Study identifier:D5982C00005
ClinicalTrials.gov identifier:NCT05755906
EudraCT identifier:2021-003334-36
CTIS identifier:N/A
A Randomized, Double-Blind, Parallel Group, Multicenter 12 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants with Inadequately Controlled Asthma (LITHOS)
asthma
Phase 3
No
BFF MDI 160/9.6 μg BID (320/19.2μg/day), BD MDI 160 μg BID (320 μg/day)
All
373
Interventional
12 Years - 80 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
-
This is a 12-week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler relative to budesonide metered dose inhaler in adults and adolescents with inadequately controlled asthma.
This is a Phase III, randomized, double-blind, parallel group, multicenter study comparing Budesonide and Formoterol Fumarate Metered Dose Inhaler (BFF MDI) 160/9.6 μg twice daily (BID) to Budesonide MDI 160 μg (BD MDI), over 12 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 low dose inhaled corticosteroid (ICS) or ICS/long-acting beta2-agonist (LABA). This study is to assess the benefits and safety of BFF MDI on lung function and asthma health-related quality of life. This study will be conducted at approximately 90 sites worldwide and will randomize approximately 340 adult and adolescent participants.
Location
Location
Lovosice, Czech Republic, 410 02
Location
Teplice, Czech Republic, 415 01
Location
Varnsdorf, Czech Republic, 407 47
Location
Praha 9, Czech Republic, 190 00
Location
Jindrichuv Hradec, Czech Republic, 377 01
Location
White Marsh, MD, United States, 21162
Location
Huntington Beach, CA, United States, 92647
Location
Los Angeles, CA, United States, 90025
Arms | Assigned Interventions |
---|---|
Experimental: BFF MDI 160/9.6 μg BID (320/19.2μg/day) Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), BDI (320/19.2μg/day) | Drug: BFF MDI 160/9.6 μg BID (320/19.2μg/day) Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg BID (320/19.2μg/day) Other Name: BFF |
Active Comparator: BD MDI 160 μg BID (320 μg/day) Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day) | Drug: BD MDI 160 μg BID (320 μg/day) Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day) Other Name: BD |
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