Ultibro (glycopyrronium/indacaterol) / Novartis 
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 8 Diseases   7 Trials   7 Trials   265 News 


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  • ||||||||||  Ultibro (glycopyrronium/indacaterol) / Novartis
    Unilateral pulmonary hypoplasia presenting as respiratory failure in a 47 year old man with pulmonary tuberculosis () -  Nov 5, 2024 - Abstract #APSR2024APSR_349;    
    The patient is currently receiving HRZE treatment and Glycopyrronium + Indacaterol inhaler for PTB, bacteriologically confirmed and COPD, respectively...Compensatory contralateral lung hyperinflation was noted and strengthens congenital etiology.2 Previous studies showed obstructive airway pathology, he presented in respiratory failure with respiratory acidosis, and was managed as such with good clinical response.3 Tuberculosis was noted on bronchial washing and treated. Patient was maintained on LABA+LAMA.
  • ||||||||||  Ultibro (glycopyrronium/indacaterol) / Novartis
    18 ADMISSIONS WEREN () -  Aug 27, 2024 - Abstract #MTS2024MTS_233;    
    Despite comprehensive treatment with Ultibro Breezehaler and Fluticasone, his symptoms remained uncontrolled. This case report underscores the challenges involved in diagnosing and managing ACOS, particularly in the context of a patient with a history of COPD and persistent peripheral blood eosinophilia which emphasises the need for heightened clinical awareness and a deep understanding of ACOS to provide optimal care for patients with overlapping respiratory disorders.
  • ||||||||||  Enrollment open:  ANTES B+ Clinical Trial (clinicaltrials.gov) -  Mar 5, 2024   
    P4,  N=1028, Recruiting, 
    In addition, MF in the presence of indacaterol and glycopyrronium was proven to be stable at -70 Not yet recruiting --> Recruiting
  • ||||||||||  New P4 trial:  ANTES B+ Clinical Trial (clinicaltrials.gov) -  Feb 28, 2024   
    P4,  N=1028, Not yet recruiting, 
  • ||||||||||  navafenterol (AZD8871) / AstraZeneca
    Journal:  Navafenterol for chronic obstructive pulmonary disease therapy. (Pubmed Central) -  Apr 14, 2023   
    despite clinical evidence of efficacy for navafenterol is still limited the existing data prompts further clinical evaluation and also consideration of other inhalation approaches such as pressure metered dose inhalers (pMDIs) or nebulization. Other interesting approach would be combination with another bifunctional molecule such as ensifentrine.
  • ||||||||||  Ultibro (glycopyrronium/indacaterol) / Novartis
    Facilitators to recruiting COPD patients to an adherence intervention trial (Westminster, 4th floor) -  Nov 15, 2022 - Abstract #BTSWM2022BTS_WM_539;    
    The MAGNIFY cluster randomised trial is investigating the effect of a technologically-supported adherence package (Ultibro Breezhaler + adherence support technology) for COPD patients in primary care...Of the remaining 331 patients, 218 (96.1%) accepted the support package; giving an overall recruitment rate onto the intervention of 54.8% (218/398 patients).Conclusions The recruitment rate was higher than many primary care trials. Recruitment of primary care patients into intervention trials may benefit from using cluster randomised trial designs and adopting novel approaches including EMR searches and dedicated pharmacists to identify, screen and recruit potential patients.
  • ||||||||||  NN1213 / Novo Nordisk, Ultibro (glycopyrronium/indacaterol) / Novartis
    Enrollment change:  RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative (clinicaltrials.gov) -  Aug 30, 2022   
    P3,  N=780, Completed, 
    Recruitment of primary care patients into intervention trials may benefit from using cluster randomised trial designs and adopting novel approaches including EMR searches and dedicated pharmacists to identify, screen and recruit potential patients. N=534 --> 780
  • ||||||||||  Ultibro (glycopyrronium/indacaterol) / Novartis
    Trial completion:  FORELLI: Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Test Products and Reference Product (clinicaltrials.gov) -  Jul 13, 2022   
    P1,  N=24, Completed, 
    As half of non-triple users were not receiving respiratory therapy one year prior to LAMA/LABA initiation, there may be an opportunity for early optimization of treatment to relieve clinical burden versus current prescribing patterns in primary care in England. Recruiting --> Completed
  • ||||||||||  Ultibro (glycopyrronium/indacaterol) / Novartis
    Bronchodilators in Symptomatic Tobacco-exposed Persons with Preserved Spirometry for the RETHINC Study Group (8A - live streamed) -  Jun 22, 2022 - Abstract #ERS2022ERS_738;    
    We randomized 535 participants with ≥10 pack-years smoking history, respiratory symptoms defined by COPD Assessment Test (CAT) score ≥10, and preserved spirometry (post-bronchodilator FEV1 /FVC ≥0.70) to indacaterol/glycopyrrolate 27.5/15.6 mcg inhalation or blinded placebo twice daily for twelve weeks...The change in FEV1 (% predicted) was 2.48 (95% CI, 1.49 to 3.47) in the intervention group and -0.09 (95% CI, -1.06 to 0.89) in the placebo group; the change in inspiratory capacity (L) was 0.12 (95% CI, 0.07 to 0.18) in the intervention group and 0.02 (95% CI, -0.03 to 0.08) in the placebo group, respectively. Inhaled dual bronchodilator therapy did not improve respiratory symptoms in symptomatic, tobacco-exposed persons with preserved spirometry.
