A 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)

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: BFF MDI 160/9.6 μg BID (320/19.2μg/day); Drug: BD MDI 160 μg BID (320 μg/day)

• Registration Number: NCT05755906
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-02-23
• Study Start: 2023-02-27
• Study First Posted: 2023-03-06
• Primary Completion: 2024-11-19
• Study Completion: 2024-11-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BFF MDI 160/9.6 μg BID (320/19.2μg/day)	BFF MDI 160/9.6 μg BID (320/19.2μg/day)	Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), BDI (320/19.2μg/day)
BD MDI 160 μg BID (320 μg/day)	BD MDI 160 μg BID (320 μg/day)	Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day)

Primary Outcome Measures

Name	Time	Method
United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 12	at week 12	United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 12

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 12 Weeks	over 12 Weeks	Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 12 Weeks
Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) at Week 12	at Week 12	Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) at Week 12
Percentage of responders in ACQ-7 (≥ 0.5 decrease equals response) at Week 12	at Week 12	Percentage of responders in ACQ-7 (≥ 0.5 decrease equals response) at Week 12
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1	on Day 1	Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1 (within group comparison)
US (Key secondary): Change from baseline in morning pre-dose trough FEV1 at Week 12	at week 12	US (Key secondary): Change from baseline in morning pre-dose trough FEV1 at Week 12
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s) +12) (≥ 0.5 increase equals response) at Week 12	at Week 12	Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s) +12)(≥ 0.5 increase equals response) at Week 12

Trial Locations

Locations (1)

Research Site; 🇿🇦 Tygervalley, South Africa