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A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort Turbuhaler as an Active Control in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

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Trial Profile

A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort Turbuhaler as an Active Control in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Nov 2023

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At a glance

  • Drugs Budesonide/formoterol/glycopyrrolate (Primary) ; Budesonide/formoterol; Formoterol/glycopyrrolate
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms KRONOS
  • Sponsors Pearl Therapeutics

Most Recent Events

  • 24 May 2023 Results of a post-hoc analysis assessing exacerbation rates with BGF versus dual therapies in this study based on airflow limitation presented at the 119th International Conference of the American Thoracic Society
  • 24 Oct 2022 According to an AstraZeneca media release, based on the results of this ETHOS and KRONOS studies, the company announced the Canadian availability of Breztri, indicated for the long-term maintenance treatment to reduce exacerbations of chronic obstructive pulmonary disease (COPD) and treat airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema who are not adequately treated by a combination of an ICS/LABA or a combination of a LAMA/LABA.
  • 28 Apr 2022 Results of cost-effectiveness of Budesonide/formoterol/glycopyrrolate in patients with moderate to very severe COPD from a Chinese healthcare system perspective published in the Applied Health Economics and Health Policy

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