What side effects are associated with this type of intervention?

Inhaled corticosteroids (ICS) like Budesonide are commonly associated with side effects such as oral thrush, hoarseness, and an increased risk of pneumonia. Long-term use may also lead to systemic effects like adrenal suppression and decreased bone mineral density. Long-acting beta-agonists (LABA) like Formoterol Fumarate can cause side effects including tremors, palpitations, and an increased risk of asthma-related death if used as monotherapy. When used in combination, as in Budesonide and Formoterol Fumarate inhalers, these medications are generally well-tolerated but still carry the risk of the aforementioned side effects.

What prior FDA approvals exist?

The FDA has approved several combination inhalers for the treatment of asthma that include an inhaled corticosteroid (ICS) and a long-acting beta-agonist (LABA), similar to Budesonide and Formoterol Fumarate. Notable examples include Fluticasone Propionate and Salmeterol (Advair), Budesonide and Formoterol (Symbicort), and Fluticasone Furoate and Vilanterol (Breo Ellipta). These combinations are designed to provide both anti-inflammatory effects and long-term bronchodilation, helping to manage and control asthma symptoms effectively.

What other types of research exist?

Promising novel alternatives to Budesonide and Formoterol Fumarate for asthma patients include: 1) Fluticasone Furoate-Umeclidinium-Vilanterol (FF/UM/VI), a triple therapy inhaler that has shown improved lung function and reduced exacerbations in clinical trials. 2) Beclomethasone-Glycopyrronium-Formoterol, another triple combination inhaler under investigation, which may offer enhanced control of asthma symptoms. 3) Mepolizumab, a monoclonal antibody targeting IL-5, which is effective in reducing exacerbations in patients with severe eosinophilic asthma.

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Corticosteroid

Budesonide + Formoterol for Asthma (LITHOS Trial)

Q: What is the mechanism of action of this treatment?

Asthma treatments commonly include anti-inflammatory corticosteroids and long-acting beta-agonist (LABA) bronchodilators. Anti-inflammatory corticosteroids, such as Budesonide, work by reducing inflammation and swelling in the airways, which helps to prevent asthma attacks and improve breathing. Long-acting beta-agonists, like Formoterol Fumarate, relax the muscles around the airways, making it easier to breathe and providing long-term control of asthma symptoms. The combination of these two types of medications is particularly effective because it addresses both the underlying inflammation and the bronchoconstriction that characterize asthma, leading to better overall management of the condition.

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pre-bronchodilator/pre-dose FEV1 < 90% predicted normal value at Visits 1, 2, and 3 and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization)

Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of ≥ 12% and ≥ 200 mL for participants ≥ 18 years of age OR a post-albuterol increase in FEV1 of ≥ 12% for participants 12 to < 18 years of age

Must not have

Use of a nebulizer or a home nebulizer for receiving asthma medications

For women only - currently pregnant, breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 12

Awards & highlights

Summary

This trial tests if two inhalers are better than one to control asthma in adults & teens.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Potential side effects may include throat irritation, hoarseness, thrush in the mouth or throat, coughing, headaches, increased heart rate/palpitations, tremors/shakiness and possible worsening of asthma symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My lung function improves significantly after taking albuterol.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use a nebulizer for my asthma treatment.

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I am not pregnant, breastfeeding, planning to become pregnant, or I am using effective birth control.

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My cancer cannot be removed by surgery and has not been fully gone for 5 years.

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I will be hospitalized during the study.

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I have had severe asthma attacks that required breathing support.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 12 Weeks

Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1

Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) at Week 12

+3 more

Trial Design

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)

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Asthma treatments commonly include anti-inflammatory corticosteroids and long-acting beta-agonist (LABA) bronchodilators. Anti-inflammatory corticosteroids, such as Budesonide, work by reducing inflammation and swelling in the airways, which helps to prevent asthma attacks and improve breathing. Long-acting beta-agonists, like Formoterol Fumarate, relax the muscles around the airways, making it easier to breathe and providing long-term control of asthma symptoms. The combination of these two types of medications is particularly effective because it addresses both the underlying inflammation and the bronchoconstriction that characterize asthma, leading to better overall management of the condition.