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Review, Journal: Experimental Glucocorticoid Receptor Agonists for the Treatment of Asthma: A Systematic Review. (Pubmed Central) - Sep 30, 2020 Several compounds are currently under pre-clinical development, but only three novel experimental GR agonists (GW870086X, AZD5423, AZD7594) seem to have some potential therapeutic relevance and have entered clinical trials for the treatment of asthma. Since data from pre-clinical studies have not always been confirmed in clinical investigations, well-designed randomized controlled trials are needed in asthmatic patients to confirm the potentially positive benefit/risk ratio of each specific SEGRA and to optimize the development strategy of these agents in respiratory medicine.
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Design of a Phase 1 Virtual Hybrid Study of AZD7594, an Inhaled Non-Steroidal, Selective Glucocorticoid Receptor Modulator, in Adolescents with Asthma (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area C) - Mar 15, 2020 - Abstract #ATS2020ATS_7106; P2b For the first time, we will run a virtual hybrid clinical trial concept, adapting the trial around the patient by (Figure);● Home nursing visits to perform PK-sampling, spirometry and plasma cortisol as pharmacodynamic (PD) assessments and safety evaluation through physical examination, electrocardiogram vital signs, adverse events and laboratory measurements.● Telemedicine visits through a digital platform for real time video consultations with the physician at study site, as well as capturing daily diary data regarding SABA use and ACQ-5, reading and signing informed consent form, visit scheduling and caregiver/patient end of study evaluation.● Remote PK and PD through a finger-prick micro-sampling device will be explored, with the aim of reducing lengthy and burdensome blood sampling in future trials.Conclusion The results of this study will characterize the PK, PD and safety of AZD7594 in adolescents with GINA 2 asthma. The hybrid virtual study concept will provide detailed insight into the feasibility of similar designs in this age group.
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Enrollment closed, Enrollment change: A Study to Evaluate the Disposition of Drug in Body and Safety After Administration of Single Inhaled Doses of Drugs Abediterol and AZD7594 Administered Alone, in Fixed Dose Combination and in Free Combination Using the Dry Powder Inhaler in Healthy Male Participants (clinicaltrials.gov) - Feb 1, 2017 P1, N=14, Active, not recruiting, Recruiting --> Active, not recruiting | N=18 --> 12 Recruiting --> Active, not recruiting | N=32 --> 14
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