- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Trial completion date, Trial primary completion date, Adherence: ADITION: Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions (clinicaltrials.gov) - Jan 31, 2022 P=N/A, N=1000, Recruiting, Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2022 --> Dec 2022
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Journal: Inhaled indacaterol/glycopyrronium/mometasone furoate fixed-dose combination in moderate-to-severe asthma. (Pubmed Central) - Jan 29, 2022 The recently approved single-inhaler indacaterol/glycopyrronium/mometasone fixed dose combination has demonstrated to significantly reduce exacerbations, improve FEV, symptoms and quality of life compared to ICS/LABA, including, salmeterol/fluticasone combination. Moreover, once-daily dosing may improve adherence.
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: XPERTT: Investigating the Effects of QVM149 on MRI Ventilation Defects (clinicaltrials.gov) - Dec 14, 2021 P3, N=0, Withdrawn, On a population level, the pharmacokinetics of IND and GLY were comparable between patients with asthma and COPD. N=48 --> 0 | Trial completion date: Jul 2021 --> Dec 2022 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jul 2021 --> Jul 2022
- |||||||||| Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Clinical, Review, Journal: Dose bridging data for mometasone furoate in once-daily fixed-dose inhaled combinations of mometasone furoate/indacaterol and mometasone furoate/ indacaterol/glycopyrronium in patients with asthma. (Pubmed Central) - Nov 6, 2021 Following this stepwise approach, it was determined that mometasone furoate 80 μg o.d. (medium dose strength) and 160 μg o.d. (high dose strength) in mometasone furoate/indacaterol acetate/glycopyrronium bromide formulation provided comparable inhaled corticosteroid efficacy to mometasone furoate 160 μg o.d. (medium dose strength) and 320 μg o.d. (high dose strength) in the mometasone furoate/indacaterol acetate formulation, respectively. These doses were used in the PLATINUM Phase III clinical program that investigated the efficacy and safety of mometasone furoate/indacaterol acetate and mometasone furoate/indacaterol acetate/glycopyrronium bromide combinations in patients with asthma.
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Review, Journal: Indacaterol/Glycopyrronium/Mometasone: A Review in Asthma. (Pubmed Central) - Nov 4, 2021 Indacaterol/glycopyrronium/mometasone was generally well tolerated, and the most common adverse events were respiratory in nature. In conclusion, combination therapy with indacaterol/glycopyrronium/mometasone represents a valuable option for the maintenance treatment of asthma, with the convenience of once-daily administration via a single inhaler.
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Journal: Fixed combination of mometasone, indacaterol, glycopyrronium for the treatment of severe asthma : Enerzair® Breezhaler® (Pubmed Central) - Oct 12, 2021 As compared to an ICS/LABA combination Enerzair® improves expiratory flow rates and reduces exacerbation rate. The Breezhaler® device may be coupled to a sensor (Propeller Health) that, through a bluetooth system, allows to control patient adherence and provides recall to the patient to take his aerosol.
- |||||||||| Onbrez (indacaterol) / Novartis
Clinical, Journal: Numerical simulation of the effect of inhalation parameters, gender, age and disease severity on the lung deposition of dry powder aerosol drugs emitted by Turbuhaler®, Breezhaler® and Genuair® in COPD patients. (Pubmed Central) - May 27, 2021 Mean values and distributions of the deposited lung doses proved to be both drug and device specific, yielding 24.2 (±7.8), 22.6 (±3.6), 34.2 (±4.8) and 23.9 (±5.4) % values for Symbicort®, Onbrez®, Seebri® and Bretaris®, respectively...A more powerful inhalation significantly increases the lung dose for the drug emitted by Turbuhaler®, while long breath-hold is likely to yield significantly higher deposition for drugs emitted by Breezhaler® and Genuair®. Lung doses of two different drugs dispensed in the same inhaler can be significantly different.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Preclinical, Journal: NPC1L1 and ABCG5/8 induction explain synergistic fecal cholesterol excretion in ob/ob mice co-treated with PPAR-α and LXR agonists. (Pubmed Central) - Apr 29, 2021 Synergistic efficacy on fecal cholesterol excretion following co-treatment with PPAR-α and LXR agonists occurred through a combination of RCT, TICE, and the key enzyme in bile synthesis, cholesterol 7-α hydroxylase (cyp7a1). These results suggest that cholesterol efflux, biliary cholesterol excretion, and TICE collectively contributed to the 12-fold increases in the fecal cholesterol excretion in ob/ob mice co-treated with PPAR-α and LXR agonists.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Journal: Toxicity Screens in Human Retinal Organoids for Pharmaceutical Discovery. (Pubmed Central) - Apr 17, 2021 This is a directly actionable finding owing to the highly disease-relevant model tested. This platform can be easily modified to test any number of metabolic stressors and potential pharmacological interventions for future treatment discovery in retinal diseases.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Clinical, Journal: Reducing Cardiovascular Disease Risk in Women Beyond Statin Therapy: New Insights 2020. (Pubmed Central) - Apr 13, 2021 CVD risk reduction with icosapent ethyl treatment was comparable between women and men (p for interaction, 0.33). Data from REDUCE-IT suggest women benefit similarly to men with respect to icosapent ethyl, a novel therapy for prevention of CVD.
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