  • ||||||||||  Ultibro (glycopyrronium/indacaterol) / Novartis
    Patient-reported barriers to accepting a technological adherence package in the MAGNIFY trial. (TP-3 in thematic poster area) -  Jun 22, 2022 - Abstract #ERS2022ERS_199;    
    Eligible patients received a phone call from a pharmacist who conducted a remote patient review and invited them to use the digital support package, comprising an Ultibro Breezhaler and adherence support technology...Conclusions Most patients declined the adherence package for practical reasons, such as lacking a compatible smartphone, rather than unwillingness to use technology. Though this is interim data from a single trial, it suggests that technophobia may not be an important barrier to patients accepting technological adherence support.
  • ||||||||||  Ultibro (glycopyrronium/indacaterol) / Novartis
    Retrospective data, Journal:  PREFUL MRI Depicts Dual Bronchodilator Changes in COPD: A Retrospective Analysis of a Randomized Controlled Trial. (Pubmed Central) -  May 6, 2022   
    To assess whether dynamic ventilation and perfusion (Q) biomarkers derived by phase-resolved functional lung (PREFUL) MRI can measure treatment response to 14-day therapy with indacaterol-glycopyrronium (IND-GLY) and correlate to clinical outcomes including lung function, symptoms, and cardiac function in patients with chronic obstructive pulmonary disease (COPD), as determined by spirometry, body plethysmography, cardiac MRI, and dyspnea score measurements...Clinical trial registration no. NTR6831Keywords: MRI, COPD, Perfusion, Ventilation, Lung, PulmonaryPublished under a CC BY 4.0 license.
  • ||||||||||  Spiriva Respimat (tiotropium bromide) / Boehringer Ingelheim, NN1213 / Novo Nordisk, Ultibro (glycopyrronium/indacaterol) / Novartis
    Trial completion:  INTUITIVE: Description of the Ability to Learn How to Handle Inhaler Devices in COPD (clinicaltrials.gov) -  Feb 14, 2022   
    P4,  N=24, Completed, 
    The present findings may provide necessary quantitative information for COPD medication guidelines. Not yet recruiting --> Completed
  • ||||||||||  Clinical, Journal:  Which LABA/LAMA should be chosen in COPD patients in real life? (Pubmed Central) -  Jan 28, 2022   
    According to our retrospective database study, each LABA/LAMA could have a specific efficacy profile in COPD that might be considered for personalized therapy. However, head-to-head targeted trials aimed to assess the impact of different LABA/LAMAs on COPD are needed to confirm/disprove such results.
  • ||||||||||  Ultibro (glycopyrronium/indacaterol) / Novartis
    Preclinical, Journal:  Optimization and Application of an Efficient and Stable Inhalation Exposure System for Rodents. (Pubmed Central) -  Jan 14, 2022   
    Indacaterol glycopyrronium bromide inhalation powder (IM/GP mixed powder) is composed of indacaterol maleate and glycopyrronium bromide powder to treat chronic obstructive pulmonary disease (COPD)...Results showed that the stability of powder aerosols can be realized under the atomization generation flow: 10 L/min, sampling flow: 2 L/min, system pumping capacity: 10 L/min and powder scraper speed: 8-10 L/min, and there were no significant adverse effects on body weight, clinic signs, hematology, and pathology in rats. Overall, the results suggested that the IM/GP mixed powder inhalation at the dose of 2.6 mg/kg/d can be reached when the aerosol concentration is within the range of 200 ± 20% mg/m, and there were no pulmonary toxicity effects in rats.
  • ||||||||||  NN1213 / Novo Nordisk, Ultibro (glycopyrronium/indacaterol) / Novartis
    Trial completion:  RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative (clinicaltrials.gov) -  Nov 16, 2021   
    P3,  N=534, Completed, 
    Both LABA/LAMAs versus salmeterol/fluticasone are associated with a lower exacerbation rate and pneumonia risk, but exhibit similar effectiveness and safety outcomes compared with formoterol/beclomethasone or formoterol/budesonide, suggesting that comparative effects may differ by individual components of the dual therapies in COPD. Active, not recruiting --> Completed
  • ||||||||||  Ultibro (glycopyrronium/indacaterol) / Novartis
    Trial completion:  FINDA: Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler (clinicaltrials.gov) -  Sep 27, 2021   
    P1,  N=34, Completed, 
    Trial completion date: Mar 2022 --> Mar 2023 | Trial primary completion date: Oct 2021 --> Oct 2022 Recruiting --> Completed
  • ||||||||||  Ultibro (glycopyrronium/indacaterol) / Novartis
    Clinical, Journal:  Relieving exertional dyspnea during the 3-min constant speed shuttle test in patients with COPD with indacaterol/glycopyrronium versus tiotropium: the RED trial. (Pubmed Central) -  Sep 17, 2021   
    Despite indacaterol/glycopyrronium providing further bronchodilation and lung deflation throughout the trial, the reduction in dyspnea was not sustained at 3 weeks of treatment (mean between-treatment difference at 3 weeks of 0.09, 95% CI -0.44 to 0.61). In comparison with bronchodilator monotherapy, indacaterol/glycopyrronium provided greater immediate exertional dyspnea relief, although this difference was not sustained after 3 weeks of therapy despite evidence of further bronchodilation and lung deflation.The reviews of this paper are available via the supplemental material section.