LOGOS

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 to 52 Week Variable Length Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (MDI) Relative to Budesonide and Formoterol Fumarate MDI and Symbicort® Pressurized MDI in Adult and Adolescent Participants with Inadequately Controlled Asthma

• IRAS ID

  1003747

• Contact name

  Vaishali Khedekar

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2020-001521-31

• Clinicaltrials.gov Identifier

  NCT04609904

• Research summary

  This study will evaluate the efficacy and safety of BGF (Budesonide/Glycopyrronium/Formoterol Fumarate) MDI (metered dose inhaler) twice daily (BID) compared with BFF (Budesonide and Formoterol Fumarate MDI BID, and Symbicort® pressurized metered dose inhaler (pMDI) BID, over a variable length treatment period, between 24 weeks and a maximum of 52 weeks. The study population will consist of adult and adolescent participants with asthma who remain inadequately controlled, as demonstrated by an Asthma Control Questionnaire (ACQ)-7 total score ≥1.5, despite treatment with a medium or high dose of inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA). Adult participants (but not adolescents) must also have a documented history of at least one severe asthma exacerbation in the 12 months prior to Visit 1. This study is one of two confirmatory Phase III studies (LOGOS and KALOS) with identical designs to demonstrate benefits on reducing severe asthma exacerbations, improving lung function and health-related quality of life. The two studies are identical except for 3 additional data collections in KALOS on continuous electrical activities of the heart (24-hour Holter Monitor), lung functions (12-hour spirometry) and how the body affects the study drugs (12-hour pharmacokinetic), and LOGOS has only one additional data collection on lung functions (12-hour spirometry). The two studies will be combined for exacerbation analyses and 12-hour spirometry sub-study analyses to obtain adequate numbers of participants to support a better understanding of the benefits of the study drug for this subject population.

• REC name

  HSC REC A

• REC reference

  21/NI/0102

• Date of REC Opinion

  16 Aug 2021

• REC opinion

  Further Information Favourable Opinion