Budesonide + Formoterol for Asthma
(LITHOS Trial)

Recruiting in Palo Alto (17 mi)

+112 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests two inhalers for asthma in patients whose condition isn't well-controlled with current treatments. One inhaler combines two medications to reduce inflammation and open airways, while the other only reduces inflammation. The combination of budesonide and formoterol in a single inhaler has been shown to improve asthma control by providing both maintenance and reliever therapy.

Research Team

Eligibility Criteria

This trial is for adults and adolescents aged 12-80 with poorly controlled asthma, a BMI under 40, and who can use an inhaler correctly. Women of childbearing age must use effective birth control. Participants should have been on a stable inhaled corticosteroid (ICS) or ICS/LABA regimen for at least 8 weeks, have consistent lung function measurements, and not be current smokers or recent quitters.

Inclusion Criteria

ACQ-7 total score ≥ 1.5 at Visits 1 and 4

Demonstrate acceptable MDI administration technique

My lung function tests show less than 90% of the expected value before treatment.

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Exclusion Criteria

Involvement in the planning and/or conduct of the study

Known history of drug or alcohol abuse within 12 months of Visit 1

Previous or current randomization into studies within the AEROSPHERE program or any glycopyrronium studies

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Treatment Details

Interventions

Budesonide (Corticosteroid)
Formoterol Fumarate (Bronchodilator)

Trial OverviewThe study compares the effectiveness of two asthma treatments over 12 weeks: Budesonide/Formoterol Fumarate Metered Dose Inhaler (BFF MDI) versus Budesonide Metered Dose Inhaler (BD MDI). It aims to determine if adding formoterol improves asthma control compared to budesonide alone.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: BFF MDI 160/9.6 μg BID (320/19.2μg/day)Experimental Treatment1 Intervention

Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), BDI (320/19.2μg/day)

Group II: BD MDI 160 μg BID (320 μg/day)Active Control1 Intervention

Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day)

Budesonide is already approved in Canada for the following indications: