in turn reflect also its anti-inflammatory proprieties.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Trial suspension:  BOSRET: Safety of Bosentan in Type II Diabetic Patients (clinicaltrials.gov) -  May 21, 2020   
    P1,  N=22, Suspended, 
    Interestingly Bosentan, beside the already-known effect on promoting antigen presenting cells apoptosis, seem to exert its immunomodulatory activity also by deregulating functions that mainly involves the T cells and by promoting their apoptosis, which in turn reflect also its anti-inflammatory proprieties. Recruiting --> Suspended
  • ||||||||||  oxaliplatin / Generic mfg.
    Preclinical, Journal:  Involvement of Endothelin Receptors in Peripheral Sensory Neuropathy Induced by Oxaliplatin in Mice. (Pubmed Central) -  May 15, 2020   
    Moreover, bosentan prevented mechanical and thermal hypersensitivity in oxaliplatin-treated mice (P < 0.05). In conclusion, both endothelin ET and ET receptors seem to be involved in the OIN in mice and they should be considered possible targets for the management of this clinical feature.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Preclinical, Journal:  The effects of bosentan on hyperoxia-induced lung injury in neonatal rats. (Pubmed Central) -  May 7, 2020   
    Nonetheless, PAH pharmacotherapy should generally be avoided for most patients with PH-LHD. This experimental study showed that bosentan had a protective effect on hyperoxic lung injury through its anti-inflammatory properties.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Trial completion date, Trial initiation date, Trial primary completion date:  MoD: Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Apr 9, 2020   
    P3,  N=100, Not yet recruiting, 
    Mean total costs were higher with endothelin receptor antagonists than phosphodiesterase type-5 inhibitors in all patients ($91,328 versus $72,401, P = 0.0003) and in adherent patients ($88,867 versus $56,300, P < 0.0001), driven by higher drug costs. Trial completion date: Dec 2024 --> Dec 2025 | Initiation date: Apr 2020 --> Jul 2021 | Trial primary completion date: Dec 2024 --> Dec 2025
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Trial completion, Trial completion date, Surgery:  Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension (clinicaltrials.gov) -  Mar 30, 2020   
    P=N/A,  N=50, Completed, 
    In the SSc group, limb salvage rate tended to be higher than in the non-SSc group. Recruiting --> Completed | Trial completion date: Dec 2016 --> Mar 2020
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Trial termination, FDG PET:  Bosentan in Myocardium Metabolism and Perfusion Measured by 18F-FDG and 82Rb PET/CT on PAH and CTEPH (clinicaltrials.gov) -  Mar 23, 2020   
    P=N/A,  N=2, Terminated, 
    Altogether, the results suggest that zinc deficiency up-regulates ET-1 signaling through HIF-1 activation and stimulates endothelial cell migration suggesting an important role of zinc in the vascular consequences of IH and OSA mediated by the HIF-1-ET- signaling. Completed --> Terminated; Slow patient recruitment after arrival of macitentan on the market
  • ||||||||||  Review, Journal:  Endothelin Receptor Antagonists: Status Quo and Future Perspectives for Targeted Therapy. (Pubmed Central) -  Mar 23, 2020   
    Treatment with approved endothelin receptor antagonists (ERAs), such as bosentan, ambrisentan, or macitentan, slow down PAH progression and relieves symptoms...Furthermore, in the SONAR (Study Of Diabetic Nephropathy With Atrasentan) trial, the selective ERA atrasentan reduced the risk of renal events in patients with diabetes and chronic kidney disease...Preclinical studies regarding heart failure, cancer, and fibrotic diseases have demonstrated promising effects, but clinical trials have not yet produced measurable results. Nevertheless, the potential benefits of ERAs may not be fully realized.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Enrollment open:  BOSRET: Safety of Bosentan in Type II Diabetic Patients (clinicaltrials.gov) -  Mar 17, 2020   
    P1,  N=22, Recruiting, 
    Nevertheless, the potential benefits of ERAs may not be fully realized. Not yet recruiting --> Recruiting